e-commerce, dietary supplement regulations and · pdf filee-commerce, dietary supplement...
TRANSCRIPT
Nutrition Industry Association May 2017 John Venardos Venardos amp Associates LLC Regulatory and Government Affairs Counsellors johnvenardos1gmailcom
E-COMMERCE DIETARY SUPPLEMENT REGULATIONS AND A FRACTURED INDUSTRY
bull Judy Wallman a professional genealogy researcher in California was looking into her own family tree
bull She learned Senator Harry Reids great uncle Remus Reid was hanged for horse stealing and train robbery in Montana in 1889 Both Judy and Harry Reid shared this common ancestor This is the only known photograph of on the Montana gallows
IN DC ITrsquoS HOW YOU SPIN IT
2
bull On the back of the picture Judy obtained during her research is this inscription Remus Reid horse thief sent to Montana Territorial Prison 1885 escaped 1887 robbed the Montana Flyer six times Caught by Pinkerton detectives convicted and hanged in 1889 So Judy e-mailed Senator Harry Reid asking for information about their great uncle
IN DC ITrsquoS HOW YOU SPIN IT
3
bull Reids staff sent back the following biographical sketch for her genealogy research
Remus Reid was a famous cowboy in the Montana Territory His business empire grew to include acquisition of valuable equestrian assets and intimate dealings with the Montana railroad Beginning in 1883 he devoted several years of his life to government service finally taking leave to resume his dealings with the railroad In 1887 he was a key player in a vital investigation run by the renowned Pinkerton Detective Agency In 1889 Remus passed away during an important civic function held in his honor when the platform upon which he was standing collapsed
IN DC ITrsquoS HOW YOU SPIN IT
4
bull The world of e-commerce bull DSHEA at 23 bull Report card on FDArsquos Office of Dietary Supplement Programs bull What we can expect from FTC post-Ramirez bull Miscellaneous developments bull The elephants in the room bull Takeaways bull QampA
SCOPE OF TODAYrsquoS PRESENTATION
5
DO WE HAVE A LEVEL PLAYING FIELD
6
bull Amazon Estimated Visits 1088000000 UVs 144000000
bull Bodybuildingcom 12500 products Estimated Visits 21000000 UVs 3700000
bull Clickbank Claims 200000000 million customers (supplements = some 10 sales)
bull Costcocom
bull GNCcom Estimated Visits 2000000 UVs 1000000
bull Iherb 35000 products
bull Netritioncom Estimated Visits 160000 UVs 50000
bull Optimum Nutritioncom Estimated Visits 240000 UVs 100000
bull Supplementwarehousecom Selling DMAA Beta alanine sourcing issue
bull Vitacostcom 45000 products
bull VitaminShoppecom Estimated Visits 180000 UVs 30000
THE WORLD OF E-COMMERCE
7
THE WORLD OF E-COMMERCE
8
THE WORLD OF E-COMMERCE
bull Netrush (wwwnetrushcom) presented on Amazon at CRN 2016
bull Netrush is ldquoa leading retailer and agency that partners with brands to grow and manage their products on the Amazon Marketplacerdquo Here is their storefront on Amazon bull (httpswwwamazoncomgpnodeindexhtmlie=UTF8ampmarketplaceI
D=ATVPDKIKX0DERampme=A2G7B63FOSFZJZampmerchant=A2G7B63FOSFZJZampredirect=true)
bull Items are fulfilled by Amazon but sold by Netrush (Netrush may hold inventory at a KY FC and ship to Amazon as quantities deplete)
bull Netrush Director of Strategy Raj Sapru told CRN ldquoThere is Law and then there is Amazon Lawrdquo
bull He added ldquoAmazon doesnrsquot believe in bordersrdquo
9
THE WORLD OF E-COMMERCE
bull Today one can order from 247144 unique dietary supplements available for delivery from Amazon
bull Some have observed what may be contradictions between Amazonrsquos Policy and products available for sale on Amazon labeled as supplements httpswwwnaturalproductsinsidercom~mediaFilesNutritionWhitepapers201703selling-dietary-supplements-on amazonpdf
10
THE WORLD OF E-COMMERCE
bull This link shows Amazonrsquos policy on prohibited listings of supplements httpswwwamazoncomgphelpcustomerdisplayhtmlref=help_search_1-1ie=UTF8ampnodeId=201829030ampqid=1490383280ampsr=1-1
11
THE WORLD OF E-COMMERCE
bull Examples of prohibited listings
bull Homeopathic drugs that are prescription mislabeled or unapproved new drugs
bull httpswwwamazoncomHylands-Calcarea-Sulphurica-Tablets-HomeopathicdpB001E8GGOQref=sr_1_12_a_itie=UTF8ampqid=1490390438ampsr=8-12ampkeywords=homeopathicampth=1
12
THE WORLD OF E-COMMERCE
bull Patches marketed as dietary supplements
bull httpswwwamazoncomPalmetto-Prostate-Transdermal-Patches-SupplydpB013RU7KMKref=sr_1_5_a_itie=UTF8ampqid=1490390665ampsr=8-5ampkeywords=patch+supplement
bull Supplements claiming that they can be used to cure mitigate treat or prevent disease in humans
bull httpswwwamazoncomAyurvedic-Supplement-Formulation-Naturally-SensitivitydpB01LF2FIO4ref=sr_1_21_a_itie=UTF8ampqid=1490390950ampsr=8-21ampkeywords=diabetes+supplement
13
THE WORLD OF E-COMMERCE
bull Sexual enhancement products
bull httpswwwamazoncomAlphaMAN-XL-Sexual-Enhancement-InchesdpB01N0APH2Oref=sr_1_1_a_itie=UTF8ampqid=1490390752ampsr=8-1ampkeywords=penis+growth
bull Supplement listings that include disease names in their keywords
bull httpswwwamazoncomgpsearchref=a9_asi_1rh=i3Aaps2Ck3Ahigh+cholesterol+supplementampkeywords=high+cholesterol+supplementampie=UTF8ampqid=1490391231
14
THE WORLD OF E-COMMERCE
bull Products on USADA list of high-risk supplements such as
bull Driven Sports ndash Craze
bull LG Sciences ndash Formadrol Extreme
bull Isatori Bio-Gro listed as banned by USADA
bull httpswwwamazoncomBio-Gro-Chocolate-Ice-CreamdpB01F1CJ3P4ref=sr_1_5_a_itie=UTF8ampqid=1490391758ampsr=8-5ampkeywords=bio-gro
15
THE WORLD OF E-COMMERCE bull GMP concerns
bull Does Amazon hold supplements in cGMP compliant facilities
bull A number of ds available for sale on Amazonrsquos portal are labeled with the recommendation to store in a cool dry place
bull Here are Fulfillment by Amazon criteria from their website
bull Based on the above requirements it appears Amazon holds some products in temperature-controlled conditions as required by vendors
bull httpswwwamazoncomgphelpcustomerdisplayhtmlref=hp_rel_topicie=UTF8ampnodeId=200339730
bull bull
16
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Judy Wallman a professional genealogy researcher in California was looking into her own family tree
bull She learned Senator Harry Reids great uncle Remus Reid was hanged for horse stealing and train robbery in Montana in 1889 Both Judy and Harry Reid shared this common ancestor This is the only known photograph of on the Montana gallows
IN DC ITrsquoS HOW YOU SPIN IT
2
bull On the back of the picture Judy obtained during her research is this inscription Remus Reid horse thief sent to Montana Territorial Prison 1885 escaped 1887 robbed the Montana Flyer six times Caught by Pinkerton detectives convicted and hanged in 1889 So Judy e-mailed Senator Harry Reid asking for information about their great uncle
IN DC ITrsquoS HOW YOU SPIN IT
3
bull Reids staff sent back the following biographical sketch for her genealogy research
Remus Reid was a famous cowboy in the Montana Territory His business empire grew to include acquisition of valuable equestrian assets and intimate dealings with the Montana railroad Beginning in 1883 he devoted several years of his life to government service finally taking leave to resume his dealings with the railroad In 1887 he was a key player in a vital investigation run by the renowned Pinkerton Detective Agency In 1889 Remus passed away during an important civic function held in his honor when the platform upon which he was standing collapsed
IN DC ITrsquoS HOW YOU SPIN IT
4
bull The world of e-commerce bull DSHEA at 23 bull Report card on FDArsquos Office of Dietary Supplement Programs bull What we can expect from FTC post-Ramirez bull Miscellaneous developments bull The elephants in the room bull Takeaways bull QampA
SCOPE OF TODAYrsquoS PRESENTATION
5
DO WE HAVE A LEVEL PLAYING FIELD
6
bull Amazon Estimated Visits 1088000000 UVs 144000000
bull Bodybuildingcom 12500 products Estimated Visits 21000000 UVs 3700000
bull Clickbank Claims 200000000 million customers (supplements = some 10 sales)
bull Costcocom
bull GNCcom Estimated Visits 2000000 UVs 1000000
bull Iherb 35000 products
bull Netritioncom Estimated Visits 160000 UVs 50000
bull Optimum Nutritioncom Estimated Visits 240000 UVs 100000
bull Supplementwarehousecom Selling DMAA Beta alanine sourcing issue
bull Vitacostcom 45000 products
bull VitaminShoppecom Estimated Visits 180000 UVs 30000
THE WORLD OF E-COMMERCE
7
THE WORLD OF E-COMMERCE
8
THE WORLD OF E-COMMERCE
bull Netrush (wwwnetrushcom) presented on Amazon at CRN 2016
bull Netrush is ldquoa leading retailer and agency that partners with brands to grow and manage their products on the Amazon Marketplacerdquo Here is their storefront on Amazon bull (httpswwwamazoncomgpnodeindexhtmlie=UTF8ampmarketplaceI
D=ATVPDKIKX0DERampme=A2G7B63FOSFZJZampmerchant=A2G7B63FOSFZJZampredirect=true)
bull Items are fulfilled by Amazon but sold by Netrush (Netrush may hold inventory at a KY FC and ship to Amazon as quantities deplete)
bull Netrush Director of Strategy Raj Sapru told CRN ldquoThere is Law and then there is Amazon Lawrdquo
bull He added ldquoAmazon doesnrsquot believe in bordersrdquo
9
THE WORLD OF E-COMMERCE
bull Today one can order from 247144 unique dietary supplements available for delivery from Amazon
bull Some have observed what may be contradictions between Amazonrsquos Policy and products available for sale on Amazon labeled as supplements httpswwwnaturalproductsinsidercom~mediaFilesNutritionWhitepapers201703selling-dietary-supplements-on amazonpdf
10
THE WORLD OF E-COMMERCE
bull This link shows Amazonrsquos policy on prohibited listings of supplements httpswwwamazoncomgphelpcustomerdisplayhtmlref=help_search_1-1ie=UTF8ampnodeId=201829030ampqid=1490383280ampsr=1-1
11
THE WORLD OF E-COMMERCE
bull Examples of prohibited listings
bull Homeopathic drugs that are prescription mislabeled or unapproved new drugs
bull httpswwwamazoncomHylands-Calcarea-Sulphurica-Tablets-HomeopathicdpB001E8GGOQref=sr_1_12_a_itie=UTF8ampqid=1490390438ampsr=8-12ampkeywords=homeopathicampth=1
12
THE WORLD OF E-COMMERCE
bull Patches marketed as dietary supplements
bull httpswwwamazoncomPalmetto-Prostate-Transdermal-Patches-SupplydpB013RU7KMKref=sr_1_5_a_itie=UTF8ampqid=1490390665ampsr=8-5ampkeywords=patch+supplement
bull Supplements claiming that they can be used to cure mitigate treat or prevent disease in humans
bull httpswwwamazoncomAyurvedic-Supplement-Formulation-Naturally-SensitivitydpB01LF2FIO4ref=sr_1_21_a_itie=UTF8ampqid=1490390950ampsr=8-21ampkeywords=diabetes+supplement
13
THE WORLD OF E-COMMERCE
bull Sexual enhancement products
bull httpswwwamazoncomAlphaMAN-XL-Sexual-Enhancement-InchesdpB01N0APH2Oref=sr_1_1_a_itie=UTF8ampqid=1490390752ampsr=8-1ampkeywords=penis+growth
bull Supplement listings that include disease names in their keywords
bull httpswwwamazoncomgpsearchref=a9_asi_1rh=i3Aaps2Ck3Ahigh+cholesterol+supplementampkeywords=high+cholesterol+supplementampie=UTF8ampqid=1490391231
14
THE WORLD OF E-COMMERCE
bull Products on USADA list of high-risk supplements such as
bull Driven Sports ndash Craze
bull LG Sciences ndash Formadrol Extreme
bull Isatori Bio-Gro listed as banned by USADA
bull httpswwwamazoncomBio-Gro-Chocolate-Ice-CreamdpB01F1CJ3P4ref=sr_1_5_a_itie=UTF8ampqid=1490391758ampsr=8-5ampkeywords=bio-gro
15
THE WORLD OF E-COMMERCE bull GMP concerns
bull Does Amazon hold supplements in cGMP compliant facilities
bull A number of ds available for sale on Amazonrsquos portal are labeled with the recommendation to store in a cool dry place
bull Here are Fulfillment by Amazon criteria from their website
bull Based on the above requirements it appears Amazon holds some products in temperature-controlled conditions as required by vendors
bull httpswwwamazoncomgphelpcustomerdisplayhtmlref=hp_rel_topicie=UTF8ampnodeId=200339730
bull bull
16
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull On the back of the picture Judy obtained during her research is this inscription Remus Reid horse thief sent to Montana Territorial Prison 1885 escaped 1887 robbed the Montana Flyer six times Caught by Pinkerton detectives convicted and hanged in 1889 So Judy e-mailed Senator Harry Reid asking for information about their great uncle
IN DC ITrsquoS HOW YOU SPIN IT
3
bull Reids staff sent back the following biographical sketch for her genealogy research
Remus Reid was a famous cowboy in the Montana Territory His business empire grew to include acquisition of valuable equestrian assets and intimate dealings with the Montana railroad Beginning in 1883 he devoted several years of his life to government service finally taking leave to resume his dealings with the railroad In 1887 he was a key player in a vital investigation run by the renowned Pinkerton Detective Agency In 1889 Remus passed away during an important civic function held in his honor when the platform upon which he was standing collapsed
IN DC ITrsquoS HOW YOU SPIN IT
4
bull The world of e-commerce bull DSHEA at 23 bull Report card on FDArsquos Office of Dietary Supplement Programs bull What we can expect from FTC post-Ramirez bull Miscellaneous developments bull The elephants in the room bull Takeaways bull QampA
SCOPE OF TODAYrsquoS PRESENTATION
5
DO WE HAVE A LEVEL PLAYING FIELD
6
bull Amazon Estimated Visits 1088000000 UVs 144000000
bull Bodybuildingcom 12500 products Estimated Visits 21000000 UVs 3700000
bull Clickbank Claims 200000000 million customers (supplements = some 10 sales)
bull Costcocom
bull GNCcom Estimated Visits 2000000 UVs 1000000
bull Iherb 35000 products
bull Netritioncom Estimated Visits 160000 UVs 50000
bull Optimum Nutritioncom Estimated Visits 240000 UVs 100000
bull Supplementwarehousecom Selling DMAA Beta alanine sourcing issue
bull Vitacostcom 45000 products
bull VitaminShoppecom Estimated Visits 180000 UVs 30000
THE WORLD OF E-COMMERCE
7
THE WORLD OF E-COMMERCE
8
THE WORLD OF E-COMMERCE
bull Netrush (wwwnetrushcom) presented on Amazon at CRN 2016
bull Netrush is ldquoa leading retailer and agency that partners with brands to grow and manage their products on the Amazon Marketplacerdquo Here is their storefront on Amazon bull (httpswwwamazoncomgpnodeindexhtmlie=UTF8ampmarketplaceI
D=ATVPDKIKX0DERampme=A2G7B63FOSFZJZampmerchant=A2G7B63FOSFZJZampredirect=true)
bull Items are fulfilled by Amazon but sold by Netrush (Netrush may hold inventory at a KY FC and ship to Amazon as quantities deplete)
bull Netrush Director of Strategy Raj Sapru told CRN ldquoThere is Law and then there is Amazon Lawrdquo
bull He added ldquoAmazon doesnrsquot believe in bordersrdquo
9
THE WORLD OF E-COMMERCE
bull Today one can order from 247144 unique dietary supplements available for delivery from Amazon
bull Some have observed what may be contradictions between Amazonrsquos Policy and products available for sale on Amazon labeled as supplements httpswwwnaturalproductsinsidercom~mediaFilesNutritionWhitepapers201703selling-dietary-supplements-on amazonpdf
10
THE WORLD OF E-COMMERCE
bull This link shows Amazonrsquos policy on prohibited listings of supplements httpswwwamazoncomgphelpcustomerdisplayhtmlref=help_search_1-1ie=UTF8ampnodeId=201829030ampqid=1490383280ampsr=1-1
11
THE WORLD OF E-COMMERCE
bull Examples of prohibited listings
bull Homeopathic drugs that are prescription mislabeled or unapproved new drugs
bull httpswwwamazoncomHylands-Calcarea-Sulphurica-Tablets-HomeopathicdpB001E8GGOQref=sr_1_12_a_itie=UTF8ampqid=1490390438ampsr=8-12ampkeywords=homeopathicampth=1
12
THE WORLD OF E-COMMERCE
bull Patches marketed as dietary supplements
bull httpswwwamazoncomPalmetto-Prostate-Transdermal-Patches-SupplydpB013RU7KMKref=sr_1_5_a_itie=UTF8ampqid=1490390665ampsr=8-5ampkeywords=patch+supplement
bull Supplements claiming that they can be used to cure mitigate treat or prevent disease in humans
bull httpswwwamazoncomAyurvedic-Supplement-Formulation-Naturally-SensitivitydpB01LF2FIO4ref=sr_1_21_a_itie=UTF8ampqid=1490390950ampsr=8-21ampkeywords=diabetes+supplement
13
THE WORLD OF E-COMMERCE
bull Sexual enhancement products
bull httpswwwamazoncomAlphaMAN-XL-Sexual-Enhancement-InchesdpB01N0APH2Oref=sr_1_1_a_itie=UTF8ampqid=1490390752ampsr=8-1ampkeywords=penis+growth
bull Supplement listings that include disease names in their keywords
bull httpswwwamazoncomgpsearchref=a9_asi_1rh=i3Aaps2Ck3Ahigh+cholesterol+supplementampkeywords=high+cholesterol+supplementampie=UTF8ampqid=1490391231
14
THE WORLD OF E-COMMERCE
bull Products on USADA list of high-risk supplements such as
bull Driven Sports ndash Craze
bull LG Sciences ndash Formadrol Extreme
bull Isatori Bio-Gro listed as banned by USADA
bull httpswwwamazoncomBio-Gro-Chocolate-Ice-CreamdpB01F1CJ3P4ref=sr_1_5_a_itie=UTF8ampqid=1490391758ampsr=8-5ampkeywords=bio-gro
15
THE WORLD OF E-COMMERCE bull GMP concerns
bull Does Amazon hold supplements in cGMP compliant facilities
bull A number of ds available for sale on Amazonrsquos portal are labeled with the recommendation to store in a cool dry place
bull Here are Fulfillment by Amazon criteria from their website
bull Based on the above requirements it appears Amazon holds some products in temperature-controlled conditions as required by vendors
bull httpswwwamazoncomgphelpcustomerdisplayhtmlref=hp_rel_topicie=UTF8ampnodeId=200339730
bull bull
16
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Reids staff sent back the following biographical sketch for her genealogy research
Remus Reid was a famous cowboy in the Montana Territory His business empire grew to include acquisition of valuable equestrian assets and intimate dealings with the Montana railroad Beginning in 1883 he devoted several years of his life to government service finally taking leave to resume his dealings with the railroad In 1887 he was a key player in a vital investigation run by the renowned Pinkerton Detective Agency In 1889 Remus passed away during an important civic function held in his honor when the platform upon which he was standing collapsed
IN DC ITrsquoS HOW YOU SPIN IT
4
bull The world of e-commerce bull DSHEA at 23 bull Report card on FDArsquos Office of Dietary Supplement Programs bull What we can expect from FTC post-Ramirez bull Miscellaneous developments bull The elephants in the room bull Takeaways bull QampA
SCOPE OF TODAYrsquoS PRESENTATION
5
DO WE HAVE A LEVEL PLAYING FIELD
6
bull Amazon Estimated Visits 1088000000 UVs 144000000
bull Bodybuildingcom 12500 products Estimated Visits 21000000 UVs 3700000
bull Clickbank Claims 200000000 million customers (supplements = some 10 sales)
bull Costcocom
bull GNCcom Estimated Visits 2000000 UVs 1000000
bull Iherb 35000 products
bull Netritioncom Estimated Visits 160000 UVs 50000
bull Optimum Nutritioncom Estimated Visits 240000 UVs 100000
bull Supplementwarehousecom Selling DMAA Beta alanine sourcing issue
bull Vitacostcom 45000 products
bull VitaminShoppecom Estimated Visits 180000 UVs 30000
THE WORLD OF E-COMMERCE
7
THE WORLD OF E-COMMERCE
8
THE WORLD OF E-COMMERCE
bull Netrush (wwwnetrushcom) presented on Amazon at CRN 2016
bull Netrush is ldquoa leading retailer and agency that partners with brands to grow and manage their products on the Amazon Marketplacerdquo Here is their storefront on Amazon bull (httpswwwamazoncomgpnodeindexhtmlie=UTF8ampmarketplaceI
D=ATVPDKIKX0DERampme=A2G7B63FOSFZJZampmerchant=A2G7B63FOSFZJZampredirect=true)
bull Items are fulfilled by Amazon but sold by Netrush (Netrush may hold inventory at a KY FC and ship to Amazon as quantities deplete)
bull Netrush Director of Strategy Raj Sapru told CRN ldquoThere is Law and then there is Amazon Lawrdquo
bull He added ldquoAmazon doesnrsquot believe in bordersrdquo
9
THE WORLD OF E-COMMERCE
bull Today one can order from 247144 unique dietary supplements available for delivery from Amazon
bull Some have observed what may be contradictions between Amazonrsquos Policy and products available for sale on Amazon labeled as supplements httpswwwnaturalproductsinsidercom~mediaFilesNutritionWhitepapers201703selling-dietary-supplements-on amazonpdf
10
THE WORLD OF E-COMMERCE
bull This link shows Amazonrsquos policy on prohibited listings of supplements httpswwwamazoncomgphelpcustomerdisplayhtmlref=help_search_1-1ie=UTF8ampnodeId=201829030ampqid=1490383280ampsr=1-1
11
THE WORLD OF E-COMMERCE
bull Examples of prohibited listings
bull Homeopathic drugs that are prescription mislabeled or unapproved new drugs
bull httpswwwamazoncomHylands-Calcarea-Sulphurica-Tablets-HomeopathicdpB001E8GGOQref=sr_1_12_a_itie=UTF8ampqid=1490390438ampsr=8-12ampkeywords=homeopathicampth=1
12
THE WORLD OF E-COMMERCE
bull Patches marketed as dietary supplements
bull httpswwwamazoncomPalmetto-Prostate-Transdermal-Patches-SupplydpB013RU7KMKref=sr_1_5_a_itie=UTF8ampqid=1490390665ampsr=8-5ampkeywords=patch+supplement
bull Supplements claiming that they can be used to cure mitigate treat or prevent disease in humans
bull httpswwwamazoncomAyurvedic-Supplement-Formulation-Naturally-SensitivitydpB01LF2FIO4ref=sr_1_21_a_itie=UTF8ampqid=1490390950ampsr=8-21ampkeywords=diabetes+supplement
13
THE WORLD OF E-COMMERCE
bull Sexual enhancement products
bull httpswwwamazoncomAlphaMAN-XL-Sexual-Enhancement-InchesdpB01N0APH2Oref=sr_1_1_a_itie=UTF8ampqid=1490390752ampsr=8-1ampkeywords=penis+growth
bull Supplement listings that include disease names in their keywords
bull httpswwwamazoncomgpsearchref=a9_asi_1rh=i3Aaps2Ck3Ahigh+cholesterol+supplementampkeywords=high+cholesterol+supplementampie=UTF8ampqid=1490391231
14
THE WORLD OF E-COMMERCE
bull Products on USADA list of high-risk supplements such as
bull Driven Sports ndash Craze
bull LG Sciences ndash Formadrol Extreme
bull Isatori Bio-Gro listed as banned by USADA
bull httpswwwamazoncomBio-Gro-Chocolate-Ice-CreamdpB01F1CJ3P4ref=sr_1_5_a_itie=UTF8ampqid=1490391758ampsr=8-5ampkeywords=bio-gro
15
THE WORLD OF E-COMMERCE bull GMP concerns
bull Does Amazon hold supplements in cGMP compliant facilities
bull A number of ds available for sale on Amazonrsquos portal are labeled with the recommendation to store in a cool dry place
bull Here are Fulfillment by Amazon criteria from their website
bull Based on the above requirements it appears Amazon holds some products in temperature-controlled conditions as required by vendors
bull httpswwwamazoncomgphelpcustomerdisplayhtmlref=hp_rel_topicie=UTF8ampnodeId=200339730
bull bull
16
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull The world of e-commerce bull DSHEA at 23 bull Report card on FDArsquos Office of Dietary Supplement Programs bull What we can expect from FTC post-Ramirez bull Miscellaneous developments bull The elephants in the room bull Takeaways bull QampA
SCOPE OF TODAYrsquoS PRESENTATION
5
DO WE HAVE A LEVEL PLAYING FIELD
6
bull Amazon Estimated Visits 1088000000 UVs 144000000
bull Bodybuildingcom 12500 products Estimated Visits 21000000 UVs 3700000
bull Clickbank Claims 200000000 million customers (supplements = some 10 sales)
bull Costcocom
bull GNCcom Estimated Visits 2000000 UVs 1000000
bull Iherb 35000 products
bull Netritioncom Estimated Visits 160000 UVs 50000
bull Optimum Nutritioncom Estimated Visits 240000 UVs 100000
bull Supplementwarehousecom Selling DMAA Beta alanine sourcing issue
bull Vitacostcom 45000 products
bull VitaminShoppecom Estimated Visits 180000 UVs 30000
THE WORLD OF E-COMMERCE
7
THE WORLD OF E-COMMERCE
8
THE WORLD OF E-COMMERCE
bull Netrush (wwwnetrushcom) presented on Amazon at CRN 2016
bull Netrush is ldquoa leading retailer and agency that partners with brands to grow and manage their products on the Amazon Marketplacerdquo Here is their storefront on Amazon bull (httpswwwamazoncomgpnodeindexhtmlie=UTF8ampmarketplaceI
D=ATVPDKIKX0DERampme=A2G7B63FOSFZJZampmerchant=A2G7B63FOSFZJZampredirect=true)
bull Items are fulfilled by Amazon but sold by Netrush (Netrush may hold inventory at a KY FC and ship to Amazon as quantities deplete)
bull Netrush Director of Strategy Raj Sapru told CRN ldquoThere is Law and then there is Amazon Lawrdquo
bull He added ldquoAmazon doesnrsquot believe in bordersrdquo
9
THE WORLD OF E-COMMERCE
bull Today one can order from 247144 unique dietary supplements available for delivery from Amazon
bull Some have observed what may be contradictions between Amazonrsquos Policy and products available for sale on Amazon labeled as supplements httpswwwnaturalproductsinsidercom~mediaFilesNutritionWhitepapers201703selling-dietary-supplements-on amazonpdf
10
THE WORLD OF E-COMMERCE
bull This link shows Amazonrsquos policy on prohibited listings of supplements httpswwwamazoncomgphelpcustomerdisplayhtmlref=help_search_1-1ie=UTF8ampnodeId=201829030ampqid=1490383280ampsr=1-1
11
THE WORLD OF E-COMMERCE
bull Examples of prohibited listings
bull Homeopathic drugs that are prescription mislabeled or unapproved new drugs
bull httpswwwamazoncomHylands-Calcarea-Sulphurica-Tablets-HomeopathicdpB001E8GGOQref=sr_1_12_a_itie=UTF8ampqid=1490390438ampsr=8-12ampkeywords=homeopathicampth=1
12
THE WORLD OF E-COMMERCE
bull Patches marketed as dietary supplements
bull httpswwwamazoncomPalmetto-Prostate-Transdermal-Patches-SupplydpB013RU7KMKref=sr_1_5_a_itie=UTF8ampqid=1490390665ampsr=8-5ampkeywords=patch+supplement
bull Supplements claiming that they can be used to cure mitigate treat or prevent disease in humans
bull httpswwwamazoncomAyurvedic-Supplement-Formulation-Naturally-SensitivitydpB01LF2FIO4ref=sr_1_21_a_itie=UTF8ampqid=1490390950ampsr=8-21ampkeywords=diabetes+supplement
13
THE WORLD OF E-COMMERCE
bull Sexual enhancement products
bull httpswwwamazoncomAlphaMAN-XL-Sexual-Enhancement-InchesdpB01N0APH2Oref=sr_1_1_a_itie=UTF8ampqid=1490390752ampsr=8-1ampkeywords=penis+growth
bull Supplement listings that include disease names in their keywords
bull httpswwwamazoncomgpsearchref=a9_asi_1rh=i3Aaps2Ck3Ahigh+cholesterol+supplementampkeywords=high+cholesterol+supplementampie=UTF8ampqid=1490391231
14
THE WORLD OF E-COMMERCE
bull Products on USADA list of high-risk supplements such as
bull Driven Sports ndash Craze
bull LG Sciences ndash Formadrol Extreme
bull Isatori Bio-Gro listed as banned by USADA
bull httpswwwamazoncomBio-Gro-Chocolate-Ice-CreamdpB01F1CJ3P4ref=sr_1_5_a_itie=UTF8ampqid=1490391758ampsr=8-5ampkeywords=bio-gro
15
THE WORLD OF E-COMMERCE bull GMP concerns
bull Does Amazon hold supplements in cGMP compliant facilities
bull A number of ds available for sale on Amazonrsquos portal are labeled with the recommendation to store in a cool dry place
bull Here are Fulfillment by Amazon criteria from their website
bull Based on the above requirements it appears Amazon holds some products in temperature-controlled conditions as required by vendors
bull httpswwwamazoncomgphelpcustomerdisplayhtmlref=hp_rel_topicie=UTF8ampnodeId=200339730
bull bull
16
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
DO WE HAVE A LEVEL PLAYING FIELD
6
bull Amazon Estimated Visits 1088000000 UVs 144000000
bull Bodybuildingcom 12500 products Estimated Visits 21000000 UVs 3700000
bull Clickbank Claims 200000000 million customers (supplements = some 10 sales)
bull Costcocom
bull GNCcom Estimated Visits 2000000 UVs 1000000
bull Iherb 35000 products
bull Netritioncom Estimated Visits 160000 UVs 50000
bull Optimum Nutritioncom Estimated Visits 240000 UVs 100000
bull Supplementwarehousecom Selling DMAA Beta alanine sourcing issue
bull Vitacostcom 45000 products
bull VitaminShoppecom Estimated Visits 180000 UVs 30000
THE WORLD OF E-COMMERCE
7
THE WORLD OF E-COMMERCE
8
THE WORLD OF E-COMMERCE
bull Netrush (wwwnetrushcom) presented on Amazon at CRN 2016
bull Netrush is ldquoa leading retailer and agency that partners with brands to grow and manage their products on the Amazon Marketplacerdquo Here is their storefront on Amazon bull (httpswwwamazoncomgpnodeindexhtmlie=UTF8ampmarketplaceI
D=ATVPDKIKX0DERampme=A2G7B63FOSFZJZampmerchant=A2G7B63FOSFZJZampredirect=true)
bull Items are fulfilled by Amazon but sold by Netrush (Netrush may hold inventory at a KY FC and ship to Amazon as quantities deplete)
bull Netrush Director of Strategy Raj Sapru told CRN ldquoThere is Law and then there is Amazon Lawrdquo
bull He added ldquoAmazon doesnrsquot believe in bordersrdquo
9
THE WORLD OF E-COMMERCE
bull Today one can order from 247144 unique dietary supplements available for delivery from Amazon
bull Some have observed what may be contradictions between Amazonrsquos Policy and products available for sale on Amazon labeled as supplements httpswwwnaturalproductsinsidercom~mediaFilesNutritionWhitepapers201703selling-dietary-supplements-on amazonpdf
10
THE WORLD OF E-COMMERCE
bull This link shows Amazonrsquos policy on prohibited listings of supplements httpswwwamazoncomgphelpcustomerdisplayhtmlref=help_search_1-1ie=UTF8ampnodeId=201829030ampqid=1490383280ampsr=1-1
11
THE WORLD OF E-COMMERCE
bull Examples of prohibited listings
bull Homeopathic drugs that are prescription mislabeled or unapproved new drugs
bull httpswwwamazoncomHylands-Calcarea-Sulphurica-Tablets-HomeopathicdpB001E8GGOQref=sr_1_12_a_itie=UTF8ampqid=1490390438ampsr=8-12ampkeywords=homeopathicampth=1
12
THE WORLD OF E-COMMERCE
bull Patches marketed as dietary supplements
bull httpswwwamazoncomPalmetto-Prostate-Transdermal-Patches-SupplydpB013RU7KMKref=sr_1_5_a_itie=UTF8ampqid=1490390665ampsr=8-5ampkeywords=patch+supplement
bull Supplements claiming that they can be used to cure mitigate treat or prevent disease in humans
bull httpswwwamazoncomAyurvedic-Supplement-Formulation-Naturally-SensitivitydpB01LF2FIO4ref=sr_1_21_a_itie=UTF8ampqid=1490390950ampsr=8-21ampkeywords=diabetes+supplement
13
THE WORLD OF E-COMMERCE
bull Sexual enhancement products
bull httpswwwamazoncomAlphaMAN-XL-Sexual-Enhancement-InchesdpB01N0APH2Oref=sr_1_1_a_itie=UTF8ampqid=1490390752ampsr=8-1ampkeywords=penis+growth
bull Supplement listings that include disease names in their keywords
bull httpswwwamazoncomgpsearchref=a9_asi_1rh=i3Aaps2Ck3Ahigh+cholesterol+supplementampkeywords=high+cholesterol+supplementampie=UTF8ampqid=1490391231
14
THE WORLD OF E-COMMERCE
bull Products on USADA list of high-risk supplements such as
bull Driven Sports ndash Craze
bull LG Sciences ndash Formadrol Extreme
bull Isatori Bio-Gro listed as banned by USADA
bull httpswwwamazoncomBio-Gro-Chocolate-Ice-CreamdpB01F1CJ3P4ref=sr_1_5_a_itie=UTF8ampqid=1490391758ampsr=8-5ampkeywords=bio-gro
15
THE WORLD OF E-COMMERCE bull GMP concerns
bull Does Amazon hold supplements in cGMP compliant facilities
bull A number of ds available for sale on Amazonrsquos portal are labeled with the recommendation to store in a cool dry place
bull Here are Fulfillment by Amazon criteria from their website
bull Based on the above requirements it appears Amazon holds some products in temperature-controlled conditions as required by vendors
bull httpswwwamazoncomgphelpcustomerdisplayhtmlref=hp_rel_topicie=UTF8ampnodeId=200339730
bull bull
16
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Amazon Estimated Visits 1088000000 UVs 144000000
bull Bodybuildingcom 12500 products Estimated Visits 21000000 UVs 3700000
bull Clickbank Claims 200000000 million customers (supplements = some 10 sales)
bull Costcocom
bull GNCcom Estimated Visits 2000000 UVs 1000000
bull Iherb 35000 products
bull Netritioncom Estimated Visits 160000 UVs 50000
bull Optimum Nutritioncom Estimated Visits 240000 UVs 100000
bull Supplementwarehousecom Selling DMAA Beta alanine sourcing issue
bull Vitacostcom 45000 products
bull VitaminShoppecom Estimated Visits 180000 UVs 30000
THE WORLD OF E-COMMERCE
7
THE WORLD OF E-COMMERCE
8
THE WORLD OF E-COMMERCE
bull Netrush (wwwnetrushcom) presented on Amazon at CRN 2016
bull Netrush is ldquoa leading retailer and agency that partners with brands to grow and manage their products on the Amazon Marketplacerdquo Here is their storefront on Amazon bull (httpswwwamazoncomgpnodeindexhtmlie=UTF8ampmarketplaceI
D=ATVPDKIKX0DERampme=A2G7B63FOSFZJZampmerchant=A2G7B63FOSFZJZampredirect=true)
bull Items are fulfilled by Amazon but sold by Netrush (Netrush may hold inventory at a KY FC and ship to Amazon as quantities deplete)
bull Netrush Director of Strategy Raj Sapru told CRN ldquoThere is Law and then there is Amazon Lawrdquo
bull He added ldquoAmazon doesnrsquot believe in bordersrdquo
9
THE WORLD OF E-COMMERCE
bull Today one can order from 247144 unique dietary supplements available for delivery from Amazon
bull Some have observed what may be contradictions between Amazonrsquos Policy and products available for sale on Amazon labeled as supplements httpswwwnaturalproductsinsidercom~mediaFilesNutritionWhitepapers201703selling-dietary-supplements-on amazonpdf
10
THE WORLD OF E-COMMERCE
bull This link shows Amazonrsquos policy on prohibited listings of supplements httpswwwamazoncomgphelpcustomerdisplayhtmlref=help_search_1-1ie=UTF8ampnodeId=201829030ampqid=1490383280ampsr=1-1
11
THE WORLD OF E-COMMERCE
bull Examples of prohibited listings
bull Homeopathic drugs that are prescription mislabeled or unapproved new drugs
bull httpswwwamazoncomHylands-Calcarea-Sulphurica-Tablets-HomeopathicdpB001E8GGOQref=sr_1_12_a_itie=UTF8ampqid=1490390438ampsr=8-12ampkeywords=homeopathicampth=1
12
THE WORLD OF E-COMMERCE
bull Patches marketed as dietary supplements
bull httpswwwamazoncomPalmetto-Prostate-Transdermal-Patches-SupplydpB013RU7KMKref=sr_1_5_a_itie=UTF8ampqid=1490390665ampsr=8-5ampkeywords=patch+supplement
bull Supplements claiming that they can be used to cure mitigate treat or prevent disease in humans
bull httpswwwamazoncomAyurvedic-Supplement-Formulation-Naturally-SensitivitydpB01LF2FIO4ref=sr_1_21_a_itie=UTF8ampqid=1490390950ampsr=8-21ampkeywords=diabetes+supplement
13
THE WORLD OF E-COMMERCE
bull Sexual enhancement products
bull httpswwwamazoncomAlphaMAN-XL-Sexual-Enhancement-InchesdpB01N0APH2Oref=sr_1_1_a_itie=UTF8ampqid=1490390752ampsr=8-1ampkeywords=penis+growth
bull Supplement listings that include disease names in their keywords
bull httpswwwamazoncomgpsearchref=a9_asi_1rh=i3Aaps2Ck3Ahigh+cholesterol+supplementampkeywords=high+cholesterol+supplementampie=UTF8ampqid=1490391231
14
THE WORLD OF E-COMMERCE
bull Products on USADA list of high-risk supplements such as
bull Driven Sports ndash Craze
bull LG Sciences ndash Formadrol Extreme
bull Isatori Bio-Gro listed as banned by USADA
bull httpswwwamazoncomBio-Gro-Chocolate-Ice-CreamdpB01F1CJ3P4ref=sr_1_5_a_itie=UTF8ampqid=1490391758ampsr=8-5ampkeywords=bio-gro
15
THE WORLD OF E-COMMERCE bull GMP concerns
bull Does Amazon hold supplements in cGMP compliant facilities
bull A number of ds available for sale on Amazonrsquos portal are labeled with the recommendation to store in a cool dry place
bull Here are Fulfillment by Amazon criteria from their website
bull Based on the above requirements it appears Amazon holds some products in temperature-controlled conditions as required by vendors
bull httpswwwamazoncomgphelpcustomerdisplayhtmlref=hp_rel_topicie=UTF8ampnodeId=200339730
bull bull
16
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
THE WORLD OF E-COMMERCE
8
THE WORLD OF E-COMMERCE
bull Netrush (wwwnetrushcom) presented on Amazon at CRN 2016
bull Netrush is ldquoa leading retailer and agency that partners with brands to grow and manage their products on the Amazon Marketplacerdquo Here is their storefront on Amazon bull (httpswwwamazoncomgpnodeindexhtmlie=UTF8ampmarketplaceI
D=ATVPDKIKX0DERampme=A2G7B63FOSFZJZampmerchant=A2G7B63FOSFZJZampredirect=true)
bull Items are fulfilled by Amazon but sold by Netrush (Netrush may hold inventory at a KY FC and ship to Amazon as quantities deplete)
bull Netrush Director of Strategy Raj Sapru told CRN ldquoThere is Law and then there is Amazon Lawrdquo
bull He added ldquoAmazon doesnrsquot believe in bordersrdquo
9
THE WORLD OF E-COMMERCE
bull Today one can order from 247144 unique dietary supplements available for delivery from Amazon
bull Some have observed what may be contradictions between Amazonrsquos Policy and products available for sale on Amazon labeled as supplements httpswwwnaturalproductsinsidercom~mediaFilesNutritionWhitepapers201703selling-dietary-supplements-on amazonpdf
10
THE WORLD OF E-COMMERCE
bull This link shows Amazonrsquos policy on prohibited listings of supplements httpswwwamazoncomgphelpcustomerdisplayhtmlref=help_search_1-1ie=UTF8ampnodeId=201829030ampqid=1490383280ampsr=1-1
11
THE WORLD OF E-COMMERCE
bull Examples of prohibited listings
bull Homeopathic drugs that are prescription mislabeled or unapproved new drugs
bull httpswwwamazoncomHylands-Calcarea-Sulphurica-Tablets-HomeopathicdpB001E8GGOQref=sr_1_12_a_itie=UTF8ampqid=1490390438ampsr=8-12ampkeywords=homeopathicampth=1
12
THE WORLD OF E-COMMERCE
bull Patches marketed as dietary supplements
bull httpswwwamazoncomPalmetto-Prostate-Transdermal-Patches-SupplydpB013RU7KMKref=sr_1_5_a_itie=UTF8ampqid=1490390665ampsr=8-5ampkeywords=patch+supplement
bull Supplements claiming that they can be used to cure mitigate treat or prevent disease in humans
bull httpswwwamazoncomAyurvedic-Supplement-Formulation-Naturally-SensitivitydpB01LF2FIO4ref=sr_1_21_a_itie=UTF8ampqid=1490390950ampsr=8-21ampkeywords=diabetes+supplement
13
THE WORLD OF E-COMMERCE
bull Sexual enhancement products
bull httpswwwamazoncomAlphaMAN-XL-Sexual-Enhancement-InchesdpB01N0APH2Oref=sr_1_1_a_itie=UTF8ampqid=1490390752ampsr=8-1ampkeywords=penis+growth
bull Supplement listings that include disease names in their keywords
bull httpswwwamazoncomgpsearchref=a9_asi_1rh=i3Aaps2Ck3Ahigh+cholesterol+supplementampkeywords=high+cholesterol+supplementampie=UTF8ampqid=1490391231
14
THE WORLD OF E-COMMERCE
bull Products on USADA list of high-risk supplements such as
bull Driven Sports ndash Craze
bull LG Sciences ndash Formadrol Extreme
bull Isatori Bio-Gro listed as banned by USADA
bull httpswwwamazoncomBio-Gro-Chocolate-Ice-CreamdpB01F1CJ3P4ref=sr_1_5_a_itie=UTF8ampqid=1490391758ampsr=8-5ampkeywords=bio-gro
15
THE WORLD OF E-COMMERCE bull GMP concerns
bull Does Amazon hold supplements in cGMP compliant facilities
bull A number of ds available for sale on Amazonrsquos portal are labeled with the recommendation to store in a cool dry place
bull Here are Fulfillment by Amazon criteria from their website
bull Based on the above requirements it appears Amazon holds some products in temperature-controlled conditions as required by vendors
bull httpswwwamazoncomgphelpcustomerdisplayhtmlref=hp_rel_topicie=UTF8ampnodeId=200339730
bull bull
16
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
THE WORLD OF E-COMMERCE
bull Netrush (wwwnetrushcom) presented on Amazon at CRN 2016
bull Netrush is ldquoa leading retailer and agency that partners with brands to grow and manage their products on the Amazon Marketplacerdquo Here is their storefront on Amazon bull (httpswwwamazoncomgpnodeindexhtmlie=UTF8ampmarketplaceI
D=ATVPDKIKX0DERampme=A2G7B63FOSFZJZampmerchant=A2G7B63FOSFZJZampredirect=true)
bull Items are fulfilled by Amazon but sold by Netrush (Netrush may hold inventory at a KY FC and ship to Amazon as quantities deplete)
bull Netrush Director of Strategy Raj Sapru told CRN ldquoThere is Law and then there is Amazon Lawrdquo
bull He added ldquoAmazon doesnrsquot believe in bordersrdquo
9
THE WORLD OF E-COMMERCE
bull Today one can order from 247144 unique dietary supplements available for delivery from Amazon
bull Some have observed what may be contradictions between Amazonrsquos Policy and products available for sale on Amazon labeled as supplements httpswwwnaturalproductsinsidercom~mediaFilesNutritionWhitepapers201703selling-dietary-supplements-on amazonpdf
10
THE WORLD OF E-COMMERCE
bull This link shows Amazonrsquos policy on prohibited listings of supplements httpswwwamazoncomgphelpcustomerdisplayhtmlref=help_search_1-1ie=UTF8ampnodeId=201829030ampqid=1490383280ampsr=1-1
11
THE WORLD OF E-COMMERCE
bull Examples of prohibited listings
bull Homeopathic drugs that are prescription mislabeled or unapproved new drugs
bull httpswwwamazoncomHylands-Calcarea-Sulphurica-Tablets-HomeopathicdpB001E8GGOQref=sr_1_12_a_itie=UTF8ampqid=1490390438ampsr=8-12ampkeywords=homeopathicampth=1
12
THE WORLD OF E-COMMERCE
bull Patches marketed as dietary supplements
bull httpswwwamazoncomPalmetto-Prostate-Transdermal-Patches-SupplydpB013RU7KMKref=sr_1_5_a_itie=UTF8ampqid=1490390665ampsr=8-5ampkeywords=patch+supplement
bull Supplements claiming that they can be used to cure mitigate treat or prevent disease in humans
bull httpswwwamazoncomAyurvedic-Supplement-Formulation-Naturally-SensitivitydpB01LF2FIO4ref=sr_1_21_a_itie=UTF8ampqid=1490390950ampsr=8-21ampkeywords=diabetes+supplement
13
THE WORLD OF E-COMMERCE
bull Sexual enhancement products
bull httpswwwamazoncomAlphaMAN-XL-Sexual-Enhancement-InchesdpB01N0APH2Oref=sr_1_1_a_itie=UTF8ampqid=1490390752ampsr=8-1ampkeywords=penis+growth
bull Supplement listings that include disease names in their keywords
bull httpswwwamazoncomgpsearchref=a9_asi_1rh=i3Aaps2Ck3Ahigh+cholesterol+supplementampkeywords=high+cholesterol+supplementampie=UTF8ampqid=1490391231
14
THE WORLD OF E-COMMERCE
bull Products on USADA list of high-risk supplements such as
bull Driven Sports ndash Craze
bull LG Sciences ndash Formadrol Extreme
bull Isatori Bio-Gro listed as banned by USADA
bull httpswwwamazoncomBio-Gro-Chocolate-Ice-CreamdpB01F1CJ3P4ref=sr_1_5_a_itie=UTF8ampqid=1490391758ampsr=8-5ampkeywords=bio-gro
15
THE WORLD OF E-COMMERCE bull GMP concerns
bull Does Amazon hold supplements in cGMP compliant facilities
bull A number of ds available for sale on Amazonrsquos portal are labeled with the recommendation to store in a cool dry place
bull Here are Fulfillment by Amazon criteria from their website
bull Based on the above requirements it appears Amazon holds some products in temperature-controlled conditions as required by vendors
bull httpswwwamazoncomgphelpcustomerdisplayhtmlref=hp_rel_topicie=UTF8ampnodeId=200339730
bull bull
16
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
THE WORLD OF E-COMMERCE
bull Today one can order from 247144 unique dietary supplements available for delivery from Amazon
bull Some have observed what may be contradictions between Amazonrsquos Policy and products available for sale on Amazon labeled as supplements httpswwwnaturalproductsinsidercom~mediaFilesNutritionWhitepapers201703selling-dietary-supplements-on amazonpdf
10
THE WORLD OF E-COMMERCE
bull This link shows Amazonrsquos policy on prohibited listings of supplements httpswwwamazoncomgphelpcustomerdisplayhtmlref=help_search_1-1ie=UTF8ampnodeId=201829030ampqid=1490383280ampsr=1-1
11
THE WORLD OF E-COMMERCE
bull Examples of prohibited listings
bull Homeopathic drugs that are prescription mislabeled or unapproved new drugs
bull httpswwwamazoncomHylands-Calcarea-Sulphurica-Tablets-HomeopathicdpB001E8GGOQref=sr_1_12_a_itie=UTF8ampqid=1490390438ampsr=8-12ampkeywords=homeopathicampth=1
12
THE WORLD OF E-COMMERCE
bull Patches marketed as dietary supplements
bull httpswwwamazoncomPalmetto-Prostate-Transdermal-Patches-SupplydpB013RU7KMKref=sr_1_5_a_itie=UTF8ampqid=1490390665ampsr=8-5ampkeywords=patch+supplement
bull Supplements claiming that they can be used to cure mitigate treat or prevent disease in humans
bull httpswwwamazoncomAyurvedic-Supplement-Formulation-Naturally-SensitivitydpB01LF2FIO4ref=sr_1_21_a_itie=UTF8ampqid=1490390950ampsr=8-21ampkeywords=diabetes+supplement
13
THE WORLD OF E-COMMERCE
bull Sexual enhancement products
bull httpswwwamazoncomAlphaMAN-XL-Sexual-Enhancement-InchesdpB01N0APH2Oref=sr_1_1_a_itie=UTF8ampqid=1490390752ampsr=8-1ampkeywords=penis+growth
bull Supplement listings that include disease names in their keywords
bull httpswwwamazoncomgpsearchref=a9_asi_1rh=i3Aaps2Ck3Ahigh+cholesterol+supplementampkeywords=high+cholesterol+supplementampie=UTF8ampqid=1490391231
14
THE WORLD OF E-COMMERCE
bull Products on USADA list of high-risk supplements such as
bull Driven Sports ndash Craze
bull LG Sciences ndash Formadrol Extreme
bull Isatori Bio-Gro listed as banned by USADA
bull httpswwwamazoncomBio-Gro-Chocolate-Ice-CreamdpB01F1CJ3P4ref=sr_1_5_a_itie=UTF8ampqid=1490391758ampsr=8-5ampkeywords=bio-gro
15
THE WORLD OF E-COMMERCE bull GMP concerns
bull Does Amazon hold supplements in cGMP compliant facilities
bull A number of ds available for sale on Amazonrsquos portal are labeled with the recommendation to store in a cool dry place
bull Here are Fulfillment by Amazon criteria from their website
bull Based on the above requirements it appears Amazon holds some products in temperature-controlled conditions as required by vendors
bull httpswwwamazoncomgphelpcustomerdisplayhtmlref=hp_rel_topicie=UTF8ampnodeId=200339730
bull bull
16
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
THE WORLD OF E-COMMERCE
bull This link shows Amazonrsquos policy on prohibited listings of supplements httpswwwamazoncomgphelpcustomerdisplayhtmlref=help_search_1-1ie=UTF8ampnodeId=201829030ampqid=1490383280ampsr=1-1
11
THE WORLD OF E-COMMERCE
bull Examples of prohibited listings
bull Homeopathic drugs that are prescription mislabeled or unapproved new drugs
bull httpswwwamazoncomHylands-Calcarea-Sulphurica-Tablets-HomeopathicdpB001E8GGOQref=sr_1_12_a_itie=UTF8ampqid=1490390438ampsr=8-12ampkeywords=homeopathicampth=1
12
THE WORLD OF E-COMMERCE
bull Patches marketed as dietary supplements
bull httpswwwamazoncomPalmetto-Prostate-Transdermal-Patches-SupplydpB013RU7KMKref=sr_1_5_a_itie=UTF8ampqid=1490390665ampsr=8-5ampkeywords=patch+supplement
bull Supplements claiming that they can be used to cure mitigate treat or prevent disease in humans
bull httpswwwamazoncomAyurvedic-Supplement-Formulation-Naturally-SensitivitydpB01LF2FIO4ref=sr_1_21_a_itie=UTF8ampqid=1490390950ampsr=8-21ampkeywords=diabetes+supplement
13
THE WORLD OF E-COMMERCE
bull Sexual enhancement products
bull httpswwwamazoncomAlphaMAN-XL-Sexual-Enhancement-InchesdpB01N0APH2Oref=sr_1_1_a_itie=UTF8ampqid=1490390752ampsr=8-1ampkeywords=penis+growth
bull Supplement listings that include disease names in their keywords
bull httpswwwamazoncomgpsearchref=a9_asi_1rh=i3Aaps2Ck3Ahigh+cholesterol+supplementampkeywords=high+cholesterol+supplementampie=UTF8ampqid=1490391231
14
THE WORLD OF E-COMMERCE
bull Products on USADA list of high-risk supplements such as
bull Driven Sports ndash Craze
bull LG Sciences ndash Formadrol Extreme
bull Isatori Bio-Gro listed as banned by USADA
bull httpswwwamazoncomBio-Gro-Chocolate-Ice-CreamdpB01F1CJ3P4ref=sr_1_5_a_itie=UTF8ampqid=1490391758ampsr=8-5ampkeywords=bio-gro
15
THE WORLD OF E-COMMERCE bull GMP concerns
bull Does Amazon hold supplements in cGMP compliant facilities
bull A number of ds available for sale on Amazonrsquos portal are labeled with the recommendation to store in a cool dry place
bull Here are Fulfillment by Amazon criteria from their website
bull Based on the above requirements it appears Amazon holds some products in temperature-controlled conditions as required by vendors
bull httpswwwamazoncomgphelpcustomerdisplayhtmlref=hp_rel_topicie=UTF8ampnodeId=200339730
bull bull
16
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
THE WORLD OF E-COMMERCE
bull Examples of prohibited listings
bull Homeopathic drugs that are prescription mislabeled or unapproved new drugs
bull httpswwwamazoncomHylands-Calcarea-Sulphurica-Tablets-HomeopathicdpB001E8GGOQref=sr_1_12_a_itie=UTF8ampqid=1490390438ampsr=8-12ampkeywords=homeopathicampth=1
12
THE WORLD OF E-COMMERCE
bull Patches marketed as dietary supplements
bull httpswwwamazoncomPalmetto-Prostate-Transdermal-Patches-SupplydpB013RU7KMKref=sr_1_5_a_itie=UTF8ampqid=1490390665ampsr=8-5ampkeywords=patch+supplement
bull Supplements claiming that they can be used to cure mitigate treat or prevent disease in humans
bull httpswwwamazoncomAyurvedic-Supplement-Formulation-Naturally-SensitivitydpB01LF2FIO4ref=sr_1_21_a_itie=UTF8ampqid=1490390950ampsr=8-21ampkeywords=diabetes+supplement
13
THE WORLD OF E-COMMERCE
bull Sexual enhancement products
bull httpswwwamazoncomAlphaMAN-XL-Sexual-Enhancement-InchesdpB01N0APH2Oref=sr_1_1_a_itie=UTF8ampqid=1490390752ampsr=8-1ampkeywords=penis+growth
bull Supplement listings that include disease names in their keywords
bull httpswwwamazoncomgpsearchref=a9_asi_1rh=i3Aaps2Ck3Ahigh+cholesterol+supplementampkeywords=high+cholesterol+supplementampie=UTF8ampqid=1490391231
14
THE WORLD OF E-COMMERCE
bull Products on USADA list of high-risk supplements such as
bull Driven Sports ndash Craze
bull LG Sciences ndash Formadrol Extreme
bull Isatori Bio-Gro listed as banned by USADA
bull httpswwwamazoncomBio-Gro-Chocolate-Ice-CreamdpB01F1CJ3P4ref=sr_1_5_a_itie=UTF8ampqid=1490391758ampsr=8-5ampkeywords=bio-gro
15
THE WORLD OF E-COMMERCE bull GMP concerns
bull Does Amazon hold supplements in cGMP compliant facilities
bull A number of ds available for sale on Amazonrsquos portal are labeled with the recommendation to store in a cool dry place
bull Here are Fulfillment by Amazon criteria from their website
bull Based on the above requirements it appears Amazon holds some products in temperature-controlled conditions as required by vendors
bull httpswwwamazoncomgphelpcustomerdisplayhtmlref=hp_rel_topicie=UTF8ampnodeId=200339730
bull bull
16
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
THE WORLD OF E-COMMERCE
bull Patches marketed as dietary supplements
bull httpswwwamazoncomPalmetto-Prostate-Transdermal-Patches-SupplydpB013RU7KMKref=sr_1_5_a_itie=UTF8ampqid=1490390665ampsr=8-5ampkeywords=patch+supplement
bull Supplements claiming that they can be used to cure mitigate treat or prevent disease in humans
bull httpswwwamazoncomAyurvedic-Supplement-Formulation-Naturally-SensitivitydpB01LF2FIO4ref=sr_1_21_a_itie=UTF8ampqid=1490390950ampsr=8-21ampkeywords=diabetes+supplement
13
THE WORLD OF E-COMMERCE
bull Sexual enhancement products
bull httpswwwamazoncomAlphaMAN-XL-Sexual-Enhancement-InchesdpB01N0APH2Oref=sr_1_1_a_itie=UTF8ampqid=1490390752ampsr=8-1ampkeywords=penis+growth
bull Supplement listings that include disease names in their keywords
bull httpswwwamazoncomgpsearchref=a9_asi_1rh=i3Aaps2Ck3Ahigh+cholesterol+supplementampkeywords=high+cholesterol+supplementampie=UTF8ampqid=1490391231
14
THE WORLD OF E-COMMERCE
bull Products on USADA list of high-risk supplements such as
bull Driven Sports ndash Craze
bull LG Sciences ndash Formadrol Extreme
bull Isatori Bio-Gro listed as banned by USADA
bull httpswwwamazoncomBio-Gro-Chocolate-Ice-CreamdpB01F1CJ3P4ref=sr_1_5_a_itie=UTF8ampqid=1490391758ampsr=8-5ampkeywords=bio-gro
15
THE WORLD OF E-COMMERCE bull GMP concerns
bull Does Amazon hold supplements in cGMP compliant facilities
bull A number of ds available for sale on Amazonrsquos portal are labeled with the recommendation to store in a cool dry place
bull Here are Fulfillment by Amazon criteria from their website
bull Based on the above requirements it appears Amazon holds some products in temperature-controlled conditions as required by vendors
bull httpswwwamazoncomgphelpcustomerdisplayhtmlref=hp_rel_topicie=UTF8ampnodeId=200339730
bull bull
16
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
THE WORLD OF E-COMMERCE
bull Sexual enhancement products
bull httpswwwamazoncomAlphaMAN-XL-Sexual-Enhancement-InchesdpB01N0APH2Oref=sr_1_1_a_itie=UTF8ampqid=1490390752ampsr=8-1ampkeywords=penis+growth
bull Supplement listings that include disease names in their keywords
bull httpswwwamazoncomgpsearchref=a9_asi_1rh=i3Aaps2Ck3Ahigh+cholesterol+supplementampkeywords=high+cholesterol+supplementampie=UTF8ampqid=1490391231
14
THE WORLD OF E-COMMERCE
bull Products on USADA list of high-risk supplements such as
bull Driven Sports ndash Craze
bull LG Sciences ndash Formadrol Extreme
bull Isatori Bio-Gro listed as banned by USADA
bull httpswwwamazoncomBio-Gro-Chocolate-Ice-CreamdpB01F1CJ3P4ref=sr_1_5_a_itie=UTF8ampqid=1490391758ampsr=8-5ampkeywords=bio-gro
15
THE WORLD OF E-COMMERCE bull GMP concerns
bull Does Amazon hold supplements in cGMP compliant facilities
bull A number of ds available for sale on Amazonrsquos portal are labeled with the recommendation to store in a cool dry place
bull Here are Fulfillment by Amazon criteria from their website
bull Based on the above requirements it appears Amazon holds some products in temperature-controlled conditions as required by vendors
bull httpswwwamazoncomgphelpcustomerdisplayhtmlref=hp_rel_topicie=UTF8ampnodeId=200339730
bull bull
16
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
THE WORLD OF E-COMMERCE
bull Products on USADA list of high-risk supplements such as
bull Driven Sports ndash Craze
bull LG Sciences ndash Formadrol Extreme
bull Isatori Bio-Gro listed as banned by USADA
bull httpswwwamazoncomBio-Gro-Chocolate-Ice-CreamdpB01F1CJ3P4ref=sr_1_5_a_itie=UTF8ampqid=1490391758ampsr=8-5ampkeywords=bio-gro
15
THE WORLD OF E-COMMERCE bull GMP concerns
bull Does Amazon hold supplements in cGMP compliant facilities
bull A number of ds available for sale on Amazonrsquos portal are labeled with the recommendation to store in a cool dry place
bull Here are Fulfillment by Amazon criteria from their website
bull Based on the above requirements it appears Amazon holds some products in temperature-controlled conditions as required by vendors
bull httpswwwamazoncomgphelpcustomerdisplayhtmlref=hp_rel_topicie=UTF8ampnodeId=200339730
bull bull
16
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
THE WORLD OF E-COMMERCE bull GMP concerns
bull Does Amazon hold supplements in cGMP compliant facilities
bull A number of ds available for sale on Amazonrsquos portal are labeled with the recommendation to store in a cool dry place
bull Here are Fulfillment by Amazon criteria from their website
bull Based on the above requirements it appears Amazon holds some products in temperature-controlled conditions as required by vendors
bull httpswwwamazoncomgphelpcustomerdisplayhtmlref=hp_rel_topicie=UTF8ampnodeId=200339730
bull bull
16
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
THE WORLD OF E-COMMERCE
bull Other concerns with e-tailers (contrsquod)
bull Some have not registerednotified their private label products in export markets bull Some have not notified FDA of supplements bearing structurefunction claims bull Some are not taking steps to comply with FSMA bull Many do not have adequate systems for post-marketing surveillance and AE
assessment nor are they reporting SAEs bull Some havenrsquot registered their facilities consistent with 2002 Bioterrorism Act bull Some have not conducted cGMP audits of manufacturing facilities bull Many do not have thermal controlled product holding facilities bull Some do not have adequate SOPs nor do they regularly train against SOPs bull Most do not conduct analytical testing to affirm stability safety label claims bull Most do not possess CARSE to support claims
17
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
THE WORLD OF E-COMMERCE
bull What Vitalize LLC does (holding company for BBCom)
bull 12500 SKUs (mostly third-party products) bull Review ingredients claims labels bull Review formulae against proprietary banned ingredients list bull Review claims against internal list of banned wordsclaims bull Ship via personal consignment from cGMP compliantaudited facilities bull QA receives and evaluates product complaints and AEs submits SAEs bull For proprietary private label products
bull Audits contract manufacturers bull Conduct rigorous testing bull Prepare formula-specific claim substantiation files bull Notify FDA of structurefunction claims
18
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
THE WORLD OF E-COMMERCE
bull FDArsquos approach to E-commerce
bull FDA is fully prepared to receive and evaluate expressions of concern involving Amazon or others but given bandwidth FDA is presently focused on issues involving threats to public health
bull Failures to comply with DSHEA the FFDCA and implementing regulations may not necessarily result in enforcement actions
bull This places companies that invest in compliance at an economic disadvantage
19
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Unanimously passed Congress Fall 1994
bull Only one of original legislative champions ndash Senator Orrin Hatch (R-UT) ndash remains will he will run again
bull More recent legislative champion ndash Cong Jason Chaffetz (R-UT) co-chair of the Dietary Supplement Caucus ndash will leave Congress this Summer
bull Chaffetz sponsored ldquoFree Speech About Science Actrdquo
bull DSC co-chair Jared Polis (D-CO) may run for Governor
bull Industry consensus DSHEA works FDA needs to fully enforce DSHEA but lacks adequate resources (26 FTEs)
DSHEA AT 23
20
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Who is this man and why should we care
DSHEA AT 23
21
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Now that Dr Scott Gottlieb has been confirmed as FDA Commissioner how may he impact our industry bull Cancer survivor professor at NYU School of Medicine
bull Two prior senior positions within commissionerrsquos office at FDA
bull Supports limited regulation to promote health care innovation
bull When he was at FDA Congress passed 2006 law mandating submission of SAEs and he was at FDA as industry worked with the Agency to promulgate cGMP final rule in 2007
bull Dr Gottliebrsquos statements align with the Administrationrsquos view (less burdensome regs) is he open to modifying FDArsquos recent draft guidances
bull During Senate debate Sen Durbin called on FDA to increase its regulatory vigilance over our industry
DSHEA AT 23
22
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Herersquos what Dr Gottlieb said April 5 during his confirmation hearing in response to a question from Senator Hatch
bull ldquoAs someone who uses dietary supplements every day I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products I believe the regulatory framework established under DSHEA is the right one and if confirmed I would commit to enforcing DSHEA as intended by Congressrdquo
DSHEA AT 23
23
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Launch of industry-wide Online Wellness Library bull Supported by ABC AHPA CRN NPA and Tom Aarts of NBJ
bull Some 30 CRN members including Vitalize have loaded labels (some 60 CRN members have finished products in the marketplace)
bull Nearly 2600 labels included at launch almost 500 added in first week
bull As Dan Fabricant said ldquoThis is another example of the industry working together to give consumers what they deserve confidence to know the products they take each and every day are safe and beneficial As part of our commitment to supporting the suppliers manufacturers consumers and regulators of the natural products industry NPA offers our full support for this new and exciting initiativerdquo
DSHEA AT 23
24
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull FDArsquos NDI Recent Statistics
bull Number of ldquoacknowledgement with no objectionrdquo letters (AKL) FDA has sent for NDI notifications has increased past two years
bull ODSP is not necessarily seeing a high number of acknowledgement lettersrdquo from FY lsquo14 lsquo15 and lsquo16 ldquobut maybe beginning of a trend
bull An AKL letter is FDAs most positive response for an NDI notification FDA has no questions on the submissions data the NDI is safe for intended use
bull ODSP sent four AKL to firms in FY lsquo14 slightly more in FY lsquo15 and 10-15 in FY rsquo16 FDA sent more NDI notification rejections overall as around 25 of notifications resulted in an AKL Between 40 and 50 notifications are submitted a year for a total of about 1000 over the past 20 years
DSHEA AT 23
25
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull FDArsquos New Dietary Ingredient Revised Draft Guidance bull FDA should clarify the parameters of the NDI Master File concept to
make the NDI notification requirement efficient
bull FDA should not require a NDI notification for each combination of already notified NDIs
bull FDA should clarify the process for working with industry to establish an authoritative list of grandfathered ingredients (within 20-24 months) and should not illegitimately limit the scope of such ingredients
bull FDA must not retroactively apply DSHEArsquos definition of ldquodietary ingredientrdquo
bull Manufacturing changes do not transform a grandfathered ingredient into an NDI
DSHEA AT 23
26
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull FDArsquos New Dietary Ingredient Revised Draft Guidance (contrsquod) bull FDA should include ldquoGRAS self-affirmationsrdquo as a potential exemption to
the NDI notification requirement
bull FDA should clarify that GRAS self-affirmations for previously rejected NDI notifications eliminate the need for further NDI notification
bull FDA should acknowledge that synthetics are dietary ingredients
bull FDA should work with industry to ensure dietary supplement safety
bull FDA should utilize DSHEArsquos broad safety standards to take action against outliers
bull FDA should post redacted summaries of serious adverse events
bull
DSHEA AT 23
27
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Industry engaged bull On Capitol Hill NPA pressed Congress to make supplements eligible for
reimbursement under FSAsHSAs to include multivitamins under the WIC program to make supplements eligible for coverage under SNAP program and to support revisions to FDArsquos NDI revised draft guidance
DSHEA AT 23
28
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Scientific information on diet and health has improved including link between diet composition and risk of chronic diseases and public health
bull Amount of foods consumed has changed and FDArsquos reference amounts customarily consumed used to set serving sizes needed adjustment
bull Priorities for dietary guidance changed with focus shifting to calories and serving sizes as two important elements to help consumers make healthier choices
DSHEA AT 23
29
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull FDArsquos revisions to Facts panel labels (contrsquod)
bull Two proposed rules issued March 2014
bull Supplemental proposed rule issued July 2015
bull Two final rules published on May 27 2016
ndashRevision of the Nutrition and Supplement Facts Labels
ndashRevision of Serving Size Requirements
DSHEA AT 23
30
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Modernized the format to highlight calories and serving size information updated footnote
bull Updated the Daily Values (DVrsquos)
bull Mandated declaration of added sugars with DV
bull Updated nutrients of public health significance
bull Transfat and dietary fiber
bull Included records requirements
DSHEA AT 23
31
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull FDArsquos revisions to Facts panel labels added sugars (contrsquod)
bull Based on evidence that
minusHigh intake of added sugars decreases intake of nutrient dense foods and increases overall caloric intake
minusDietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease
-- Daily Value
minusMeeting nutrient needs while staying within calorie limits is difficult with more than 10 percent of total daily calories from added sugar
DSHEA AT 23
32
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull FDArsquos revisions to Facts panel labels key changes (contrsquod)
bull Changed some reference amounts used to calculate serving sizes
bull Required dual-column labeling with nutrition information listed per serving and per package or unit for certain products
bull Changed the criteria for single serving packages
bull Compliance date
DSHEA AT 23
33
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull FDArsquos revisions to Facts panel labels (contrsquod) bull FDA has gotten rid of calories from fat based on research indicating that
the type of fat is more important than the amount
bull FDA has instituted record keeping requirements to establish the accuracy of stated nutrient amounts for dietary fiber soluble fiber insoluble fiber added sugars and folic acid
bull The presence of ldquoadded sugarsrdquo is one of the most prominent changes and will likely generate much attention from label reviewers important to understand this section carefully to verify the definition and any applicable exemptions
DSHEA AT 23
34
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull FDArsquos proposed revisions to Facts panel labels (contrsquod) bull Vitamin C and Vitamin A have been ldquodemotedrdquo based on research that
deficiencies in these vitamins are rare while Vitamin D and Potassium have been given more prominence quantitative amounts must be displayed as they are for dietary supplements
bull Changes in some RDIs could have a significant effect on nutrient content claims depending on how close nutrients are to current thresholds
bull FDA is still shooting for industry compliance by July 2018 though Commissioner-designate Dr Gottlieb is open to a compliance delay
DSHEA AT 23
35
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
36
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull FDArsquos proposed revisions to Facts panel labels (contrsquod)
DSHEA AT 23
bull CSPI says ldquoBig Foodrdquo doesnrsquot want you to know how much added sugar is in your packaged foodsmdashat least for another four years
bull GMA asked HHSrsquo Price to delay implementation until May 2021
bull FDA Commissioner Designate Gottlieb would favor delay ldquoto line up with whenever the US Department of Agriculturersquos upcoming rule requiring disclosure of ingredients from GM crops
37
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull FDArsquos Food Facility Registration Database bull In its latest cleanup of the database FDA culled 28 of registrations
bull Highest percentage of eliminations occurred overseas
bull Represents a doubling of the reductions since culling last done in 2014
bull That may have resulted from evolving US regulations
bull A US-based agent for a foreign firm must now affirmatively respond to FDA it is acting in that capacity and accepts the liability
bull China experienced 46 drop India 44 Mexico 53 in facility registrations with FDA
DSHEA AT 23
38
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Supplement Safety Compliance Initiative bull SSCI focuses on the entire product life cycle and welcomes all owners and
certifying bodies to participate in future benchmarking
bull Similar retailer driven initiatives have been developed for foods but never applied to dietary supplements until now ldquoSSCI will continue to promote safety and consumer confidence in each step of the supply chain from farm to store shelfrdquo added Dr Fabricant
bull SSCI will set out to accomplish the following goals
bull Reduce supplement safety risks recalls and harms by delivering equivalence and convergence between effective supplement safety management systems
bull Develop core competencies and capacity building in supplement safety to create effective global systems
DSHEA AT 23
39
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Supplement Safety Compliance Initiative (contrsquod) bull Drive global change through benchmarking of all standards domestic
and international
bull Provide a unique stakeholder platform for collaboration knowledge sharing and networking
bull Manage costs by eliminating redundancy in certification and improving operational efficiency
bull Increase the number of qualified auditors available to manufacturers further increasing consumer safety
bull GNC Vitamin Shoppe Walmart Whole Foods and others onboard
DSHEA AT 23
40
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Supplement Safety Compliance Initiative (contrsquod) bull Address the myriad of standards available globally by allowing various
schemes in the international community to benchmark their standard to one overarching standard
bull Design a tiered structure that accommodates the unique needs of small ingredient suppliers (ie organic wild-crafted herbs) manufacturers and retailers
DSHEA AT 23
41
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Global Retail Manufacturing Alliance bull NSF International plus major retailers and manufacturers created the
Global Retailer and Manufacturer Alliance (GRMA) to develop consensus-based standards for dietary supplements cosmeticspersonal care products over-the-counter (OTC) drugs and medical devices
bull Combining retailer and regulatory requirements into a single standard and auditing program for each product category will help reduce audits and costs while strengthening safety quality and trust throughout the supply chain
DSHEA AT 23
42
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials bull GACP-GMP guidance document serves as a template that growers harvesters
and processors can adapt to the scope and needs of their operations
bull Ensure herbal raw materials used in consumer products are accurately identified
bull Conformance to all quality characteristics for which they are represented and
bull Avoid adulteration with contaminants that may present a public health risk
bull Promotes awareness of supply chain practices that support compliance with regulatory GMPs for finished products
bull Addresses both wild-harvested and cultivated plant material
bull Can be used by multiple industries that utilize botanical material ndash dietary supplements as well as food drugs cosmetics biofuels etc
DSHEA AT 23
43
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull AHPA Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (contrsquod)
bull Companion assessment program under development
bull Provide direction on sections of the document relevant to specific categories of botanical operations
bull Wild-harvesters
bull Cultivators
bull Botanical ingredient suppliers
bull Advanced processorsextract manufacturers
bull Creating forms for use in self-assessment and documentation of compliance to specifications in support of buyer-seller relationships
DSHEA AT 23
44
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Retailer-specific initiatives CVS last month new testing standards for VMS to be implemented 2019
Standards will require third-party testing of ingredient listings for VMS as well as product testing for ingredients of concern
CVS to focus on VMS supplements targeted for weight control protein powders energy shots and energy powders
CVS initiative involves 100+ suppliers producing gt 800 products
GNC previously initiated similar initiatives
Whole Foods initiative (free of artificial colors flavors sweeteners hydrogenated oils and prohibited ingredients)
DSHEA AT 23
45
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
46
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP Openness to meeting with and working with industry other stakeholders
Effective at protecting public health
Effective at fully implementing and enforcing DSHEA and other laws
Efficient at reviewing and acting on NDI submissions
Effective at ensuring industry cGMP compliance
Effective at ensuring meaningful post-marketing surveillance
Effective at ensuring a level regulatory compliance playing field
Efficient at promulgating fair and clear guidance to stakeholders
Effective at taking action to preclude outliers from continuing to do business
Supports science-based claims backed by CARSE
47
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Openness to meeting with and working with industry A+
48
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A
Beware of products claiming to cure cancer on websites or social media platforms such as Facebook and Instagram Nicole Kornspan MPH a consumer safety officer at the US Food and Drug Administration (FDA) says theyrsquore rampant 14 warning letters issued April 25
49
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull An April 18 FDA issued an alert update about a Chinese firm distributing
HGH-containing supplements
bull This followed publication of an alert in September and an update in November about other firms in the country reported as shipping supplements tainted with the ingredient
bull HGH use comes with risks of long-term side effects including increased risk of cancer and other problems including nerve pain and elevated cholesterol and glucose levels
50
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Effective at protecting public health A (contrsquod) bull Other Ingredients of concern On 421 FDA asked for input as to which
ingredients in commercial products pose risk to public health that should become enforcement priorities
51
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B FSMA
bull FSMArsquos preventive controls rule 21 CFR 1175(e) exempts finished dietary supplements from requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111
bull However exemption from these two aspects of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA
bull FSMA directly affects dietary ingredient manufacturers
bull Only finished DS products exempted from subparts C and G or Part 117
bull Facilities making dietary ingredients must comply with the revised cGMPs but must also implement preventive controls and a supply-chain program
52
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Effective at fully implementingenforcing DSHEA other laws B bull Kratom import detention alert (gt106 firmsproducts listed since 214
bull FDA says NDIN needed (no complete NDINs submitted)
bull Seizures of dietary supplements and unapproved new drugs
bull Vinpocetine
bull FDA is of the view it does not meet definition of dietary ingredient and is excluded from definition of dietary supplement
bull FDA received gt 800 comments
53
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Effective at reviewing and acting on NDI submissions B FDArsquos Dr Ali Abdel-Raman supervisory toxicologist at CFSAN open to
pre-filing discussions On 5917 Dr Abdel-Raman told an AHPA NDI webinar
bull ldquoFDA considers 25 years of widespread use to be the minimum to establish a history of safe userdquo
25 years ago if the ingredient was used it would be pre-DSHEA No drug or other consumer product held to this unrealistic standard FDA has not properly qualified definition of safety of new dietary
ingredients May a dietary ingredient be synthetically produced About 30 of NDIs get through NDI draft guidance makes reference to Red Book which was developed
for direct food additives and food ingredients
54
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A bull Per AHPA statistics received from FDA regarding dietary supplement
facility inspections from 12010 -122016
bull 1808 unique dietary supplement facilities inspected (including international inspections)
bull 2421 total inspections (includes re-inspections)
bull 737 of 1808 (41) most recent unique inspections resulted in no FDA Form 483
bull 1071 inspections (59) resulted in an FDA Form 483
55
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance A FDA issued 15 pharma GMP-related warning letters in lsquo16 to Chinese
manufacturing sites in China ndash 5-fold increase from prior years
China averaged 27 WLsyear from lsquo13-15 This is part of the on-going trend of increased international inspection activity
FDA inspected 41 Indian facilities 912 through 1214 leading to 17 warning letters
Chinese and Indian companies have several issues but the primary area of concern appears to be data integrity
56
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Effective at ensuring industry cGMP compliance B+ (contrsquod) Indian firms have become much more ldquosophisticatedrdquo how they hide
manipulate and destroy manufacturing data
Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root) instead of learning how better to mask them
The majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night andor their ldquosample testingrdquo are rigged to pass because the ldquorightrdquo sample is tested
57
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B Did FDA over-reached when on 117 it revised its website saying AEs associated with these conditions should be submitted as SAEs
bull Itching rash hives throatliptongue swelling wheezing
bull Low blood pressure fainting chest pain shortness of breath palpitations irregular heart beat
bull Severe persistent nausea vomiting diarrhea or abdominal pain
bull Difficulty urinating decreased urination
bull Fatigue appetite loss yellowing skineyes itching dark urine
bull Severe jointmuscle pain
bull Slurred speech one-sided weakness of face arm leg vision (stroke)
bull Abnormal bleeding from nose or gums
bull Blood in urine stool vomit or sputum
bull Marked mood cognitive or behavioral changes thoughts of suicide
bull Visit to Emergency Room or hospitalization
58
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Effective ensuring meaningful post-marketing surveillance B During 1216 FDA unveiled important capacity to mine CAERS data
httpswwwfdagovfoodcomplianceenforcementucm494015htm
Many companies do not have adequate system to receive evaluate and resolve product complaints adverse events or to report and update serious adverse events
Particularly acute for e-tailers and sports nutrition companies
TBOMK FDA has not cross-referenced companies with notified products or registered facilities to see if they have or have not submitted SAEs
59
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B- Le-Vel and others marketing weight loss patches
ODSP says it lacks band-width (eg resources only 26 FTEs) to ensure level enforcement playing field
Appropriations for CFSAN that oversees dietary supplements and houses the Office of Cosmetics and Colors total roughly $103bn up $382m from the sum in the FY 2016 legislation
Current ODSP priorities per Steve Tave 510 (1) safety precluding marketing of ingredients or finished ds posing potential risks to public health (2) product integrity (cGMP compliance) and (3) informed decision-making
60
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Effective ensuring a level regulatory compliance playing field B-
61
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B Like FDAs draft guidance on new dietary ingredient notifications and its
previous estimates for compliance with that regulation and the GMP final rule the agencys notice published 420 its assessment as to industrylsquos annual burdens for GMP recordkeeping prompted industry questions
ldquoThe supplement industry spends up to $1bn each year complying with federal regulationsrdquo
NPA AHPA CRN and UNPA agree FDArsquos recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately
62
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation of fair clear guidance to stakeholders B FDAs cost-impact estimate may not include supporting documents
required for evaluation of finished products which begins with a master manufacturing record and a batch record (time needed to write implement and maintain a document control system is significant)
The notice lists requirements for establishing written procedures and maintaining records which must be provided to FDA officials on request for areas including personnel laboratory manufacturing packaging and labeling and holding and distributing operations returned supplements and product complaints
63
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Efficient promulgation fair clear guidance to stakeholders B FDA unlikely to issue a revised or final NDI guidance this year
Though receptive to a ldquoMaster Filerdquo concept JV first espoused (while at HLF) no legal framework exists for applying it to dietary ingredients
FDA open to working with industry to develop suitable legal framework medical ldquoMaster Filerdquo approach not be suitable for dietary ingredients per FDA 421
64
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Effective taking action to preclude outliers from doing business C A significant number of companies Make inappropriate claims Have not notified FDA of product labels bearing of SF claims within 30
days of entering commerce as required by 21 CFR 403(R)(6) Have not conducted cGMP audits of manufacturing facilities Do not have adequate SOPs nor do they regularly train against SOPs Do not conduct analytical testing to affirm stability safety label claims Do not possess CARSE to support claims Do not have thermal controlled product holding facilities Do not have validated systems to receive assess report consumer
complaints or AEs or a SOP for conducting material reviews
65
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull On 426 AHPA submitted comments encouraging FDA to expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans AHPA also encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDAs current policy to exercise enforcement discretion until the current healthy regulation is updated
bull FDA exercising enforcement discretion depending on source of fats
Definition of lsquodietary fiberrsquo
66
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull In its guidance FDA asked industry for comment on points including ldquowhat types of food if any should be allowed to bear the term ldquohealthyrdquo whether all food categories should be subject to the same criteria whether the nutrients be introduced to foods or should they be provided in part or in total by fortification
bull FDA also asked ldquoIf nutrients for which intake is encouraged are included in the definition should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population or should they include those nutrients that contribute to general overall healthrdquo
bull The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including ldquohealthyrdquo or related terms such as ldquohealthrdquo ldquohealthfulrdquo ldquohealthfullyrdquo ldquohealthfulnessrdquo healthiesrdquo and others Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient such as ldquohealthy contains 2 grams of fatrdquo
67
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
REPORT CARD ON FDArsquoS ODSP
Supports science-based claims backed by CARSE Incomplete Definition of lsquohealthyrsquo
bull The nutrient conditions for bearing a ldquohealthyrdquo nutrient content claim include specific criteria for nutrients to limit in the diet such as total fat saturated fat cholesterol sodium and other requirements for nutrients to include in the diet such as vitamin C iron and protein
bull In an April 20 blog post CFSAN Director Susan Mayne acknowledged that nutrition science has evolved
bull ldquoWhereas in the past we placed greater emphasis on total fat we now know that not all fats are alike and some are better for health than others And while the focus on ensuring that people are getting the right amounts of different nutrients still matters other things matter as well such as food groups or the combinations of different foods or beverages in the diet Mayne said
68
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Naming permanent team at FTC
WHAT CAN WE EXPECT FROM FTC
69
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Possible revisions to FTCrsquos Advertising Guidance for Industry bull Industry does not recommend substantial changes to the core document
available for 16 years industry CRN supports the flexible standard
bull Ensure references to claims and examples are not disease claims and that the terminology is consistent with what is allowed by FDA
bull Include statement FDA prohibits disease claims without a discussion or further elaboration regarding the substantiation for such claims
bull Include references to existing relevant FTC guidance including FTCrsquos Endorsement and Testimonial Guide Native Advertising Guide etc
bull Include a visual example of clear and prominent disclosure
bull Elaborate on acceptability of ldquoTotality of Evidencerdquo
bull Elaborate on what is met by consumersrsquo ldquonet impressionrdquo and FTCrsquos expectations
WHAT CAN WE EXPECT FROM FTC
70
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Endorsements and testimonials bull GNC has been and appears to be continuing to pay retail clerks bonus
commissions or promotional money when clerks direct customers to certain higher-margin products
bull Commissions are not disclosed and may potentially be in violation of FTCrsquos guidance on endorsements and testimonials in advertising
bull httpswwwftcgovsitesdefaultfilesattachmentspress-releasesftc-publishes-final-guides-governing-endorsements-testimonials091005revisedendorsementguidespdf
WHAT CAN WE EXPECT FROM FTC
71
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Endorsements and testimonials (contrsquod) bull As part of an agreement the DOJ GNC agreed to voluntarily work to
develop an industry-wide quality seal program When this quality seal is implemented GNC has agreed to stop paying its retail salespeople bonus commissions or ldquopromotional moneyrdquo to direct customers to products in its stores not carrying the seal httpswwwjusticegovopaprgnc-enters-agreement-department-justice-improve-its-practices-and-keep-potentially-illegal
bull Some suggest GNCrsquos current practices ndash which Vitamin Shoppe reportedly does not replicate ndash may violate Section 5 of the FTC Act
WHAT CAN WE EXPECT FROM FTC
72
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Influencers bull Disclosures from social-media influencers about brand relationships are
likely not sufficient if theyrsquore buried in posts below the ldquomorerdquo button that consumers on mobile devices often do not click
bull FTC offers that rule of thumb and more in a barrage of ldquoreminderrdquo letters and related communications issued April 19
bull Expect enforcement action
WHAT CAN WE EXPECT FROM FTC
73
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Fake News
WHAT CAN WE EXPECT FROM FTC
74
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Fake News
bull An article April 6 began with a shocking revelation ldquoStephen Hawking credits his ability to function and maintain focus on such a high level to a certain set of lsquosmart drugsrsquo that enhance cognitive brain function and neural connectivity while strengthening the prefrontal cortex and boosting memory recallrdquo The URL was socialaffluentcom
WHAT CAN WE EXPECT FROM FTC
75
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Fake News (contrsquod) bull Hawking said that his brain is sharper than ever more clear and focused
and he credits a large part to using Synagen IQrdquo it read ldquoHawking went on to add lsquoThe brain is like a muscle you got to work it out and use supplements just like body builders use but for your brain and thatrsquos exactly what Irsquove been doing to enhance my mental capabilitiesrsquordquo
bull Hawking of course did not say this to Cooper The whole thing is fiction Except for the product itself
WHAT CAN WE EXPECT FROM FTC
76
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Data Privacy bull FTC has become increasingly active with regards to data security
bull FTC will now consider that failure to follow corporate policies to protect consumer data can constitute unfair or deceptive acts since consumers can be presumed to rely on the privacy policies posted on corporate websites
bull An example $100 million settlement with LifeLock Inc due to the companyrsquos data security practices including ldquofailure to establish and maintain a comprehensive information security program to protect usersrsquo sensitive personal informationrdquo as well as the false advertisement of the companyrsquos level of data security
WHAT CAN WE EXPECT FROM FTC
77
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Recent enforcement actions
bull Kudos to Bayer
bull Last month a judge lsquoquicklyrsquo dismissed a class action suit against Bayer alleging unsubstantiated claims for its Phillips Colon Health Probiotic Supplement
bull Plaintiffs failed to produce competent evidence to create a genuine issue of material fact that Bayerrsquos PCH promotes overall digestive health and helps to defend against occasional constipation diarrhea gas and bloating were actually false and misleading
bull Industry remains concerned by FTCrsquos continued willingness to apply 2 RCT standard
WHAT CAN WE EXPECT FROM FTC
78
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
bull Recent enforcement actions (contrsquod)
bull Marketers of lsquoNutriMost Ultimate Fat Loss Systemrsquo Settle FTC Charges
bull Marketers of weight-loss system advertised using ldquobreakthrough technologyrdquo and ldquopersonalized supplementsrdquo to help consumers permanently lose ldquo20 to 40+ pounds in 40 daysrdquo without significantly cutting calories agreed to settle a FTC complaint that the claims were deceptive and not supported by scientific evidence
bull The court order settling the FTCrsquos charges bars the sellers of the ldquoNutriMost Ultimate Fat Loss Systemrdquo from making the deceptive claims alleged in the complaint as well as providing others including franchisees with the means of deceiving consumers Defendants also will pay $2 million to provide refunds to consumers defrauded by buying the system directly from the defendants not from franchisees
WHAT CAN WE EXPECT FROM FTC
79
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
MISCELLANEOUS bull Prop 65
bull AHPA submitted comments to the OEHHA relative to its request for relevant information on the carcinogenic hazards of the chemical coumarin (CAS No 91-64-5)
bull OEHHA selected coumarin for review by the Carcinogen Identification Committee (CIC) of OEHHAs Scientific Advisory Board for possible listing under Proposition 65 as a chemical known to the State of California to cause cancer
80
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
MISCELLANEOUS bull Prop 65 (contrsquod)
bull AHPA asked that all future OEHHA communications clearly state this fact and provide a representative list of these plants which include lavender oil (Lavandula angustifolia syn L officinalis) some species of cinnamon such as Cinnamomum cassia and sweet woodruff (Galium odoratum syn Asperula odorata)
81
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
MISCELLANEOUS bull Biotin Class Action
bull CRN learned of a class action complaint alleging health benefit claims for a biotin supplement were fraudulent under CArsquos Unfair Competition Act and Consumers Legal Remedy Act as the general population receives more than adequate amounts of biotin from the diet and the body only uses a finite amount of this nutrient therefore any amounts beyond that are ldquosuperfluousrdquo and do not provide any health benefits
bull Plaintiff cites IOMrsquos adequate intake (AI) for biotin (30 mcgday) stating only those with rare biotin deficiency conditions would benefit from biotin supplementation
bull Rather than targeting the efficacy or safety of the product plaintiff argues that supplementation above the AI level is unnecessary so any health benefit claims are false and deceptive
82
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
HOW TO ADDRESS ELEPHANTS IN THE ROOM
83
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
HOW TO ADDRESS ELEPHANTS IN THE ROOM
84
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case Hi-Tech says the Courtrsquos holding was erroneous and should be vacated for two reasons bull There is no requirement under DSHEA that a substance only qualifies as
dietary ingredient if it can be extracted in ldquousable quantitiesrdquo DSHEA states that the ldquoconstituentsrdquo of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical The Government agreed with this interpretation of DSHEA
bull The Court entered summary judgment resolving a factual issuendashndash whether DMAA can be extracted from geraniums in ldquousable quantitiesrdquondashndashbased on an incomplete record
85
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull This finding ignored certain evidence in the record which Claimants are
entitled to supplement regarding the ability to extract DMAA from geraniums in ldquousable quantitiesrdquo The Court committed an error by relying on this incomplete factual record to grant summary judgment Hi-Tech appealed asking that the April 3 Order should be vacated on this basis as well and the judgment and order should be vacated
86
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) bull The Court rejected the Governmentrsquos three main critiques of scientific papers failing to
detect DMAA explaining (1) the papers cited by the Government that did not detect DMAA ldquomay not have been suitable for [detection] of DMAA due to its volatilityrdquo (2) Dr Paula Brownrsquos testimony regarding the ability of geraniums to produce DMAA was not ldquounequivocalrdquo and did not provide anything ldquoclose to uncontroverted evidence that geraniums cannot make DMAArdquo and (3) the Governmentrsquos claims that DMAA detected in geraniums was the result of contamination ldquofail[ed] to address the fact that other studies did find DMAArdquoId at 5-6 As such the Court was ldquounswayed by the Governmentrsquos argument that it is impossible for the geranium in question to synthesize DMAArdquo and concluded that ldquothe question as presented by the parties is whether DMAA has been detected in geraniums not how the geraniums happened to put the chemical there this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniumsrdquo Id at 6-7
87
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
HOW TO ADDRESS ELEPHANTS IN THE ROOM
Hi-Tech DMAA case (contrsquod) Hi-Tech Pharmaceuticals creates manufactures and sells products sold by large major retailers including Amazon GNC Rite Aid Vitamin Shoppe Vitamin World KMart Albertsons CVS Meijer Hannaford Cardinal Health McKesson Mclain Harmon Stores Winn-Dixie Supervalu Roundys Sav-On Drugs Fruth Pharmacy and over 5000 independent drug stores as well as 80000 convenience stores throughout the United States
88
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
HOW TO ADDRESS ELEPHANTS IN THE ROOM
89
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
HOW TO ADDRESS ELEPHANTS IN THE ROOM Whatrsquos inside Blood Shot bull Citrulline Malate 4000mg
ldquoL-citrulline is also used to alleviate erectile dysfunction caused by high blood pressurerdquo
bull Beta Alanine 2000mg (may be using source in violation of patents) bull Rhodiola Rosea 300mg bull Caffeine 200mg bull ldquoHabitual caffeine use is also associated with a reduced risk of Alzheimers
cirrhosis and liver cancerrdquo bull N-phenethyl dimethylamine 100mg bull 13-dimethylamylamine - DMAA 60mg bull 14-dimethylamylamine - DMAA 60mg bull Noopept 60mg
90
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
HOW TO ADDRESS ELEPHANTS IN THE ROOM Blood Shot Precautionary Labeling bull This product contains several stimulants that it might increase the chance of
serious side effects such as rapid heartbeat increase in blood pressure and increase the chance of having a heart attack or stroke
bull DMAA - 13-Dimethylamylamine In clinical research taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure
91
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
TAKEAWAYS
92
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93
TAKEAWAYS
bull 1 Elephants are everywhere bull 2 Excellence is not cheap creating challenges for supply chain bull 3 FDA remains resource-constrained creating an un-level
playing field resulting in serious economic disincentives for companies that invest in their supply chain and compliance
bull 4 The mish-mash of standard-setting testing initiatives being pursued by credible thought-leaders while laudable will unlikely be adopted by a majority of firms and therefore seems unlikely to lead to a long-term rise in consumer belief in quality
93