July/August 2018www.niemagazine.com

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Compliance, quality and priceare in the balance for the natu-ral products industry’s uniquemission-driven business model

of promoting health and wellness fromseed to shelf. But achieving the goalsthat come with that demands ongoingdiligence. Here, industry experts offertheir take on what constitutes quality inthe natural products world—how toattain and maintain it, and what obsta-cles may lie ahead.

NIE: What are the biggest challenges tocompliance, transparency and qualityfor finished product manufacturers andsuppliers—claims, GMP (good manufac-turing practice) standards, sourcing, orsomething else and why?

Davis: Commitment to quality isalways the foundation of good business.Challenges can be seen more positivelyas opportunities; the one constant withregards to both regulations and cus-tomer expectations is change. The“challenge” for the industry is to findthe best way to anticipate thesechanges, while ensuring that the cost of

46 Nutrition Industry Executive www.niemagazine.com ■ July/August 2018

The Participants Are:

• Elan Mikel Sudberg,CEO, Alkemist Labs,Garden Grove, CAwww.alkemist.com

• Justin Bath,President, Biovation Labs,Salt Lake City, UT,www.biovationlabs.com

• Gisele Atkinson,Vice President,Quality & Technical Affairs,Council for ResponsibleNutrition (CRN),Washington, DC,www.crnusa.org

• Daniel Fabricant, PhD,CEO and President,Natural ProductsAssociation (NPA),Washington, DC,www.npanational.org

• Christen Davis,Director of Quality,North and South America,Lonza Consumer Health &Nutrition,Greenwood, SC,www.lonza.com

• Aaron Secrist,Vice President of Qualityand Regulatory Affairs,NOW, Bloomingdale, ILwww.nowfoods.com

• Ankit Rathi,QA Manager,Specialty Enzymes &Probiotics,Chino, CA,www.specialtyenzymes.com

• John Atwater,Senior Director,USP Verification Services,Rockville, MD,www.usp.org

quality is not increased in order to staycompetitive.

Stakeholders’ expectations for compli-ance are simple; they want to ensurethat they get it right [the] first time.Crucial to this is that manufacturersknow their products, how they are usedand identity upfront the requirementsneeded to meet both customer and reg-ulatory expectations. Once the“Regulatory Design Space” has beendeveloped, the focus is on a flexibleapproach to regulations based on sci-ence and quality risk management, withdesign, consistency and continuousimprovement all key factors.

An additional opportunity for suppli-ers is in ensuring that regulations andexpectations are met throughout thesupply chain. Manufacturers of finishedproducts need transparency across thesupply chain, to ensure suppliers aremeeting the standards required. If theoperations and regulatory teams arealigned on expectations, delivering to ahigh and compliant standard in the firstinstance is seamless.

Fabricant: Agency enforcement.People don’t realize that the industrywants more enforcement, and our mem-bers want more enforcement. Fly-by-night companies are not in for the longgame or to build a reputation, andwarning letters to them gives a blackeye to the responsible industry that is init for the long haul. Responsible industryinvests in GMPs [good manufacturingpractices] and compliance departmentsat their companies. Doing the wrongthing hurts their reputation.

Atkinson: Dietary supplement cGMPshave been a mandatory compliancerequirement for 10 years. However, theFDA (U.S. Food and DrugAdministration) continues to report thatthe percentage of non-compliant com-panies is high when compared to otherregulated industries like food. For exam-ple, FDA reports indicate that approxi-mately 60 percent of cGMP inspectionslast year resulted in FDA having to issuea 483.

Responsible companies have a strongtrack record of compliance with cGMPsand often go above and beyond what isrequired. However, there are still a lot ofthe mid-size and smaller companies withless experience that continue to strugglewith what is required by 21 CFR 111,and then unfortunately there are stillsome outliers that ignore the law alto-gether. Now that we are 10 years intothis regulation, it seems that companiesthat are not able to comply have no

place manufacturing dietary supple-ments.

CRN supports FDA enforcementactions against companies that are non-compliant. FDA needs to get these badactors to come into compliance or faceconsequences. To further complicatethings for the industry, there is a wholenew set of complicated regulations,FSMA (Food Safety Modernization Act),so industry has to step it up andbecome compliant with FSMA becausethe expectation is that cGMP is the mini-mal standard.

Sudberg: From my experience servingfinished product manufacturers, Iobserve that making a full and transpar-ent commitment to quality can be thebiggest challenge for some companies.It’s telling the board that you intend tospend X on quality while last year youspent less. It requires taking quality astep further and testing from seed toshelf, which means identity testing ateach inflection point and, most impor-tantly, testing the finished product. Thatis the biggest challenge since the regu-latory guidance on how much testingthe final product should actually receiveis open to interpretation. To me it’s themost important last step, but the indus-try is slow to make that most importantstep universal. Of course you need totest the individual ingredients along theway, but if the label claims don’t matchwhat's in the bottle, you are liable toboth consumers, FDA, class action attor-neys and any state attorney general. Theprice for getting it wrong is just toohigh—far higher than testing properly.

Secrist: A main challenge is the com-plexity of the global supply chain. I see

more and more botanical ingredientsmoving to China, which makes it harderfor many companies to audit and verifythat their suppliers are following goodmanufacturing practices.

The supply chain is continually chang-ing, so just staying out in front of theissues is a full-time job. Natural productsare especially vulnerable becausegeopolitical issues and increasinglyunpredictable weather patterns aroundthe world can suddenly disrupt the sup-ply chain, which unethical players seizeupon as opportunities. Fortunately, thecompany I work for recognizes that qual-ity is synonymous with brand protectionand provides all the resources my staffand I need to keep ahead of theserelentlessly changing challenges.

Atwater: There are many challenges inthe dietary supplement industry facingingredient suppliers and product manu-facturers in their goal to ensure qualitycompliance and transparency. Finishedproduct manufacturers have a widerange of options when purchasing ingre-dients and are often faced with a needto use multiple suppliers to deliver ontheir product needs.

However, in an increasingly globalmarketplace with much variability in thequality of ingredients, finding consistentsources of high-quality ingredients canbe a challenge. For this reason, finishedproduct manufacturers seek to establisha sound supplier qualification process aspart of their GMP quality systems toreduce risk in their ingredient supplychain.

For ingredient suppliers, they are notonly faced with needing to differentiatetheir ingredients from their competi-tors—hopefully by demonstrating highquality—but also needing to meet dif-ferent requirements for supplier qualifi-cation from multiple finished productmanufacturers. This often means theyare faced with multiple audits and com-pliance challenges to maintain a com-petitive edge.

Bath: If you look at compliance as abare minimum of what the FDA requires,it can be like reading tealeaves.Companies find themselves trying tounderstand where the regulatory body isgoing to go, what type of compliancesituations are going to come up overthe next few years and trying to under-stand the dynamics of the different gov-erning and regulatory bodies. Companyleaders need to take a step back, dotheir homework, and consider what thereal issues and concerns are that regula-tors are focusing on from a compliance

July/August 2018 ■ www.niemagazine.com Nutrition Industry Executive 47

Natural products are

especially vulnerable

because geopolitical

issues and increasingly

unpredictable weather

patterns around the world

can suddenly disrupt

the supply chain, which

unethical players seize

upon as opportunities.

— Aaron Secrist

standpoint and how should they adjusttheir programs, policies and proceduresto be prepared and compliant withthem. For example, the FDA has overthe past several years been focused onmaking sure manufacturers understandand embrace cGMP practices, but goingforward, regulators may be interested infocusing more on brand marketers. Assuch, it will be beholden on the contractmanufacturers to educate its customersto help them get ready for increasedscrutiny from the FDA because thebrand marketers are the ultimate ownerof the formulas and products that arebeing produced by contract manufactur-ers.

Most brands want to sell compliantgoods, but not all of them care as muchabout quality, particularly if it impactsprice. This provides challenges for con-tract manufacturers trying to win a bid,because during the quotation process,responsible contract manufacturers willwork hard to be competitive with thebid while trying to balance the need forquality. This balance means that the bidmay not be the lowest price, and it is adifficult conversation to have with poten-tial customers who may have a propensi-ty to choose the lowest bid. A goodcontract manufacturer must be con-cerned with pricing, but it is alsofocused on developing the highest qual-ity standards available resulting in thehighest quality goods on the market.This approach is ultimately good for thecompany and the industry, but there arecosts associated with quality that are notalways considered by the customer.

Transparency at its heart is beingopen and honest with customers, regu-lators and other stakeholders. Duringthe manufacturing process, when chal-lenges arise, it is important to be trans-parent with the customer regarding notonly the problems, but also the choicesand solutions available. It is a balanceand an art, but it is the way trust is builtamong companies and within the indus-try [to have] open honest communica-tion. The adage good news can wait butbad news is immediate is essential todeveloping a transparent and open dia-logue with customers.

Rathi: I would say a combination of all

of them, but particularly sourcing andidentity testing.

As regulatory and compliance stan-dards become more stringent, it’s morecritical than ever to source from a suppli-er/manufacturer with a robust GMP pro-gram, one with strict process and docu-mentation controls. Certain productspose bigger challenges than others. Forexample, plants or roots handled prima-rily by farms can have water or soil con-ditions that affect what is in them.

At Specialty Enzymes & Probiotics, wemake custom formulas with uniqueingredients. If a company requests aproduct with something like gingerols,derived from ginger root, or bromelain,an enzyme derived from pineapple, wepay even greater attention to where weare sourcing them from and how theyare tested. If such ingredients are usedin your finished product, it’s important towork with a manufacturer with strongprocess and testing controls.

Identification testing, an area of focusfor regulatory agencies, is another stepthat can create a challenge. When multi-ple ingredients are combined in a sup-plement, they may overlap or interferewith identity testing. It’s important touse qualified labs and manufacturingfacilities that have strict controls for test-ing. At times, test methods may not bespecific enough to adequately identifysingle ingredients tested by themselves.In such cases, a combination of thor-ough testing, and process and docu-mentation controls, are required forcomplete and accurate verification.

NIE: What efforts and initiatives do youthink will improve the confidence ofmanufacturers, retailers and consumersin the quality and purity of these ingre-dients and suppliers?

Atkinson: There are a number of self-regulatory initiatives currently beingdeveloped and implemented thatdemonstrate a mature responsibleindustry and are aiming to improvetransparency and stakeholder confi-dence. The Supplement OWL (OnlineWellness Library) label registry is a per-fect example of how industry is open totaking responsibility and being transpar-ent to assist regulators, retailers andconsumers understand the marketplace.Also, the Supplement OWL’s CDX(Commercial Data Exchange) platform(formerly referred to as Tier 2) isdesigned to assist marketers and retail-ers communicate and exchange addi-tional information and support docu-ments about quality practices for theirproducts. Such documents can includesupporting documentation to otherindustry self-regulatory initiatives such asAHPA’s (American Herbal ProductsAssociation) Guidance on GoodAgricultural Collection Practices andGMPs for Botanical Materials and GRMA(Global Retailer and ManufacturerAlliance).

Fabricant: The Supplement Safety andCompliance Initiative (SSCI) is drivingthat train for consumer confidence,transparency and supply chain quality.GNC and Walmart spearheaded it and itparallels the global food safety initiative(GFSI). GFSI never took supplements inso SSCI was created to fill a gap andneed to hold everyone accountable, cre-ate best class practices everyone wouldadopt. The fact that it is retailer-led isespecially important. SSCI will bench-mark standards in the supplement indus-try to hold them to the highest level, sothat third party auditing bodies will allbe on the same page. Many companieshave auditors in their facilities 30 to 40weeks out of the year. Not all of themare of the same caliber. SSCI willaddress that issue as well. It will seek toharmonize with global standards as well.

Davis: Meeting recognized compli-ance standards and the appropriate cer-tifications needed are crucial to increas-ing transparency and building manufac-turers’ confidence in the rigor of sys-tems. Testing to recognized standardsand ensuring certifications, not onlyimprove quality systems and processes,but it ensures a consistently high-qualityend product for our customers.

48 Nutrition Industry Executive www.niemagazine.com ■ July/August 2018

At Lonza Consumer Health & Nutrition(CH&N), we comply with industry stan-dards and regulations across our ingre-dient and dosage form portfolio. Forinstance, thanks to rigorous testing inline with regional standards, Lonza’sCarnipure L-Carnitine has beenapproved in a number of countries glob-ally, including in the US, where it has aself-affirmed GRAS (generally recog-nized as safe) status. This certificationhas also enabled Carnipure L-Carnitineto be used in infant nutrition formulas inthe U.S.

Sudberg: The only sure way toimprove the confidence of manufactur-ers, retailers and consumers in the quali-ty and purity of these ingredients andsuppliers is transparent lab testing.Proudly tell the world what you havetested, by what methods, what the testswere looking for and who did the test-ing. Proudly share every single lab test.Show the world your quality. For toolong, the expense of quality, spenteither internally or externally, has beenhidden. It’s high time to be transparent,because consumers want to hear aboutit. Amazon.com dedicated more “real-estate” on their website to detailedproduct information when they soldtheir turmeric product than anothercompany in this industry. They clearlybelieve that there is a story to be told,and consumers want to hear it.

Secrist: I think that supply chain trans-parency initiatives help to improve theconfidence of consumers, retailers andmanufacturers alike. Over the past sev-eral years, NOW Foods has been veryinvolved with the Supplement Safetyand Compliance Initiative (SSCI). SSCI isan industry-driven initiative led by retail-ers to provide a harmonized benchmarkto recognize various safety standardsthroughout the entire dietary supple-ment supply chain. SSCI is a bold stepforward in providing quality assurancefrom harvest to retailer shelf. Dietarysupplements must meet or exceed theSSCI benchmark to be accepted inmajor retailers, all with the goal of pro-viding quality products and increasingconsumer confidence. A lot of progresshas been made recently to introduceblockchain technology to create an

unbroken chain or history of everythingthat has happened to the raw material,all the way from the seeds going intothe ground to the powdered materialthat shows up at a manufacturer’s door.This has the potential to be a gamechanger for the industry!

Additionally, other organizations havecontributed greatly to the quality assur-ance professional’s toolbox, such asAHPA with their good agricultural collec-tion practices and good manufacturingpractices (GACP-GMP) for botanicalmaterials. This helps give growers, har-vesters and processors the tools theyneed to be able to supply unadulterat-ed, high-quality ingredients, and the

tools that manufacturers need to beable to evaluate the practices of theirsuppliers. The American BotanicalCouncil (ABC) has also been veryinvolved in making sure that the industryis aware of potential adulterationthreats/issues and making sure thatresponsible companies have the toolsthey need to keep these adulteratedmaterials out of the marketplace.

All of these things help bring supplychain GACP/GMP practices into thelight of day where it can be examinedand scrutinized, and what can be exam-ined and scrutinized, can be improved!

Atwater: Third-party scientific verifica-tion services such as USP’s (U.S.Pharmacopeia) Ingredient VerificationProgram (IVP) and Dietary SupplementVerification Program (DSVP) are a com-prehensive and independent way forboth ingredient suppliers and dietarysupplements manufacturers to establishthe quality of their ingredients and fin-

ished products.For suppliers, it is a great way to pro-

vide quality assurance to manufacturersand stand out from other suppliers. Formanufacturers, it can strengthen theirbrand recognition and build consumerconfidence when choosing a qualityproduct through clear transparency, suchas the USP Verified mark awarded tothose products that meet the programquality requirements.

Bath: The only way to improve confi-dence in manufacturers and brands is todevelop more progressive standards.The industry has to be honest with itsconsumer base regarding what theproducts can and cannot provide. Thatis where regulations can come intoplay—they can shape how labeling ishandled, which can be a very goodthing for companies and consumersalike. The best approach would be forthe industry to come together to devel-op a standards body to manage the keytesting that is required by the FDA (puri-ty, potency, strength and composition)and ensure that the transparency creat-ed by those testing methodologies isalso something that is consistently beingpracticed across the industry. This willempower manufacturers and brands tobe transparent and honest about howthey are testing and how they are com-ing to conclusions. This will also allowfor responsible, fact-based marketing.

Third-party audits help engender con-sumer and industry confidence, but it isimportant to choose an independentauditor that will be rigorous and strin-gent such as the NPA, NSF and othersthat have reputations for excellence.

Rathi: I would highlight a couple ofefforts and initiatives: certifications fromreputable third-party vendors; and peri-odic supplier audits go a long waytoward improving confidence in thequality and purity of ingredients andsuppliers.

As a purchaser, you must establishquality systems in place to track andapprove documentation, and test rawmaterials and finished products. Thebuck stops with your quality program.

That being said, for even greater con-fidence in your suppliers or manufactur-ers, more peace of mind, find ones thatare already being checked out by rep-utable third-party agencies. This meansinstead of presenting you with a state-ment stating they follow GMPs, or arekosher or halal, or their products arenon-GMO (genetically modified organ-ism), they provide you with certificationfrom an outside agency who rigorously

For too long, the

expense of quality,

spent either internally

or externally, has

been hidden. It’s

high time to be

transparent, because

consumers want to

hear about it.

— Elan Mikel Sudberg

50 Nutrition Industry Executive www.niemagazine.com ■ July/August 2018

audits their facility and program annual-ly, at minimum. It takes time to establisha strong quality program, so look forestablished companies who seek out-side certification. For example, we havereceived GMP and non-GMO certifica-tion from NSF International, kosher certi-fication from OK Kosher and halal certifi-cation from Islamic Services of America.

And lastly, audit your vendors at regu-lar intervals. Walking through the facility,and learning about their documentationand process controls first hand, willimprove your confidence in the qualityand purity of the goods you purchase.

NIE: What do you think are the mostsignificant strides in the past severalyears in regulations, philosophies andtechnologies that allow for more reliablequality and compliance?

Atkinson: One of the most significantstrides in the past several years hasbeen the 2006 Dietary Supplement andNonprescription Drug ConsumerProtection Act, which requires reports ofserious adverse events to be submittedto the FDA by manufacturers of dietarysupplements and nonprescription drugs.Improving both the dietary supplementand OTC (over-the-counter) industry’spost-market surveillance is valuable forconsumer safety.

Fabricant: Passage of the AER(Adverse Event Reporting) bill madesupplements the only commodity offood to have mandatory reporting forserious adverse events. I think that wascritical. It enables the agency to takeaction much quicker on ingredientsfound to cause harm to humans. FSMAalso gave mandatory recall authority tothe agency to remove immediate harmsand it held the ingredient supply chainaccountable. The GMP final rule wasalso a driver for change. It separated thewheat from the chaff. FDA’s dietary sup-plement inspection program does 600annually in the U.S. and another 50 ormore internationally. It continues tohighlight companies that are having dif-ficulties with the basics, such as settingand meeting specifications.

Davis: More than ever, consumers aredemanding greater transparency andunderstanding of how products are pro-

duced. A recent study of supplementusers in the U.S. commissioned by LonzaConsumer Health & Nutrition (CH&N),and conducted by the NaturalMarketing Institute (NMI), found that 61percent of consumers surveyed rate“unquestionable safety” as a prioritywhen purchasing supplements, with 40percent of respondents citing knowingthe source of ingredients as important.This purchasing dynamic has put thespotlight firmly on the supply chain.

Suppliers partnering together for anintegrated supply chain from end to endalso allows quality expectations to bealigned, with the added benefit ofpotential savings due to reduced redun-dancy. As an integrated solutionsprovider, Lonza CH&N offers supple-ment manufacturers a unique end-to-end approach—from ingredients sourc-ing and processing, to dosage forminnovation, to manufacturing and brand-ing commercially ready end-products.

Sudberg: I’m extremely happy toreport that the industry’s tolerance forsecret sauce and proprietary test meth-ods is at an all-time low. In fact, themain purveyor of such poor practices asbeing unwilling to share data and or col-laborate with others to resolve conflict-ing test results has left the industry andher successor vows to take a differentapproach. I feel like the testing lab seg-ment of this industry had a dark isola-tionist period that is now warming up tobetter collaboration and transparency,which ultimately serves all parties better.Importunely, skip lot testing has beengiven the thumbs up by some in theindustry recently for a particularly uni-form product and operation, but someof us see that as a slippery slope thatmay give others producing in a less con-trolled environment encouragement totry the same thing. "Gee, I am so gladthat company deployed skip lot test-ing!" said no consumer ever. My hopesare that such poor practices are shortlived, and quality wins over quick profit.The best quality assurance people in theindustry are committed to testing everylot of every ingredient, testing againduring production, and testing yet againat the finished product stage. That’swhere the whole industry should be, andI believe it will get there.

Secrist: I would cite the supply chaininitiatives I talked about above as someof the most significant strides for theindustry in the areas of quality and com-pliance.

I would also say that some of themost significant strides have been tech-

nological advancements in the area ofanalytical instrument sensitivity. This isboth a blessing and a curse! A blessingin that knowledge is power and can helpus to make improvements where we findpotential issues that have been hidingbehind the limitations of the sensitivityof past instrumentation. It can be acurse because marketers are very fondof saying things like, “zero pesticides”or “free from harmful contaminants” or“100 percent pure.” Scientists know thatthese types of statements are based onthe analytical sensitivity at the time,which eventually will continue tobecome more and more sensitive, driv-ing the limit of detection (LOD) lowerand lower. These types of statementsopen companies up to plaintiff’s lawyerslooking for a quick payday.

It is the incredible sensitivity of ourLC-MS/MS and GC-MS/MS that havemade it possible for our sports line tobe certified by LGC for their InformedSport/Informed Choice. This sensitivitygives collegiate, Olympic and profes-sional athletes everywhere the assurancethat they can safely take our sportsproducts without fear of failing a bannedsubstances test, putting their career andfuture in jeopardy.

Other technology advances in thefield of genetics has made wholegenome sequencing affordable. NOWFoods has invested in the latest technol-ogy related to the genetic identificationof bacterial strains used in our probioticproducts. In the past, many of the probi-otics in use in the industry had, at best,been identified to the species level. Thescience has shown that the various ben-eficial properties associated with probi-otic bacteria are strain specific, enablingprobiotic products formulation to pro-vide specific health benefits. ProbioticStrain Verified products are NOW probi-otic supplements in which the probioticstrains have been analyzed and theiridentity verified using the cutting-edgeRiboPrinter microbial characterizationsystem.

Atwater: There has been continuedprogress on quality in the industry. Withinitiatives such as the DietarySupplements Quality Collaborative(DSQC) in place, members are able towork in concert to advance the qualityand safety of products marketed asdietary supplements in the U.S.

In addition, recent updates by theFDA to help global, domestic, and inter-national customers ensure compliancewith the new FSMA regulations shouldhelp to establish more consistency in

52 Nutrition Industry Executive www.niemagazine.com ■ July/August 2018

quality around the world.Furthermore, new technologies con-

tinue to emerge, such as rapid ID tech-niques for botanical products. This is anarea where USP is doing significant workto help support the use of quality stan-dards for botanical ingredients andproducts. In support of these efforts,USP has updated all of its relevant pro-grams to be reflective of these changesand to be of greater value to ingredientsuppliers and finished product manufac-turers.

Bath: Implementation of the CFRs,specifically 21 CFR Part 111, has helpedprovide some structure to the overallmanufacturing and supplement space.That said, philosophical shifts will bemore impactful on the industry, leadingto more trustworthy and compliant com-panies, rather than just adherence to theCFRs alone. Major global brands areentering the space and these companiesand investors who back them do notwant to bank on “junk science—” theywant to invest in something that willstand the test of time and provide realgrowth. This will force the entrepreneursin this space to step up and strive forthe highest, most stringent levels of

quality to not only compete, but toevolve themselves into attractive targetsfor venture capital investments or acqui-sitions.

Rathi: In terms of regulations, theFSMA is a significant step for both foodand dietary supplement industries. It’sthe biggest piece of regulation that’sbeen passed in more than half a century,and for dietary supplements, decades.The FSMA builds on 21 CFR Parts 110 &111, requiring companies to add a foodsafety plan that includes a hazards analy-sis, and a foreign supplier verificationprogram.

FSMA regulations, combined withcloser monitoring of companies in thedietary supplement industry, supportmore reliable quality and compliance.The industry continues to move towardstricter documentation practices,stronger testing programs, andincreased verification of quality controlsin the forms of certifications for GMPand GFSI—providing for greater trans-parency and confidence in the productsbeing manufactured.

In terms of technology, both in pro-duction and testing, there are manyadvancements. Advancements in testing

allow for lower detection limits andfaster turnaround times. Our lab, forexample, in addition to activity, identityand microbiological testing, now has ICPcapability to test every raw material andfinished product for heavy metals. It alsotests for gluten in house.

NIE: What are the most significant chal-lenges brand marketers now face forcompliance when formulating new prod-ucts?

Atkinson: There was a period of timewhen brand marketers did not fullyunderstand their obligations under GMP.A few years ago, a series of FDA warn-ing letters made it clear that althoughyou may be contracting out the manu-facturing process, your name is on theproduct and therefore you are responsi-ble for ensuring your product has beenmanufactured in compliance with cGMPrequirements. FDA warning letters clear-ly indicate FDA’s position: “Althoughyour firm may contract out certaindietary supplement manufacturing oper-ations, it cannot by the same token,contract out its ultimate responsibility toensure that the dietary supplement itplaces into commerce (or causes to be

July/August 2018 ■ www.niemagazine.com Nutrition Industry Executive 53

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placed into commerce) is not adulterat-ed for failure to comply with dietary sup-plement CGMP requirements.” Over theyears many brand marketers have had tofigure out how to be more engaged intheir supply chain and understandingdetails about where ingredients aresourced, how they are identified, anddetails about manufacturing.

Fabricant: Ingredient innovation. Thepatent rulings on “products of nature”are not consistent, and the U.S. Patentand Trademark Office issued guidanceto its examiners that products of natureare not patentable subject matterunder 35 U.S.C> 101. This should be ahuge concern for dietary supplement,food, and drug manufacturers andingredient suppliers.

Davis: Operating on a global scale isa significant challenge for brand mar-keters when formulating new products.With global sourcing expected to growover the next decade, it is imperativethat manufacturers and suppliers under-stand the global regulatory market andlifestyle expectations and adapt to theevolving requirements in each region.

Sudberg: I see the most significantchallenge brand marketers face forcompliance when formulating newproducts is verifying label claims sinceno off the shelf test methods exist forunique formulas, they have to bedeveloped. Finished products are com-plicated beasts and no method existsto make sure what is on the label is inthe bottle until a lab is tasked with suchwork. It may not be scientifically possi-ble for all products and for such, a let-ter from the lab explaining why can dothe trick. For all else, finished producttesting must be developed. We’rehearing reports of FDA asking aboutthis specific step in verifying labelclaims during their inspections morefrequently.

Secrist: I am going to sound like abroken record, but one of the biggestchallenges that brand marketers facewhen formulating new products forcompliance is traceability. There hasbeen a [trend] by many in the industryto move away from brokers and try toestablish direct relationships with thegrowers and processors of the ingredi-

ents. This is a good thing for the con-sumer, and technology is poised toprovide this to the end consumer insome exciting and new ways.

Although this is not a complianceissue, I would also say that sourcingingredients that are sustainable, arenon-GMO and are naturally derivedalso continues to be a challenge.Consumers expect these things and weas a company are committed to deliver-ing them. Non-GMO ingredients canbe very difficult to verify back to thesource (traceability). We have publiclystated our position on our websitewhich is that we do not believe thatGMO ingredients fit the definition ofnatural and we believe that consumershave the right to know the status ofthese ingredients so they can makeinformed decisions related to the prod-ucts they take to support their health.This becomes very difficult for animalderived ingredients such as gelatin orvitamin D where we cannot certify theGM status of the feed used for theseanimals. We have been very transpar-ent about where we are at in our jour-ney to completely remove GMO ingre-dients from our supply. Sometimes wemay take longer to come to marketthan other companies because we willnot compromise our quality standards,including insisting on the non-GMOstatus of ingredients. Sourcing for someingredients can literally take years.

Atwater: Some of the ongoing qualitychallenges for brand marketers arerelated to new products that requirenew and unique ingredients emergingin the dietary supplement category.Responding to new consumer demandsand market trends with products likegummies and probiotics introduce newterritory for many manufacturers andsuppliers, which can require new tech-nologies to ensure quality control with-in the supply chain.

Bath: One of the biggest challengestoday is protecting intellectual proper-ty, including developing a novel formu-lation that is hard to steal or replicate.This includes having the studies to backtheir novel formulation and then beable to make claims based on the typeof scrutiny that would be present inpeer-reviewed journals (scientificallyproven, double-blind, placebos.)

Working to ensure that the productsthey are producing do not get adulter-ated. This adulteration can come fromcontamination or on purpose.Marketers may be tempted to adulter-ate their products with synthetic rather

than natural ingredients that may ormay not be banned by the FDA in nat-ural products.

Another big challenge is that theyensure they don’t make health-basedclaims that are problematic when align-ing with the FDA’s drug statement:“This statement has not been evaluat-ed by the Food and DrugAdministration. This product is notintended to diagnose, treat, cure, orprevent any disease.” The challenge isthat the FDA changes its stance onwhat is constituted or classified as dis-ease. For example, the FDA is con-stantly changing their view on what is adisease and it can get brands in hotwater because what was a safe state-ment can morph overnight to be aclaim to treat a disease.

Rathi: Two of the most significantchallenges brand marketers face interms of compliance is qualifying theirvendors and contract manufacturers,and making sure their labels and mar-keting materials meet claims.

To do both well, partnering withcompanies that have technical expert-ise and strong quality programs canmake all the difference. The demandfor products manufactured and pack-aged in GMP-certified facilities, non-GMO, gluten free, certified organic,etc. is growing.

Brand marketers must qualify theirpartners’ documentation and testing,and possibly visit their facilities. Newproducts need to be verified via testingand controls.

Partners with technical expertise, likeSpecialty Enzymes & Probiotics, canhelp brand marketers not only createan efficacious and marketable product,but also help with labels and testing.Our company frequently walks brandmarketers through their label claims,any testing issues they encounter (evenreputable third-party labs sometimeshave trouble with enzyme activity andprobiotics identity), and a host of othermatters. NIE

Reference:NMI SORD Proprietary Report for Lonza Consumer

Health & Nutrition – US – 2,000 participants on-line,2017.

54 Nutrition Industry Executive www.niemagazine.com ■ July/August 2018

Extra! Extra!Visit www.niemagazine.com

to read the remainder of this

article, which covers adulteration

prevention, and technology

and regulations.

Compliance, quality and price are in the balance for the natural products industry’s unique mission-driven business model of promoting health and wellness from seed to shelf. But achieving the goals that come with that demands ongoing diligence. Here is the continuation of the feature article where industry experts offer their take on what constitutes quality in the natural products world—how to attain and maintain it, and what obstacles may lie ahead.

NIE: There are hundreds of thousands of natural ingredients/sources for dietary supplements—and still a high potential for adulteration or use of the wrong material. How do you believe adulteration prevention has potentially improved—and what needs to be done to make it even more foolproof?

Davis: Adulteration prevention is a key focus area for manufacturers and suppliers alike. While a deep understanding of required testing is vital, end-product manufacturers are increasingly demanding that suppliers’ quality systems go beyond these minimum requirements. It’s also critical to ensure that the test methods used are based on relevant global, regional and industry-specific regulations, and that these processes are validated to ensure consistency and accuracy.

Fabricant: Enforcement has been a deterrent or band aid, but full implementation and adoption of SSCI (The Supplement Safety and Compliance Initiative) by the industry will certainly be a major driving factor for change in the industry over the next decade.

Sudberg: Adulteration prevention has improved as a result of raised awareness by both consumers and B-to-B. A lowered industry tolerance for substandard labs has also helped, because experienced labs know what to look for. We’ve seen some manufacturers or suppliers identify new forms of adulteration and share that information with the industry, which we applaud, huge proponents of collaboration that we are. There are also groups of experts collaborating on high-risk material, and testing experts identifying best methods for specific types of risks. For example, adulteration of ginkgo from China is extremely common, but we devised a method of analysis using two different HPTLC (high-performance thin-layer chromatography) methods to screen out the most common tricks. One of the methods we use is the recommended Pharmacopoeial method, which is inadequate to see the adulteration by itself unless one knows what to look for, and the other is an alternate HPTLC method that clearly demonstrates the difference between adulterated and non-adulterated ginkgo. Now we routinely run both methods for any ginkgo samples we receive for identity testing. So relying on a lab with extensive testing experience is the best line of defense catching adulteration, particularly in botanicals.

An issue that needs far more attention than it gets is testing lab competency. No lab is proficient at testing everything for everything, that’s just a fact. And since the vast majority of manufacturers are not equipped to handle every kind of testing they would need to do for true compliance and assured quality, manufacturers need to know which labs they can trust to give them results that are supportable using fit for purpose testing methods applied with expertise. Vetting a testing lab prior to using them is essential. Some of the questions to ask include: What do we need tested, and what for? Which labs do that well? What kinds of certifications do they have? Have they been assessed by an outside organization like American Association for Laboratory Accreditation (A2LA)? If they have ISO accreditation, does it apply to what you are having tested, or something unrelated? How transparent are they about the methods they used to test your material (which you need to know so the tests can be duplicated if challenges arise)? What is their process for handling it when testing results in failed material (the answer should be collaborative to find answers)?

While some substances are relatively straightforward to test, botanicals are the most complicated category of dietary supplements to test, requiring true experts to be sure of the results and work through any complications that go with the territory. I can confirm that even manufacturers with decent in-house labs regularly seek out highly specialized testing for herbs because they come to us.

FDA (U.S. Food and Drug Administration) told me they don’t audit labs unless bad data leads to a health hazard, so relying on them to tell you if your testing lab is inadequate is foolhardy. I’ve actually issued an invitation to them to our facility for a training session in botanical identity testing, and hope they will take me up on it.

Nutrition Industry Executive www.niemagazine.com ■ July/August 2018

A Commitment to Quality … Continued

Secrist: Opportunities for adulteration are certainly not decreasing. The continued, ever-expanding global supply chain requires constant vigilance. There are many tools and strategies available, but they require commitment and have to be consistently utilized. These include on site auditing, commitment to ethical and sustainable sourcing policies and the willingness to invest in quality and maintain the standards that are set.

The knowledge regarding the ways that these ingredients are adulterated and the tools to discover them have never been more prolific than they are today. That being said, it takes a high degree of expertise to wield this knowledge and these tools in an efficient and effective way, along with absolute commitment to quality to avoid the many pitfalls and snares of the supply chain and ensure that high quality ingredients are used to make high quality finished products. Many companies are not willing to do the following three things to ensure this happens:

1. Invest in the expertise of someone that can build a high functioning quality system. It isn’t cheap to hire someone with the appropriate skill set and experience to build a quality system from scratch or to overhaul one that is not what it should be. There aren’t a lot of people with this skill set in the industry and the ones that have it are in high demand.

2. Invest in the instrumentation and equipment to do what needs to be done. Primarily marketing companies that aren’t willing to lay out the capital needed to equip and staff a proficient quality control laboratory. Developing methods is time consuming and expensive, standards are expensive, but there is no substitute for reliable in house laboratories. They provide a level of control over and insight into products that can’t be attained with any contract laboratory.

3. Commit to adhering to the standards, specifications, values and tenants even when nobody else is aware or watching. This is known as instilling a culture of quality. It is easy to run a quality system when everything is going well, but you can tell a lot about a company by how they handle the problem situations. Sometimes there are mistakes made during the manufacturing process that require rework or in some cases, discarding the product, or recalls. This is what responsible companies do when there is a problem; they do the right thing regardless of the consequences.

Atwater: New analytical technologies are being employed to identify and counter adulteration and minimize the potential use of wrong ingredients. Some examples include the use of qNMR and DNA-based test methods.

By working with industry and academia, USP has been and continues to be actively involved in exploring and developing public quality standards that employ these new analytical techniques. Continued vigilance and greater participation from industry stakeholders working with USP is needed to help identify cases of adulterated ingredients or misidentified ingredients so that new test procedures can be developed and employed to identify and prevent such occurrences.

Bath: The key to ensuring that adulteration doesn’t happen is adherence to testing. Consistent testing will track and prove that raw ingredients and finished goods are not adulterated. If manufacturers are not testing on a regular and consistent basis, there is a high likelihood that some adulteration can come in. A strong and proactive supply chain management process is also key to preventing adulteration, through vendor validation, and working with raw material suppliers who are known to provide consistently high quality materials.

Rathi: Adulteration prevention has improved as monitoring of dietary supplement manufacturers and suppliers becomes more frequent and stringent. Companies recognize the importance of strong GMP (good manufacturing practice) programs, which not only have strong standards and procedures set up, but also consistently implement them.

Process and documentation controls are critical in making sure the correct materials are used. Robust testing programs improve adulteration prevention. Rigorous identity testing is a greater area of focus to make it more foolproof.

Allergan-control is more critical than ever, as consumers are becoming more aware of their allergies. Allergan testing has made great strides, but needs to become even more scientifically and technically capable.

No company can test for everything, so once again, it’s important to find suppliers with strong experience, certifications from reputable agencies, and a strong combination of testing, quality controls, and hazard analysis to maximize adulteration prevention.

Nutrition Industry Executive www.niemagazine.com ■ July/August 2018

Nutrition Industry Executive www.niemagazine.com ■ July/August 2018

NIE: What is on the horizon in the area of compliance and quality control, e.g. regulations and technology?

Atkinson: The recent restructuring underway in FDA’s Office of Regulatory Affairs, Program Alignment, will have inspectors grouped and assigned by product type rather than assigned by geographical location. Therefore industry can expect more knowledgeable inspectors taking a deeper dive during inspections, resulting in a more detailed and exhaustive look into a company’s policies and programs, which could result in findings that may have previously gone unnoticed. For example, the first phase of cGMP inspections that have occurred over the past ten years may verify that you are performing identity testing of incoming raw materials. Now the inspector may go one step further and evaluate whether the identity test that you are doing is ‘scientifically valid’. However, these changes are expected to result in the agency attaining a better understanding of dietary supplements, ultimately improving the relationship between industry and FDA.

Fabricant: Technology front, it is definitely CRISPR-Cas9 and its use to silence genes in crops rather than inserting DNA into them. Quality control, as I mentioned before SSCI.

Davis: As technology makes our lives more convenient and data-rich, it also increases risk around data accuracy and integrity. At Lonza CH&N, we continue to implement training for colleagues on data integrity and design systems, to ensure both compliance and complete peace of mind for our customers. With products designed and manufactured for commercial success, we need to apply these same principles to the quality systems in place, to ensure that products are regulatory compliant and in line with manufacturers’ expectations.

Sudberg: On the horizon is an arena where products have substantiated claims, and not only efficacy but quality. Branded ingredients are increasingly the predominant material in our products and the need to develop methods to prove their inclusion and label claim will be in high demand as the FDA starts pulling the string on that old sweater.

Secrist: I believe that technology will continue to increase our ability to continuously improve the quality of the raw materials and products. Knowledge is power and now more than ever data is becoming more accessible, and data in the hands of an able and experienced quality professional is like gold! It provides the opportunity to, in a very methodical way, improve everything in the supply chain and throughout the manufacturing process.

I believe that if the industry as a whole can get better at continuous improvement we will effectively be able to regulate ourselves, which will remove the need for future government regulations.

Bath: More testing will come into play. For instance, DNA technology will allow for more accuracy in testing. Technology will also provide quicker results in assay and identity testing. (DNA will not always be applicable, such as in the case of extracts). The timeframe and costs will reduce over time as well, making it more viable to conduct advanced tests that would currently be cost prohibitive. Testing will also become more sensitive and expansive. For instance, today we test for lead and other heavy metals. In the future, tests for impurities will include items such as GMOs (genetically modified organisms), pesticides and other containments that are outside of today’s normal tests.

Rathi: FSMA (Food Safety Modernization Act) and GFSI (global food safety initiative) are hot topics in compliance, as companies look to meet regulations, and strengthen their quality programs. Having more oversight or access to your supply chain is becoming more important.

In terms of technology, stronger identity testing in herbs and probiotics, as well as improvements in allergen testing are critical areas in need of technological development. Testing methodologies are being widely studied and I think we’ll see rapid development in these areas.

NIE: Other comments?

Rathi: Strong quality requires constant and consistent vigilance. We sometimes hear from the end users of our products, who say our enzymes and probiotics offer support for everything from minor digestive issues to chronic conditions. Like our counterparts in the industry, our focus is on them, and the safety, efficacy and purity of the products they receive.