council for responsible nutrition hot topics in social media hot topics in social media july 9, 2014...
TRANSCRIPT
Council for Responsible Nutrition
Rend Al-MondhiryRend Al-Mondhiry
Regulatory CounselRegulatory Counsel
Council for Responsible NutritionCouncil for Responsible Nutrition
Washington, DCWashington, DC
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The Council for Responsible The Council for Responsible Nutrition (CRN) is a not-for-profit Nutrition (CRN) is a not-for-profit trade association representing trade association representing the interests of the dietary the interests of the dietary supplement and nutritional supplement and nutritional products industryproducts industry
CRN represents more than 100 CRN represents more than 100 companies that manufacture companies that manufacture dietary ingredients, dietary dietary ingredients, dietary supplements, and/or functional supplements, and/or functional foods, or supply services to foods, or supply services to those suppliers and those suppliers and manufacturersmanufacturers
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Some of Our Members:Some of Our Members:
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. . . to sustain and enhance a climate for . . . to sustain and enhance a climate for our member companies to responsibly our member companies to responsibly
develop, manufacture and market dietary develop, manufacture and market dietary supplements and nutritional ingredients.supplements and nutritional ingredients.
CRN’s Mission:CRN’s Mission:
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Regulation of Social MediaRegulation of Social Media
FDAFDA FTCFTC Self-RegulationSelf-Regulation
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FDA RegulationFDA RegulationFDA defines “labeling” broadlyFDA defines “labeling” broadly– “…“…all labels and other written, printed, or graphic matters” on or all labels and other written, printed, or graphic matters” on or
accompanying an article - FD&CA § 201(m)accompanying an article - FD&CA § 201(m)
– ““Intended use” also defined broadlyIntended use” also defined broadlyDetermined by the information the manufacturer provides on product Determined by the information the manufacturer provides on product labeling or accompanying materialslabeling or accompanying materials
Website content is considered an extension of labeling; Website content is considered an extension of labeling; includes sponsored social media sitesincludes sponsored social media sites– Who is responsible for Who is responsible for consumer-generated content consumer-generated content - posts, - posts,
pins, tweets, etc.?pins, tweets, etc.?
– Potential regulatory and legal implicationsPotential regulatory and legal implicationsAdverse event reports (AERs), testimonials/claimsAdverse event reports (AERs), testimonials/claims
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FDA RegulationFDA Regulation
In June 2014, FDA released two draft In June 2014, FDA released two draft guidance documents for industry on guidance documents for industry on social media and internet social media and internet communications about prescription communications about prescription drugs and medical devicesdrugs and medical devices
– Best practices regarding character space limitations Best practices regarding character space limitations and correcting third-party misinformationand correcting third-party misinformation
No similar guidance for dietary supplements, but No similar guidance for dietary supplements, but instructiveinstructive
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FTC Regulation FTC Regulation
FTC and FDA share jurisdiction over claims FTC and FDA share jurisdiction over claims made by food and supplement manufacturers made by food and supplement manufacturers – Two agencies work closely togetherTwo agencies work closely together
All forms of media are subject to the FTC Act All forms of media are subject to the FTC Act prohibitions against deceptive acts and prohibitions against deceptive acts and practicespractices– FTC Guidance documents for marketersFTC Guidance documents for marketers
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.com Disclosures: How to Make Effective Disclosures in Digital Advertising (2013)
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Self-RegulationSelf-RegulationNational Advertising Division (NAD), investigative National Advertising Division (NAD), investigative and judicial unit of the advertising self-regulatory and judicial unit of the advertising self-regulatory system administered by the Council of Better system administered by the Council of Better Business Bureaus Business Bureaus – CRN/NAD Advertising CRN/NAD Advertising
Review Initiative targets Review Initiative targets deceptive or misleading deceptive or misleading dietary supplement advertising dietary supplement advertising
NAD will refer an advertiser to the appropriate NAD will refer an advertiser to the appropriate regulatory agency (i.e., FTC) if the advertiser regulatory agency (i.e., FTC) if the advertiser refuses to participate or adhere to NAD’s findings refuses to participate or adhere to NAD’s findings
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Self-RegulationSelf-Regulation
Council for Responsible Nutrition
Rend Al-MondhiryRend Al-Mondhiry
(202) 204-7672(202) 204-7672
Hot Topics in Social Media
Kelley Drye & Warren, LLP
Katie Bond, Marketing and Advertising Practice Group
Megan Olsen, Marketing and Advertising Practice Group
July 9, 2014
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FDA on Social Media
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FDA on User Generated Content
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I love Wellness Multivitamin! Not only does it help me stay healthy, it’s also ALL-NATURAL!!
FDA on User Generated Content
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FDA on User Generated Content
If UGC posted on a company site is truly independent, the company is not liable for it (probably)
A company can be held liable if it endorses, highlights, or actively solicits non-compliant comments
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FDA Guidance Document
If a platform cannot accommodate all necessary disclosures for a claim, the platform should not be used
• S/F Qualifiers (e.g., “occasional sleeplessness”)
• S/F claim (DSHEA) disclosures
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FTC on Social Media
FTC Endorsement and Testimonial Guides
How does the FTC define an endorsement?
16 C.F.R. § 255.0
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FTC Endorsement and Testimonial Guides
Material Connection Disclosures
16 C.F.R. § 255.5
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FTC Endorsement and Testimonial Guides
What can create a material connection?
Compensation
Free and/or discounted products
Trips
Promises to appear in advertisements
Employment
Contests
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FTC Endorsement and Testimonial Guides Material Connection Disclosures
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FTC Endorsement and Testimonial Guides
Generally Expected Results Disclosures
Example: Average weight loss 10 pounds in 3 months
Unsubstantiated Claims
Companies must be able to substantiate all claims made by endorsers
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FTC Disclosure Guidance
Updated March 2013
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FTC Disclosure Guidance
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Ineffective Disclosures (according to FTC guidance)
FTCDisclosure Guidance
Ineffective Disclosures (according to FTC guidance)
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FTC Disclosure Guidance
Most Effective Disclosure (according to FTC guidance)
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Reducing Risk
Written Social Media Policy
Endorser Contracts
Training
Monitoring
Corrective Action
Documentation of Social Media Practices is Key
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Examples
Examples
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Examples
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Training, Monitoring, Documentation
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Material Connections Disclosures Facebook
X Hyperlinks
X “About” Section
“I am an Age Less Spokesperson” (appears in every post about the product)
X Hyperlinks
X Spon
Ad
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GER Disclosures Proposed Claim: “Age Less helped me lower my cholesterol to 180.”
Example Social Media Post
Twitter – “Ad: Age Less helps me maintain my cholesterol at 180. Average cholesterol maintenance: 190 over 6 months for individuals already in the normal range.***”
***Need to consider DSHEA disclosure
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CDA, Unsubstantiated Claims
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Age Less prevented me from getting any colds during my 3-month tour of Finland!!
#nocolds #healthyallwinter #awesome!!!
Contest
Proposed Age Less Rockstar Contest
To enter contest consumers must post pictures of the Age Less product to social media sites with comments regarding how Age Less helps them feel like a rockstar
Winner receives a $1,000 and a meet-and-greet with Ozzy Osbourne
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Questions?
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