Rend Al-Mondhiry Regulatory Counsel Council for Responsible Nutrition Washington, DC

1. Rend Al-Mondhiry Regulatory Counsel Council for Responsible Nutrition Washington, DC

2. The Council for Responsible Nutrition (CRN) is a not-for-profit trade association representing the interests of the dietary supplement and nutritional products industry • CRN represents more than 100 companies that manufacture dietary ingredients, dietary supplements, and/or functional foods, or supply services to those suppliers and manufacturers

3. Some of Our Members:

4. CRN’s Mission: . . . to sustain and enhance a climate for our member companies to responsibly develop, manufacture and market dietary supplements and nutritional ingredients.

5. Regulation of Social Media • FDA • FTC • Self-Regulation

6. FDA Regulation • FDA defines “labeling” broadly • “…all labels and other written, printed, or graphic matters” on or accompanying an article - FD&CA § 201(m) • “Intended use” also defined broadly • Determined by the information the manufacturer provides on product labeling or accompanying materials • Website content is considered an extension of labeling; includes sponsored social media sites • Who is responsible for consumer-generated content - posts, pins, tweets, etc.? • Potential regulatory and legal implications • Adverse event reports (AERs), testimonials/claims

7. FDA Regulation In June 2014, FDA released two draft guidance documents for industry on social media and internet communications about prescription drugs and medical devices • Best practices regarding character space limitations and correcting third-party misinformation • No similar guidance for dietary supplements, but instructive

9. FTC Regulation • FTC and FDA share jurisdiction over claims made by food and supplement manufacturers • Two agencies work closely together • All forms of media are subject to the FTC Act prohibitions against deceptive acts and practices • FTC Guidance documents for marketers

10. .com Disclosures: How to Make Effective Disclosures in Digital Advertising (2013)

11. Self-Regulation • National Advertising Division (NAD), investigative and judicial unit of the advertising self-regulatory system administered by the Council of Better Business Bureaus • CRN/NAD Advertising Review Initiative targets deceptive or misleading dietary supplement advertising • NAD will refer an advertiser to the appropriate regulatory agency (i.e., FTC) if the advertiser refuses to participate or adhere to NAD’s findings

12. Self-Regulation • Found that “pinned” content is testimonial in nature and therefore required disclosure of typical results (Nutrisystem, Case #5479) Claims at issue in NAD’s review included: •  “Christine B. lost 46lbs on Nutrisystem.” •    “Michael H. lost 125 lbs. on Nutrisystem.”

13. Rend Al-Mondhiry ral-mondhiry@crnusa.org (202) 204-7672

14. Hot Topics in Social Media Kelley Drye & Warren, LLP Katie Bond, Marketing and Advertising Practice Group Megan Olsen, Marketing and Advertising Practice Group

15. FDA on Social Media

17. FDA on User Generated Content I love Wellness Multivitamin! Not only does it help me stay healthy, it’s also ALL-NATURAL!!

18. FDA on User Generated Content

23. 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

24. 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

25. FTC on Social Media

26. FTC Endorsement and Testimonial Guides How does the FTC define an endorsement? 16 C.F.R. § 255.0

27. FTC Endorsement and Testimonial Guides Material Connection Disclosures 16 C.F.R. § 255.5

28. 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

29. FTC Endorsement and Testimonial Guides Material Connection Disclosures

30. 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

31. FTC Disclosure Guidance Updated March 2013

32. FTC Disclosure Guidance Ineffective Disclosures (according to FTC guidance)

33. FTCDisclosure Guidance Ineffective Disclosures (according to FTC guidance)

34. FTC Disclosure Guidance Most Effective Disclosure (according to FTC guidance)

35. Reducing Risk • Written Social Media Policy • Endorser Contracts • Training • Monitoring • Corrective Action Documentation of Social Media Practices is Key

36. Examples

37. Examples

38. Examples

39. Training, Monitoring, Documentation

40. Material Connections Disclosures • Facebook • Hyperlinks • “About” Section • “I am an Age Less Spokesperson” (appears in every post about the product) • Twitter • Hyperlinks • Spon • Ad

41. 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

42. CDA, Unsubstantiated Claims Age Less prevented me from getting any colds during my 3-month tour of Finland!! #nocolds #healthyallwinter #awesome!!!

43. 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 OzzyOsbourne

44. Questions?

45. Thank You Katie Bond kbond@kelleydrye.com 202-342-8433 Megan Olsen molsen@kelleydrye.com 202-342-8677