Rend Al-Mondhiry

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

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• 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

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Some of Our Members
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CRNs Mission
. . . to sustain and enhance a climate for our
member companies to responsibly develop,
manufacture and market dietary supplements and
nutritional ingredients.
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Regulation of Social Media

• FDA
• FTC
• Self-Regulation

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FDA Regulation

• FDA defines labeling broadly
• all labels and other written, printed, or
  graphic matters on or accompanying an article -
  FDCA 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

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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• In June 2014, FDA released two draft guidance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

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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

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.com Disclosures How to Make Effective
Disclosures in Digital Advertising (2013)
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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 NADs
  findings

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Self-Regulation

• Found that pinned content is testimonial in
  nature and therefore required disclosure of
  typical results (Nutrisystem, Case 5479)
• Claims at issue in NADs review
  included   Christine B. lost 46lbs on
  Nutrisystem.     Michael H. lost 125 lbs. on
  Nutrisystem.

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• Rend Al-Mondhiry
• ral-mondhiry_at_crnusa.org
• [phone]

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Hot Topics in Social Media

• Kelley Drye Warren, LLP
• Katie Bond, Marketing and Advertising Practice
  Group
• Megan Olsen, Marketing and Advertising Practice
  Group

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FDA on Social Media
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FDA on User Generated Content
I love Wellness Multivitamin! Not only does it
help me stay healthy, its also ALL-NATURAL!!
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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
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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

• Ineffective Disclosures (according to FTC
  guidance)

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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
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Examples
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Examples
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Training, Monitoring, Documentation
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Material Connections Disclosures

• Facebook
• Hyperlinks
• About Section
• I am an Age Less Spokesperson (appears in
  every post about the product)
• Twitter
• Hyperlinks
• 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
Age Less prevented me from getting any colds
during my 3-month tour of Finland!! nocolds
healthyallwinter awesome!!!
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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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Thank You

• Megan Olsen
• molsen_at_kelleydrye.com
• 202-342-8677

• Katie Bond
• kbond_at_kelleydrye.com
• 202-342-8433