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

Council for Responsible Nutrition

Rend Al-MondhiryRend Al-Mondhiry

Regulatory CounselRegulatory Counsel

Council for Responsible NutritionCouncil for Responsible Nutrition

Washington, DCWashington, DC

22 Council for Responsible Nutrition

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


Some of Our Members:Some of Our Members:


. . . 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:


Regulation of Social MediaRegulation of Social Media

FDAFDA FTCFTC Self-RegulationSelf-Regulation


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


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


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


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


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


Self-RegulationSelf-Regulation

Council for Responsible Nutrition

Rend Al-MondhiryRend Al-Mondhiry

[email protected]

(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

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!!


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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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Material Connection Disclosures

16 C.F.R. § 255.5

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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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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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Ineffective Disclosures (according to FTC guidance)

FTCDisclosure Guidance

Ineffective Disclosures (according to FTC guidance)

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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)

Twitter

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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Thank You

Katie [email protected]

Megan [email protected]

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

Documents

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