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Industry Beware—FDA is Watching Tweets and Posts

Article

by Jackie Kuler -

In recent years, social media has been a major vehicle for the advertising and promotion of dietary supplements. The law regarding this area of advertising is evolving and still, in many areas, remains unsettled.

In a recent Warning Letter to Zarbee’s Inc., FDA objected to various cough, cold, allergy and sleep claims being made by the company on its website, as well as on the company’s Twitter and Facebook pages. The products cited in the warning were Zarbee’s Naturals Children’s Cough Syrup-Grape, Zarbee’s Naturals Seasonal Relief and Zarbee’s Naturals Sleep supplements. Some of the claims made by Zarbee’s that the FDA objected to include “clinically supported to work fast and offer congestion relief so you can breathe better in every season;" “Try @Zarbees #naturalremedies for Cold and Cough Season…;" “Proven congestion relief;" and “I feel much safer taking these tablets, compared with prescription or OTC sleeping pills."

It is nothing new and no surprise that FDA is monitoring social media forums for objectionable claims. What makes this warning letter a bit different than other similar letters is that FDA went on to object to several personal testimonials that appear on Zarbee’s Facebook page in which individuals recommend or describe the use of Zarbee’s products for therapeutic purposes which, according to the agency, “ are endorsed or promoted by Zarbees."

In some cases, Zarbee’s “liked" the testimonials (e.g., “I’ve been battling either bronchitis or pneumonia for the last 18 days and have tried everything…your Children’s Cough Syrup and mucus relief got rid of…my hoarsness [sic]…[m]y throat and chest are beginning to feel so much better…"). In other cases, the company commented on testimonials that included therapeutic claims for its products. For example, in response to the post, “…I received your…Zarbee’s Naturals Children’s Sleep Product. I have a daughter…born with cerebral palsy and she suffers from Complex Regional Pain Syndrome…[s]he took the samples you sent and slept through the night…best sleep she has had in years," the company responded, “Mary, Thank you for writing this!!! We love to hear that we have helped people…"

This is not the first time FDA has objected to claims made in consumer testimonials posted on Facebook which a company has subsequently “liked" or commented on. In 2012, FDA objected to AMARC Enterprises Inc. “liking" a therapeutic claim made for its Poly-MVA product (“Poly-MVA has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation").

While FDA’s objection is not novel, now is a good time for industry to be reminded that it is the agency’s position that “liking" or commenting on a testimonial posted on a forum that a company is hosting equates to that company endorsing or promoting the claim and the company being responsible for the content.

What the warning letter does not indicate is whether FDA would consider a company responsible for third-party user-generated content (UGC) appearing on a social media forum hosted by a company if the company does nothing to expressly or implicitly endorse or promote the post.

Two draft guidance documents applicable to statements made about prescription drugs in social media platforms indicate that FDA may not necessarily hold a company responsible for all UGC appearing on a blog or page hosted by such company. The first draft guidance was published in January 2014 and addresses the legal responsibility of a prescription drug company to report promotional materials for its drugs to the agency at the time of initial dissemination. The second was issued last month and provides advice on how a prescription drug company should go about correcting independent third-party misinformation about drugs marketed by such company, if it voluntarily chooses to do so.

 FDA takes a similar position in both guidance documents—“Firms are generally not responsible for third-party UGC about their products when the UGC is truly independent from the firm (e.g., not produced by, or on behalf of or prompted by the firm in any particular) regardless of whether the firm owns or operates the platform on which the communication appears."

Therefore, it is FDA’s position that prescription drug companies are not required to report promotional claims or correct misinformation posted by independent third-parties even if the claims appear on a company owned and operated social media platform.

In both instances, FDA cites the Communications Decency Act of 1996 (CDA) as the basis for its position. The CDA provides that:

“No person or user of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider."

In essence, the CDA exempts “Internet service providers" from liability for defamatory comments posted by third parties. The term “Internet service provider" is broadly defined to include the host of a blog or page who simply allows users to use their forum as a communicative outlet. The CDA permits, but does not require, an Internet service provider to remove defamatory content posted by another.

It is far from clear whether the position taken by FDA in the two guidance documents dealing with prescription drugs would apply to third-party user-generated statements about dietary supplements appearing on company owned or controlled forums. While uncertainty still exists, a prudent course of action would be to periodically monitor company-owned or controlled social media forums for objectionable disease and/or false or misleading claims and consider removing such claims from the platform.

To learn more about laws that regulate the supplement and functional foods market, check out INSIDER’s Regulatory Content Library.

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