The “Like” With A Bite – FDA Warning Letter Puts Supplement Makers On High Alert

Companies have come to recognize social media as an important communication venue for   engaherbalcapsulesging consumers, who are spending more and more time online. In the more informal world of social media, product makers and retailers work hard at being interactive and approachable. It is generally accepted that exchanging dialogue with a company’s fans or audience on social media pages leads to a more positive overall perception of the company and its products.

The primary desired result of social media engagement is to build relationships that encourage brand loyalty. In building such relationships, using the language and communication style of the audience is one of those intangible yet incredibly important factors that contribute to social media success. Businesses looking to use social media keep these motivations top of mind. In practical application, companies will often hire social media managers to monitor their accounts on platforms such as Facebook® and Twitter®. The kinds of engagement that build relationships with an audience include “liking,” commenting on or re-posting (i.e. republishing) fan posts. On more traditional web sites, companies have included testimonials about services or products on blogs and product information pages.

Against this backdrop, the US Food and Drug Administration recently issued a warning letter to a Utah-based herbal supplement maker. The warning stated that the company, Zarbee’s, Inc., made promotional claims through social media interactions and postings which suggested their natural products were intended for use as drugs. The FDA’s definition of the term “drugs” includes any substance which is intended for treatment, cure, mitigation or prevention of disease, the disease in this case being coughs and colds.

According to the warning letter, the company endorsed or promoted personal testimonials from Facebook users on its page. As examples, the letter listed “Likes” and comments made by the company in response to page visitors:

  • “Liked” the comment: “…[product name] …I received the free sample…and…gave it to my daughter…I could not believe how well it worked! She was recently diagnosed with ADHD and put on medication…causing insomnia…”
  •  “Liked” the comment: “Love Zarbee’s this is the only medicine we use for our 2 year old. Colds and congestion clear up in 2 days.”
  • “Liked” the comment: “Received the sample for allergy relief and my husband had a terrible problem with allergies…he was very impressed on how well it worked for him…”
  • Commented, “Thank you for writing this!!! We love to hear that we have helped people…”
  • Commented, “… [W]e switched that item out with our [product name] which works great!!!”

FDA also noted posts the company had made on its own, and stated these posts provided additional evidence that the products were intended for use as drugs:

  • [Product name] extract…helps thin and loosen wet mucus coughs….
  • “Dark honey [an ingredient used in [product name] and [product name]… is clinically proven to calm coughs and sore throats in children…”.

It is not new in the world of regulatory law and science that statements which suggest a product acts like a drug will be reviewed as drug claims, and that such statements could call into question the approval status of the product as a drug. However, FDA’s observation that “liking” a third party’s comment on social media equates to an endorsement or promotion has not so far been a frequent occurrence. This letter highlights the risks for food, drug and cosmetics (and maybe even medical device) makers who use social media.  Most social media managers have used the Like button without giving much thought to government regulations. Under these circumstances, a random Like could cost the company a lot, yet not having a social media presence is also undesirable.

Once the FDA determines that a company has made claims that a product is intended for use as a drug or that it acts like a drug, the company is exposed to a threat of prosecution for selling an unapproved drug. Also, if the labeling for the product does not conform to the Food, Drug and Cosmetic Act and the regulations, it could be deemed misbranded. FDA alleged that the Zarbee’s social media statements risked violations for being unapproved drugs and for misbranding. 

[A warning letter is a notice that requires a response and further action. Unless the threat to public health and safety is immediate and significant, a warning letter is usually the first action that FDA takes, and if sufficient remedial actions are taken other enforcement may be averted.]

What can supplement or natural products makers do to protect themselves from an enforcement action?   I’ll discuss that in Part II of this two-part blog post.

Deanna Baxam is an attorney at Baxam Law Group, LLC. This post is provided for information purposes only. It is not intended as a substitute for consultation with a qualified attorney.
Copyright 2014, Baxam Law Group, LLC. All rights reserved, you are free to re-post with attribution.
Baxam Law Group, LLC
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