Regulatory Focus™ > News Articles > Facebook, Search Engine Terms Again Focus of Warning Letter to Drug Manufacturer

Facebook, Search Engine Terms Again Focus of Warning Letter to Drug Manufacturer

Posted 27 August 2013 | By Alexander Gaffney, RAC

For at least the fifth time this year, the US Food and Drug Administration (FDA) has issued a Warning Letter to a company referencing claims made about a product on the company's Facebook page, once again illustrating that as companies expand their web presence to social media, FDA regulatory officials are keeping a close eye on their activities.

Background: A Focus on Facebook

FDA has issued 17 Warning Letters in its history that reference Facebook, beginning with a March 2011 letter to AloeElite. Since then, FDA has continued to release a steady drumbeat of letters, with most of them targeting unapproved or misbranded drugs and dietary supplement products. Just one medical device product manufactured by The Avalon Effect has received a letter regarding its promotional materials on Facebook, which occurred in November 2012.

But 2013 has also seen a highly unusual letter involving Facebook, one first reported by Regulatory Focus. The letter to AMARC Enterprises alleged not only improper marketing materials posted on Facebook, but also alleged that the company's "like" of an unapproved claim represented an endorsement of the claim and thus rendered the product misbranded under the Federal Food, Drug and Cosmetic Act.

Auto-Preview of No Distinction to FDA

A new Warning Letter to Vibrant Life, a healthcare product manufacturer alleged by FDA to be manufacturing unapproved drugs, doesn't quite meet the novelty standards of the AMARC letter, but does highlight a recurring trend: FDA's focus on social media.

The 7 August 2013 letter references Oral Chelation products manufactured and marketed by the company, including on its Facebook page. On that page, FDA said it found claims posted by the company that its Life Glow Plus product could treat both gout and heart disease.

Interestingly, in both cases the entire claims were not posted on Facebook, but were instead hosted on the company's main site. FDA's letter actually refers to the automatically generated link preview text that accompanies most postings of links unless the user manually de-selects the link preview option.

Metatags Again the Focus of Enforcement

But even outside of social media, FDA's enforcement teams also said the company's use of metatags on its website were improper. Despite the company lacking FDA approval for any specific disease claims, the company had "supplemented" its claims with metatags "to bring consumers to [its] websites through internet searches."

Metatags are machine-readable terms used most often by search engines to guide consumers to websites most likely to pique their interests. For example, FDA's website might include metatags for "drug recalls" or "medical device approvals" to increase the likelihood that consumers find what they are looking for.

But in the case of Vibrant Life, these metatags were used for illegal purposes under the FD&C Act, FDA alleged. Vibrant's metatags included "heart disease," "heart attack," "fight heart disease," "arthritis," "arthritis pain" and "rheumatoid arthritis," among others-all specific disease claims under federal law, and thus protected.

This is at least the third time this year FDA has cited a company for improperly using metatags to steer consumers to a website.

But if there's a common take-away to be had from these FDA letters-both those referencing Facebook and metatags-it's likely that the medium matters less than the message to agency regulators.


FDA Warning Letter to Vibrant

Vibrant Facebook Page

Warning Letters Referencing Facebook


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