Warning Letters for Misguided Online Direct-To-Consumer Ads and the Age Old Question, “OMG. Have you heard about this?”

Image courtesy of www.pharmpro.com

In this post, I’ve provided a quick rundown of another great source of information about the FDA’s current thinking; the FDA warning letters that have been issued in response to some unfortunately misguided online DTC ads.

As a result, the number of warning letters is increasing, and the platforms on which the offending ads are appearing are becoming more diverse.

To date, the majority of FDA warning letters have been issued in response to online DTC ads appearing on Facebook.

• Most recently in August 2015, Duchensnay, Inc. was issued a warning letter as a result of material that Kim Kardashian posted to Instagram, Twitter, and Facebook (see picture on right) in which she asked “OMG. Have you heard about this?” and touted the efficacy of Diclegis, but failed to directly communicate any risk information of its use. Kim’s social media posts were submitted as a complaint to the Bad Ad Program (more on this below).
• Vitalab Co., Inc. was issued a warning letter in October 2014 citing their website and Facebook posts, which included unapproved claims that their Vit-Ra-Tox products could be used to treat cholera, viruses, parasites, and even broken bones.
• Institut Biochimique SA was issued a warning letter in February 2014 for their Facebook page for their hypothyroidism product TIROSINT due to omission of risk information and omission of material facts (risks associated with its use).
• AMARC Enterprises, Inc. was issued a warning letter in October 2012 after FDA investigators discovered that the company, among other things, had “liked” posts on their Facebook page by customers who claimed that AMARC’s veterinary products had cured their cancer (an unapproved claim).