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

September 24, 2015 | Elaina Howard, PhD, RAC, Clinical Research Scientist II | Regulatory Affairs


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In my last blog post detailing direct-to-consumer (DTC) advertising in the age of social media, I briefly summarized the draft guidances for online DTC advertising activities.

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.

It’s Not the Medium, It’s the Content

Because DTC ads posted on online platforms are a more recent phenomenon compared to print or TV ads, thus far there have been far fewer warning letters issued for DTC ads using this medium. However, the FDA is paying increasingly closer attention to these ads posted via the internet and social media.

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.


These FDA warning letters issued for DTC ads posted online share a theme: the content of the ad should follow the DTC guidances regardless of the platform.

So, if your ad wouldn’t fly in a magazine or on TV, you shouldn’t try it online!

Because the guidances for DTC ads are in draft status and do not yet provide a complete picture of the agency’s thinking on this topic, a best practice would be to ensure that your online ads conform to any applicable guidances for print/TV in addition to those specific to the internet and social media.

What NOT to Do

FDA warning letters can be viewed by anyone online. Some examples of warning letters issued for online DTC ads in recent years include:

  • 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).

In short, if your DTC ad is accurate, is non-misleading, and presents balanced risk:benefit information without making unapproved claims, you are off to a great start when posting a DTC ad online!

badad As mentioned above, complaints about DTC advertisements may be submitted to the FDA’s Bad Ad Program. This program is designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising is truthful and not misleading!

As part of the Bad Ad Program, helpful online resources include continuing education courses as well as educational case studies that are updated periodically with new examples.

Not to Fear; We Can Help!

If you would like an experienced set of eyes reviewing your DTC ads, contact us! We’d be happy to join your team and keep YOUR ad from ending up in the Bad Ad Program’s mailbox!

Category: Regulatory Affairs
Keywords: Bad Ad Program, DTC Ads, Facebook, Internet, Prescription Drug Promotion, Social Media, Warning Letters

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