FDA Warning for Kim Kardashian

FDA Warning for Kim Kardashian

A Lesson in paid and un-paid user testimonials

It is a bit of a surprise to write about Kim Kardashian on a FDA regulatory blog. For clients it is often equally surprising to discover the FDA monitors and enforces social media posts among other mediums of marketing. If you are one of Mrs. Kardashian’s 42 million followers on Instagram you’ve likely heard about her recent post to promote the morning sickness drug Diclegis. The Guardian provided a full write-up on the Instagram post today.

The FDA sent a letter to the drug’s maker requesting the Instagram post be removed and warning statements on the risks associated with the drug be given. The FDA found the promotion “false and misleading” in large part because it omitted the risks of using the drug to treat morning sickness. Yes, the FDA is holding the Duchesnay, Inc. the maker of Diclegis responsible for Mrs. Kardshian’s Instagram. There are a couple of reasons for this. First, the concept of “label” and “labeling” is incredibly broad. Previous posts discussed how the concept expands beyond the product packaging to social media, SEO, and customer testimonials. The test developed under case law is whether an item “supplements” or “explains” a FDA regulated product. If it does, then it is a “label” or “labeling” subject to the misbranding provisions of the Food Drug and Cosmetic Act. Kim Kardashian’s post could be viewed as any other customer testimonial, but typically those testimonials that are included in a company’s social media page. Instead it appears Duchesnay paid Mrs. Kardashian to post the endorsement to her legions of followers. This may be the more likely trigger for the FDA response. Drug marketing is closely regulated. In particular the need for prescription drugs to list side effects. It was not enough for the Instagram post to include a link to the safety information, the full side effects were not disclosed.

Whether your using customer testimonials or celebrity endorsements always review the regulations. This applies to medical devices, drugs, supplements, foods, and cosmetics.

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

1 Comment

  1. Janelle on August 13, 2015 at 6:26 pm

    I’m happy to hear that the FDA is paying attention to ads like these. To trust taking a pill during pregnancy just because good ole’ Kimmy says to…why don’t we just start letting her perform open-heart surgery as well. Great article Mr. Sanchez!

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