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KIM KARDASHIAN AND THE FDA: Social Media Marketing Is a Complex Area for Product Marketers and FDA

When Kim Kardashian touted the benefits of the morning sickness drug Diclegis on social media last month, her glowing endorsement instantly reached her 42.6 million Instagram followers and 34.3 million Twitter followers in a very personal way. Holding a bottle of Diclegis, her photo and accompanying endorsement spoke directly to her followers about how the drug had tremendously helped in her struggle with bad morning sickness — catching the attention, and garnering the “likes”, of hundreds of thousands of women … with thousands of women believed to have called their doctor to ask about the medication after reading her glowing post about the drug. Kim is no stranger to controversy regarding the message her actions send to her followers. Ever since her sex tape was leaked to websites like https://www.tubev.sex/ back in 2007, many have questioned the example that she has set to young girls all over the globe.

Her glowing posts also caught the attention of the FDA – and last week Duchesnay Inc., the drug company that makes Diclegis, was issued a warning letter from the FDA. The FDA warning letter stated that Kardashian’s Instagram post was in violation of the Federal Food, Drug, and Cosmetic Act due to misleading claims of efficacy without including any mention of its risks, and ordered the company to “immediately cease misbranding” the product. Duchesnay immediately responded to the FDA warning and complied with FDA regulations, instructing Kardashian to take down the post.

These days, it’s a changing landscape for the marketing of pharmaceutical products – as well as the marketing of dietary supplements. This recent case of Kim Kardashian and the FDA is the latest example of the power, and problem, of social media marketing for today’s health and fitness companies. Although Kardashian did disclose in her post that she was “partnering” with Duchesnay and included links to their websites for drug and safety information, by not including the risks and contraindications surrounding the drug and only praising the drug, she failed to comply with FDA regulations surrounding prescription drug marketing. Unfortunately, when it comes to social media postings, there’s no room for the “fine print” that we’ve all come to know and expect when it comes to the advertising and promotion of products in the health and fitness community – including a full list of side effects and other important consumer information. And companies using celebrities to “casually endorse” a product to their hundreds of thousands of followers through a quick Instagram, Twitter or Facebook post are going to continue to be even more scrutinized by the FDA to ensure that social media posts are complying with all FDA/FTC regulations.

Direct-to-consumer advertising for prescription drugs and other health/fitness products using celebrities to endorse a product is nothing new. What is new, however, is the way that celebrities are now able – and not able — to endorse a product – and the previously uncharted forum of social media for companies in the health care arena. In a time when a single Facebook, Instagram or Twitter post can reach millions of people with a simple click of a mouse, companies today need to be aware of all current FDA/FTC regulations when it comes to drug promotion and social media. When used correctly and complying with all FDA guidelines, social media can be a powerful tool for today’s drug manufacturers and dietary supplement companies. However, as seen by the FDA warning letter received by Duchesnay Inc. surrounding Kardashian’s posts, the FDA is going to continue to aggressively seek out companies that aren’t complying with current regulations surrounding health care social media marketing – and no company wants to find themselves the recipient of an FDA warning letter for social media marketing and misbranding.

Now, more than ever, it’s important for companies in the pharmaceutical, dietary supplements and functional foods arenas to ensure that not only are they complying with all FDA/FTC regulations when it comes to traditional marketing and advertising vehicles, but following all FDA guidelines in social media marketing. Our FDA attorneys are experienced in this area of the law, and can help ensure that dietary supplement companies today are following all regulatory guidelines in this changing area – call us at 516-294-0300 with questions and to see how we can help ensure your company continues to follow all FDA regulations in the changing times ahead.

To read the FDA Warning Letter regarding Kim Kardashian’s social media posts, click here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM457961.pdf