Kim Kardashian admonished by FDA for drug endorsement

This poses the question of whether celebrities should be allowed to endorse such products, if any at all, since the U.S. doesn’t have regulations on endorsement deals, unlike India where the law states that “no person shall be allowed to engage in misleading representation concerning the standard, quality, quantity or grade-composition” and need for, or the usefulness of a food product.

It all started when the reality TV star posted a photo of herself last month on Twitter and Instagram – holding a bottle of Diclegis, a drug produced by Duschenay Inc. She then went on to explain the Diclegis cured her morning sickness and, “most importantly, it’s been studied and there was no increased risk to the baby“.

Kardashian has over 42 million followers on Instagram and 25 million on Facebook.

The drug company says it is working with the FDA to find a resolution.

We all know that Kim Kardashian West won’t miss out on a business opportunity, even if it means using her second pregnancy to do so. The drug label warns that Diclegis should not be combined with alcohol or other medications that cause drowsiness, such as sleeping aids or certain pain relievers. Whether it is the “fair balance” between the benefits and risk information required for prescription drugs, or disclosures material to a consumer’s understanding of the advertisement, space and format constraints do not excuse advertisers from providing necessary information and doing so in a clear and conspicuous manner. The letter notes that the privately held company received a similar warning in 2013 for omitting risk information from a letter to doctors. Therefore, her “violations are concerning from a public health perspective because they suggest the DICLEGIS is safer than has been demonstrated”.

The Federal Drug Administration quickly issued a warning letter to Duchesnay USA, the maker of the drug.

The FDA approved Diclegis in 2013 to treat vomiting and nausea in pregnant women who do not respond to more traditional measures. Kim got that right, but the FDA alleged that the post failed to comply with prescription drug advertising requirements.

A different version of the drug was recalled by its manufacturer in 1983 following a series of lawsuits alleging links to birth defects.