The Food and Drug Administration (FDA) has issued a warning letter to the maker of an anti-morning sickness drug endorsed by Kim Kardashian in Instagram and Twitter posts. The warning letter is available here.
Kardashian posted a picture of herself with a bottle of Diclegis and wrote that:
OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, including my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, I felt a lot better and most importantly, it's been studied and there was no increased risk to the baby.
The FDA sent a warning letter to the drug maker, Duchesnay, Inc., complaining that Kardashian's social media posts failed to mention any risks associated with the medicine. The FDA wrote that: "The social media post is false or misleading in that it presents efficacy claims for Diclegis, but fails to communicate any risk information associated with its use and it omits material facts. Thus, the social media post misbrands Diclegis within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and makes its distribution violative. These violations are concerning from a public health perspective because they suggest that Diclegis is safer than has been demonstrated."
The FDA's letter also said the "the social media post is misleading because it fails to provide material information regarding Diclegis' full approved indication, including important limitations of use. Specifically, it fails to convey that Diclegis has not been studied in women with hyperemesis gravidarum."
The FDA asked Duchesnay to discontinue the use of the social media posts and to provide an action plan "to disseminate truthful, non-misleading, and complete corrective messages about the issues" raised in the warning letter.
We would point out that the social media posts do not indicate whether Kardashian was paid to endorse the product. The FTC requires that endorsers of a product must disclose if they are connected in some way to the manufacturer of that product. In 2013, the FTC released Guidelines that marketers have to apply the same full disclosure standards for Twitter and other social media that govern traditional media.