FDA calls foul over Brittany Mahomes’ Kaléo Instagram post

Kaléo’s engagement with Brittany Mahomes’ 2 million Instagram followers has landed it in the FDA’s bad books. After seeing a Mahomes’ Instagram post that “entirely [omitted] all risk information,” the agency sent (PDF) an untitled letter asking Kaléo to change the promotion of its EpiPen rival Auvi-Q.

The untitled letter relates to content Mahomes posted to her Instagram account in paid partnership with Auvi-Q. Mahomes, co-owner of a sports team and wife of NFL quarterback Patrick Mahomes, partnered with Kaléo to promote the role Auvi-Q plays in the management of her kid’s food allergies in January. As part of the pact, Mahomes published an Instagram post about Auvi-Q and her child’s allergic reaction.

FDA officials found fault with Mahomes’ post. The agency said the post is false or misleading because it discusses the benefits of Auvi-Q but “fails to include any risk information about the drug.” According to the FDA, the lack of risk information is concerning “because it creates a misleading impression about the safety of Auvi-Q.”

The FDA letter describes claims about the product, such as “Auvi-Q is the only epinephrine autoinjector out there for infants and toddlers,” in both the video and text portions of the post. Mahomes directed readers to the Auvi-Q Instagram page “for important safety information,” but that failed to appease the FDA.

“This does not mitigate the misleading impression created by the omission of risk information,” the FDA said. “By omitting the risks associated with Auvi-Q, the post fails to provide material information about the consequences that may result from the use of Auvi-Q and creates a misleading impression about the drug’s safety.”

The FDA told Kaléo to send a response addressing its concerns within 15 working days of receiving the letter, which the agency sent July 17. The link to the Instagram post now returns a result that says “Sorry, this page isn’t available.”