The U.S. FDA has issued separate warning letters to Eli Lilly (NYSE:LLY) and Novo Nordisk (NVO) regarding claims made about their obesity drugs in an Oprah Winfrey video special.
The video, “An Oprah Special: Shame, Blame, and the Weight Loss Revolution,” mentioned Lilly’s Zepbound and Mounjaro, as well as Novo’s Wegovy, Ozempic, and Victoza. It aired in March 2024 on ABC and Hulu, and is available on demand.
It also featured executives from both drug companies. The FDA determined that the video is false or misleading.
“These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the safety of Zepbound and Mounjaro, which are drugs with multiple serious, potentially lifethreatening risks, including a boxed warning for the risk of thyroid C-cell tumors,” Lilly’s letter reads.
“Consumers and patients who seek medical treatment for managing obesity and excessive weight or their type 2 diabetes mellitus should receive truthful and nonmisleading information regarding the serious risks associated with the use of a weight management prescription drug product,” Novo’s letter states.
The letters also fault both companies for not submitting the video’s content to the FDA at the time of its dissemination as required by law.
The letters to Lilly and Novo were part of about 100 issued to companies recently regarding drug marketing. Hims & Hers Health (HIMS) received a warning letter regarding its marketing of compounded semaglutide, the active ingredient in Wegovy and Ozempic.