The US Food and Drug Administration said a television ad for Novo Nordisk’s weight-loss pill was “false or misleading,” according to a letter dated Feb. 5.
Wegovi pens are sorted on the packaging line at Novo Nordisk’s facility in Hillerd, Denmark, on March 8, 2024. (File photo/Reuters)The health regulator said the television spot misleadingly suggests that Wegovi, in its pill form, offers progress or improvement over other weight-loss drugs that belong to a class known as GLP-1s.
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“We confirm that Novo Nordisk has received an ‘untitled letter’ from the FDA regarding a television commercial for the Wegovy pill, which is not a Super Bowl ad, that has been running since launch,” said Novo spokeswoman Ambre James-Brown. The agency said Novo’s direct-to-consumer advertising violated the federal Food, Drug and Cosmetic Act and asked the drugmaker to take immediate action to address any violations, which could include stopping all ads containing misleading claims.
James-Brown added, “We take all regulatory feedback seriously and are in the process of responding to the FDA to address their concerns regarding advertising presentation.”
The FDA also said the claims “live lighter” and “away forward” misleadingly imply additional weight loss compared to other currently approved GLP-1 treatments, when this has not been demonstrated.
“Furthermore, they misleadingly imply benefits beyond physical weight loss, such as emotional relief, reduction of mental burden, hope, or direction for patients’ lives, positioning the drug as a solution to a larger life challenge rather than a treatment for a specific condition, when that has not been demonstrated either,” the agency said in the letter.
The FDA has also flagged certain representations in advertising where the on-screen text does not match the audio.
