Novo Nordisk’s oral weight-loss drug advertisement has been flagged by the FDA for allegedly misleading advertising.

February 12, 2026  Source: drugdu 29

"/According to the U.S. Food and Drug Administration (FDA), Danish pharmaceutical company Novo Nordisk...For oral weight loss drugsA television advertisement was found to contain “false or misleading” claims.

Novo Nordisk is the manufacturer of semaglutide, a drug that is also produced by Eli Lilly.Tirzepatide is a GLP-1 weight loss drug .

In January of this year, the oral version of semaglutide was approved for marketing in the United States, becoming the world's first oral GLP-1 inhibitor for the treatment of obesity. Novo Nordisk stated last week that more than 170,000 patients in the United States are currently using the drug.

However, in a letter to Novo Nordisk on February 5, the FDA stated that Novo Nordisk's advertising for the drug constituted "misbranding," and therefore its dissemination of the information violated federal law.

In its letter, the FDA stated that Novo Nordisk's advertising was misleading, suggesting that its oral medication was superior to other approved GLP-1 weight loss drugs.

The agency stated that the use of phrases such as "live lighter" and "a way forward" in the advertisements suggests that the drug can provide greater weight loss and additional benefits than other treatments, but there is no evidence to support these claims.

The FDA also pointed out that these statements "misleadingly suggest that the drug can provide benefits beyond simple weight loss, such as mood relief, reduced psychological burden, hope, or direction in life, positioning the drug as a solution to a wider range of life problems rather than a treatment for a specific disease, and these effects have not been proven."

In addition, the FDA criticized the advertisement for failing to meet the requirements for television drug advertising, which require that risk information be presented adequately and appropriately in both audio and text.

The FDA has instructed Novo Nordisk to take immediate action to correct the violations, which may include halting all advertising containing misleading claims.

Novo Nordisk issued a statement on Monday confirming that it had received a letter from the FDA, stating, "We take all regulatory feedback very seriously and are currently communicating with the FDA to address its concerns regarding the way advertisements are presented."

Novo Nordisk sues Hims & Hers, seeking a ban on generic drugs and damages.

Also on Monday, Novo Nordisk filed a lawsuit against telemedicine company Hims & Hers, asking the court to ban its mass marketing of generic versions of the oral and injectable semaglutide and seeking damages.

The FDA allows the existence of compound formulations when there is a shortage of original drugs or, in certain circumstances, to meet the personalized medication needs of patients.

However, although semaglutide was removed from the FDA's shortage list early last year, the related combination drug remains on the market. Novo Nordisk estimates that approximately 1.5 million Americans are currently using the combination version of its drug.

Hims & Hers announced last week that it would launch a low-cost generic version of Novo Nordisk's oral semaglutide, but changed its mind over the weekend and decided to withdraw the plan.

Previously, Novo Nordisk had stated that it would take legal action, and FDA Commissioner Marty Makary had also pledged to swiftly crack down on illegal generic drugs.

The U.S. Department of Health and Human Services (HHS) has referred Hims & Hers to the Department of Justice to investigate whether it violated the Federal Food, Drug, and Cosmetic Act.

https://finance.eastmoney.com/a/202602103645823124.html

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