Just days after aligning itself with Novo Nordisk in a legal fight against Hims & Hers over copycat versions of Wegovy, the U.S. Food and Drug Administration has warned the drugmaker that a television advertisement for its newly launched Wegovy pill contains “false or misleading” claims.

In a letter dated February 5, the FDA said the ad misbrands the oral version of Wegovy, making its continued distribution a violation of federal law. The agency requested that Novo take immediate corrective action, which could include halting ads that contain the disputed claims.

The FDA said the commercial misleadingly suggests the pill offers superior benefits compared with other approved GLP-1 weight-loss drugs, despite no clinical evidence to support that implication. Phrases used in the ad (such as “live lighter” and “a way forward”) were flagged for implying greater weight loss and greater life improvements beyond what the drug has been shown to deliver.

According to the FDA, the messaging goes a step further by framing the pill as a solution to emotional or psychological burdens, suggesting benefits like hope, relief, or direction in patients’ lives. The agency said those claims are not supported by data and improperly position the drug as an answer to bigger life challenges rather than a treatment for obesity.

Regulators also faulted the advertisement for failing to adequately present risk information in both audio and visual form, a requirement for television drug marketing.

Novo confirmed it received the letter and said it is responding to the agency’s concerns. In a statement, the company said the ad has been running since the pill’s January launch but is not related to its Super Bowl advertising.

The warning lands as Novo fights on multiple fronts to defend its position in the booming GLP-1 market. The company is facing intensifying competition from Eli Lilly, as well as pressure from lower-cost compounded versions of GLP-1 drugs that have gained traction through telehealth providers.

Last week, Novo said more than 170,000 U.S. patients are already taking the Wegovy pill, which was the first oral GLP-1 treatment approved specifically for obesity. That early uptake makes the product central to the company’s efforts to regain market share.

As I briefly mentioned earlier, on Monday, Novo filed a lawsuit against Hims & Hers, seeking to stop the company from mass-marketing compounded versions of Wegovy pills and injections.

The warning and the lawsuit show just how much is at stake for Novo. Wegovy has become too important to lose, and regulators are making clear that popularity doesn’t come with special rules.

At the time of publishing this article, Stocks.News doesn’t hold positions in companies mentioned in the article.