The US Food and Drug Administration says a television ad for Novo Nordisk’s obesity pill contains misleading claims

The Food and Drug Administration said Novo NordiskWegovy’s television advertisement for its newly launched obesity pill Wegovy included “false or misleading” claims about the drug’s abilities and benefits for patients.

In a letter to Novo dated February 5, the FDA said the ad mislabels the oral drug, making its distribution a violation of federal law. The agency asked the drug company to take immediate action to address the violations, which may include stopping all ads containing misleading claims.

In a statement on Monday, Novo Nordisk confirmed it had received the letter and clarified that the ad had been running since the pill’s launch, but was not the company’s Super Bowl spot.

“We take all regulatory comments seriously and are in the process of responding to the FDA to address their concerns about the ad presentation,” Liz Skrpkova, head of media and stakeholder relations at Novo, said in the statement.

This adds to the mounting hurdles the Danish pharmaceutical company faces as it seeks to regain market share from its main competitor. Eli Lilly and cheaper synthetic imitators in the booming GLP-1 market.

The company’s Wegovy pills are key to these efforts. It was the first GLP-1 obesity pill to hit the market in January, and Novo said last week that more than 170,000 American patients are already taking the drug.

Bloomberg first reported on the FDA’s letter on Monday.

In the letter, the FDA said Novo’s advertising misleadingly implied that its pills provided superior benefits to other approved GLP-1 weight loss drugs. The agency said phrases used at this point, including “live lighter” and “way forward,” connote greater weight loss than other treatments and additional benefits beyond that, although there is no evidence to support these claims.

The advertising statements “misleadingly suggest benefits beyond physical weight loss such as emotional relief, reduced psychological burden, hope, or guidance for patients’ lives, positioning the drug as a solution to broader life challenges rather than a treatment for a specific condition, when this has not been proven either,” the FDA said in the letter.

The FDA also flagged the ad for failing to properly present risk information in both audio and text, a requirement for television advertising for drugs.

Also on Monday, Novo Nordisk filed a lawsuit against it He whispered and hersasking the court to block the telehealth company from mass marketing combination versions of Wegovy pills and injections.