The U.S. Food and Drug Administration has warned Novo Nordisk over a consumer ad for its blockbuster diabetes drug, Ozempic, saying the commercial makes false and misleading claims about the drug’s benefits.
It is the second time in less than a month that the FDA has warned the Danish drugmaker about its misleading ads.
The warning comes amid a broader FDA crackdown on misleading drug advertising, following U.S. President Donald Trump’s order for tighter oversight of how companies promote prescription drugs.
In a letter dated February 26, the health regulator said the online ad misrepresented Ozempic’s approved uses and implied that the drug was superior to other GLP‑1 medicines for type 2 diabetes.
The agency said the commercial suggested that all type 2 diabetes patients were eligible for all of Ozempic’s indications, even though some approvals apply only to patients who also have heart disease or chronic kidney disease.
Regulators also said the ad’s comedic elements, including a scene comparing Ozempic to other GLP‑1s, created the impression that competing drugs lacked meaningful benefits.
The FDA has told Novo Nordisk to submit a written response within 15 working days from the date of receipt of the letter, listing any similar advertisements and explaining how it plans to discontinue them, or cease the distribution of Ozempic.
The first warning letter to Novo, issued on February 5, was about a TV spot for Wegovy, Novo’s weight-loss pill.
“Novo Nordisk received an ‘Untitled Letter’ from the FDA concerning an advertising campaign for Ozempic,” confirmed Novo spokesperson Liz Skrbkova.
“We take all regulatory feedback seriously and are in the process of responding to the FDA to address their concerns regarding the advertisement’s presentation.”
Earlier on Tuesday, the FDA also sent 30 warning letters to telehealth firms over misleading claims about compounded GLP‑1 drugs.