FDA tells Novo Nordisk to stop Ozempic ad, cites misleading claims

The U.S. Food and Drug Administration told Novo Nordisk to stop running a television advertisement for its diabetes drug Ozempic, saying the commercial contains claims that are "false and misleading" about what the medicine can do. The agency's latest warning letter, dated Feb. 26 and disclosed March 3, is the second U.S. advertising notice to the Danish drugmaker in less than a month; an earlier letter on Feb. 5 targeted a television spot for the weight-loss drug Wegovy.

The commercial at issue, titled "There's Only One Ozempic," features actors Justin Long and John Hodgman and has been likened in format to Apple's "Get A Mac" campaign. The FDA said the spot suggests Ozempic is superior to other GLP-1 medicines without evidence to support a comparison, and that it could mislead viewers by implying that all people with type 2 diabetes qualify for every approved use of Ozempic. The agency noted that some benefits cited in promotion apply only to patients with additional conditions such as established cardiovascular disease or chronic kidney disease.

Novo Nordisk has a limited window to reply. The company has 15 working days to respond to the letter and outline steps to address the agency's concerns, which could include revising or halting the advertisement pending clearance. Novo's spokeswoman Liz Skrbkova said, "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."

The warning immediately reverberated in markets and in a regulatory landscape already tense around GLP-1 drugs. U.S.-listed Novo Nordisk shares slipped nearly 1% in overnight trading after the notice and on the reporting day closed roughly 3% lower, reversing a brief run of gains. Regulators and competitors have sharpened focus on how companies market fast-growing diabetes and weight-loss medicines, raising questions about comparative claims and patient eligibility statements in mass-media campaigns.

The Ozempic ad warning arrives against a backdrop of other regulatory scrutiny for Novo Nordisk. In April 2024 the Federal Trade Commission wrote to company executives about suspected improper patent listings for Ozempic, Saxenda and Victoza. Separately, the Food and Drug Administration has conducted multiple enforcement actions tied to counterfeit Ozempic pens in the U.S. supply chain, seizing suspect lots in 2025 and advising patients and pharmacies to verify lot and serial numbers before use.

For patients and clinicians, the FDA's move underscores two practical risks: the potential for misleading advertising to fuel unrealistic expectations about drug benefits, and continuing supply-chain vulnerabilities that can expose users to counterfeit products. The agency's interventions could force prompt edits to national advertising campaigns and sharpen industry compliance with promotional rules, particularly for GLP-1 class drugs that have become a focal point of public attention.

Regulators will watch Novo Nordisk's formal response over the coming weeks. If the company cannot demonstrate that its claims are supported by evidence and not misleading, the FDA could press for corrective communications or broader restrictions on how the drug is marketed to consumers and health-care providers.