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The U.S. Food and Drug Administration (FDA) has issued a warning to Danish pharmaceutical giant Novo Nordisk regarding a consumer advertisement for its widely used diabetes drug, Ozempic. According to the regulator, the ad contains false and misleading claims about the medication’s benefits and approved uses. The action marks the second regulatory warning the company has received in less than a month over its promotional campaigns.
In a letter dated February 26, the FDA stated that the online advertisement misrepresented Ozempic’s approved indications and appeared to suggest that the drug was superior to other GLP-1 medications used to treat type 2 diabetes. The agency said the commercial could mislead patients and healthcare providers by implying that Ozempic is suitable for all people with type 2 diabetes, even though certain approved uses apply only to individuals who also suffer from heart disease or chronic kidney disease.
Regulators also raised concerns about the advertisement’s comedic approach, which included a scene comparing Ozempic with other GLP-1 drugs. The FDA noted that this presentation may give viewers the impression that competing medications offer little or no benefit, potentially influencing patient decisions and undermining fair competition in the diabetes treatment market.
The FDA has instructed Novo Nordisk to submit a written response within 15 working days of receiving the letter. The company must identify any similar promotional materials and outline the steps it will take to discontinue or correct the advertisements. If the issue is not addressed adequately, regulators could require the company to halt the distribution of the Ozempic advertisement entirely.
This latest warning follows another letter sent to Novo Nordisk on February 5 concerning a television advertisement for Wegovy, the company’s weight-loss medication. The FDA said that promotion also contained misleading elements.
Novo Nordisk acknowledged receiving the FDA’s “Untitled Letter.” Company spokesperson Liz Skrbkova said the firm takes regulatory feedback seriously and is currently preparing a response to address the agency’s concerns about the Ozempic advertising campaign.
The warning comes as the FDA intensifies scrutiny of prescription drug marketing. The crackdown follows an order from U.S. President Donald Trump calling for stricter oversight of how pharmaceutical companies promote medications. Earlier this week, the FDA also sent warning letters to 30 telehealth companies over misleading claims related to compounded GLP-1 drugs used for diabetes and weight management.
