FDA cites Novo Nordisk again for misleading GLP-1 ad

The US Food and Drug Administration has issued another untitled letter to Novo Nordisk for airing a TV ad for one of its glucagon-like peptide-1 (GLP-1) receptor agonist drugs. The agency said the Ozempic (semaglutide) ad misleads customers about who is eligible to take the injections.

Three weeks after sending Novo Nordisk an untitled letter about an ad for its GLP-1 Wegovy (semaglutide) pills, FDA issued a similar letter for Ozempic for overstating the efficacy of the injections. In the previous ad, the agency also argued the company misled consumers into thinking the pill form of the drug is better than other GLP-1 drugs that are currently only available as injectables. (RELATED: FDA cites Novo Nordisk for airing misleading Wegovy ad, Regulatory Focus 10 February 2026)

FDA described the Ozempic ad, which featured three people: one representing Ozempic, another representing other type 2 diabetes GLP-1 drugs, and a third person, Stan, who discussed the differences between the drugs. The agency noted that the ad claimed that Ozempic is the GLP-1 drug with the most approved uses for adults with type 2 diabetes, which it says is misleading because it implies that all patients with type 2 diabetes are candidates for all FDA-approved indications for Ozempic and fails to note that they must show concurrent disease states. It added that patients with type 2 diabetes must also show they have established cardiovascular disease or chronic kidney disease for specific indications.

“We acknowledge that the full FDA-approved indications are shown in the SUPERs following the corresponding voiceover claims,” said FDA. “However, the inclusion of this information is not sufficient to correct the overall misleading impression created by the claims in the voiceover at the beginning of the video.”

FDA stated that later in the ad, Stan tells the other GLP-1 character that they don't have as many FDA-approved uses as Ozempic, which the agency said creates a misleading impression that Ozempic is superior to other GLP-1 drugs.

FDA also took issue with the color of the shirts that the characters were wearing. It noted that the vibrant orange shirt worn by the Ozempic character, compared to the dull gray shirt worn by the other GLP-1 character, visually implied superiority.

“According to the CLINICAL STUDIES section of the FDA-approved prescribing information (PI) for Ozempic, the studies supporting the indications pertaining to concurrent established cardiovascular disease and chronic kidney disease were placebo-controlled trials and not designed to measure superiority versus other GLP-1 products,” said FDA. “Thus, the superiority of Ozempic relative to other GLP-1s cannot be determined from the available clinical trial data.

“We are unaware of data supporting the implication that Ozempic is superior to other GLP-1s for type 2 diabetes in these concurrent disease states,” the agency added.

Furthermore, FDA cited Novo Nordisk for not alerting viewers that the ad presents important risk information after the interaction between the two drug actors. On the contrary, the agency said it seems to signal the end of the ad by playing a musical presentation and showing the Ozempic logo.

"The overall effect of disclosing risk information in this manner undermines the communication of risk information and thereby misleadingly minimizes the risks associated with the use of Ozempic," said FDA. "We acknowledge that there is a statement at the top of the video that instructs viewers ‘To see Prescribing Information and Medication Guide, click video, link in this ad, or visit Ozempic-pi.com[.]’

“However, this is not sufficient to mitigate the misleading impression,” the agency added.

Untitled letter

FDA cites Novo Nordisk again for misleading GLP-1 ad

Related topics

Recommended content

Welcome to the new RAPS Digital Experience