FDA WARNING_LETTER - Novo Nordisk Inc.

Novo Nordisk Inc., located at 800 Scudders Mill Road, Plainsboro, NJ, received a warning letter from the FDA dated September 9, 2025. The letter addresses a direct-to-consumer video titled “An Oprah Special: Shame, Blame, and the Weight Loss Revolution,” which promotes WEGOVY, OZEMPIC, and VICTOZA, all injectable drugs for subcutaneous use. This video, featuring paid consultants and a Novo Nordisk executive, aired on ABC on March 18, 2024, and subsequently on Hulu.

The FDA identified the video as false or misleading, thus misbranding the drugs under the Federal Food, Drug, and Cosmetic Act. The promotional content failed to present adequate risk information, particularly concerning serious risks like thyroid C-cell tumors, pancreatitis, and hypersensitivity reactions. These omissions are critical given the drugs" potential life-threatening side effects and their use in treating obesity and type 2 diabetes, conditions affecting millions in the U.S.

The FDA noted that the promotional materials were not submitted for review prior to dissemination, violating 21 CFR 314.81(b)(3)(i). The agency has previously communicated similar concerns to Novo Nordisk regarding promotional content for Victoza.

Novo Nordisk is required to cease the distribution of the misleading video and submit a comprehensive plan to ensure future compliance with FDA regulations. The company must also provide corrective communication to address the misleading impressions created by the video. Compliance with these actions is essential to avoid further regulatory actions.