FDA warns Novo Nordisk that Oprah Winfrey weight loss special misbranded Wegovy and Ozempic
The FDA says promotional material tied to an Oprah Winfrey special understated the serious risks of Wegovy, Ozempic and Victoza, which carry boxed warnings.
The FDA sent Novo Nordisk a warning letter dated September 9, 2025, saying a direct-to-consumer video tied to "An Oprah Special: Shame, Blame, and the Weight Loss Revolution" was false or misleading and misbranded three of the company's medicines [1].
The letter goes to Maziar Mike Doustdar, the company's president and chief executive officer, and was issued by the FDA's Center for Drug Evaluation and Research [1]. The drugs named are Wegovy and Ozempic, both semaglutide injections, and Victoza, a liraglutide injection [1].
What the agency flagged
The special first aired on ABC on March 18, 2024, and showed up on Hulu the next day, March 19, 2024 [1]. FDA wrote that the version it reviewed created a misleading impression about the safety of the three products [1].
Two physicians appear in it: Dr. W. Scott Butsch, who directs obesity medicine at the Bariatric Institute of Cleveland Clinic, and Dr. Amanda Velazquez, who directs obesity medicine at Cedars-Sinai Medical Center [1]. FDA describes both as paid consultants with research and consulting ties to Novo Nordisk, and pointed to federal Open Payments records covering 2017 through 2023 for Butsch and 2019 through 2023 for Velazquez; the payment amounts are blacked out in the published letter [1].
Around the 20-minute 46-second mark, on-screen text said the two doctors "consult for and receive research funding from companies making GLP-1 drugs," according to the letter [1]. Negelle Morris, a Novo Nordisk senior vice president of cardiometabolic sales, also appears [1].
Two procedural problems were cited. The material was not sent to FDA when it was first published, as 21 CFR 314.81(b)(3)(i) requires, and FDA said the video misbrands the drugs under the Federal Food, Drug and Cosmetic Act, pointing to 21 U.S.C. 352(a) and (n), 321(n), 331(a), and 21 CFR 202.1(e)(5) and (e)(7)(viii) [1].
FDA said the stakes are public health ones. All three products carry a boxed warning about thyroid C-cell tumors, and each is contraindicated for people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 [1].
Other labeled risks differ by product. Wegovy's prescribing information lists warnings and precautions for acute pancreatitis, gallbladder disease, low blood sugar, acute kidney injury, hypersensitivity reactions, diabetic retinopathy complications in people with type 2 diabetes, higher heart rate, and suicidal behavior and ideation; its most common side effects include nausea, diarrhea, vomiting, constipation, abdominal pain, headache and fatigue, among others [1]. Ozempic is approved to improve blood sugar control in adults with type 2 diabetes and to cut the risk of major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease [1]. Victoza is approved for type 2 diabetes in adults and in children 10 and older, and for cardiovascular risk reduction in adults with type 2 diabetes and established cardiovascular disease [1].
FDA also wrote that it had sent Novo Nordisk advisory comments about draft Victoza promotions on March 24, 2010; March 29, 2010; January 14, 2011; May 22, 2013; and April 22, 2016, raising some of the same kinds of concerns, such as playing down or leaving out risk information [1].
Why it matters for patients
A warning letter is about how a medicine is promoted, not about whether it is approved or whether it works. The FDA's stated concern was that people deciding about treatment were not getting a clear picture of serious, potentially life-threatening risks [1].
The letter is public, so people can read the agency's specific objections instead of judging from the promotional video's framing [1].
How far the video still travels is not fully settled. FDA noted the special was also reachable through ABC's website, at a link the agency says it last checked on September 8, 2025 [1].
What happens next
Novo Nordisk's reply to the letter has not been reported, and the letter as released does not describe any corrective plan, a response deadline, or a follow-up enforcement step [1].
Sources
Semaglutides.org provides information only, not medical advice. Talk to a licensed provider about your own care before making changes. Some telehealth links are affiliate links and are labeled where they appear.