FDA warns Novo Nordisk over the Oprah special video
The FDA told Novo Nordisk that the online version of Oprah Winfrey's 2024 weight-loss special is false or misleading promotion because it did not fairly present serious risks of Wegovy, Ozempic and Victoza.
The U.S. Food and Drug Administration issued a warning letter to Novo Nordisk Inc. on September 9, 2025, saying that a direct-to-consumer video — the special titled "An Oprah Special: Shame, Blame, and the Weight Loss Revolution" — is false or misleading promotion for three of the company's injectable drugs [1]. The letter was addressed to Maziar Mike Doustdar, the company's president and chief executive officer, at its Plainsboro, New Jersey headquarters, and was issued by FDA's Center for Drug Evaluation and Research [1].
The three drugs named are Wegovy (semaglutide), Ozempic (semaglutide) and Victoza (liraglutide) [1]. FDA concluded the video "misbrands" those products under the Federal Food, Drug and Cosmetic Act, citing 21 U.S.C. 352(a), (n); 321(n); 331(a), along with advertising regulations at 21 CFR 202.1(e)(5) and (e)(7)(viii) [1]. The agency also said the material was not submitted to FDA at the time it was first disseminated, as required by 21 CFR 314.81(b)(3)(i) [1].
What FDA said is in the video
The special originally aired on ABC as a primetime Oprah special on March 18, 2024, can still be reached through ABC's website, and appeared on Hulu on March 19, 2024 [1]. FDA's letter notes that the video features Dr. W. Scott Butsch, director of obesity medicine at the Bariatric Institute of Cleveland Clinic, and Dr. Amanda Velazquez, director of obesity medicine at Cedars-Sinai Medical Center [1]. The agency describes both as paid consultants and "representatives" with financial and consultancy connections to Novo Nordisk, citing Centers for Medicare and Medicaid Services Open Payments data covering 2017–2023 for Dr. Butsch and 2019–2023 for Dr. Velazquez; the dollar amounts are redacted in the public version of the letter [1]. At about 20 minutes and 46 seconds, the video displays on-screen text saying the two doctors "consult for and receive research funding from companies making GLP-1 drugs" [1]. The video also features Negelle Morris, senior vice president of cardiometabolic sales at Novo Nordisk Inc. [1].
FDA framed the problem as a public health one, writing that the communication "creates a misleading impression regarding the safety of Wegovy, Ozempic, and Victoza, which are drugs with multiple serious, potentially life-threatening risks, including a boxed warning for the risk of thyroid C-cell tumors" [1].
The risks FDA listed
The letter restates the labeled safety information for each drug. All three carry a boxed warning about thyroid C-cell tumors and are contraindicated in people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2, and in people who have had a serious hypersensitivity reaction to the drug or its ingredients [1]. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with all three [1].
Wegovy's prescribing information also includes warnings about acute pancreatitis, acute gallbladder disease, hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy complications in patients with type 2 diabetes, heart rate increase, and suicidal behavior and ideation [1]. The most common side effects listed for Wegovy include nausea, diarrhea, vomiting, constipation, abdominal pain, headache and fatigue, among others [1]. For Ozempic and Victoza, the most common reactions listed are largely gastrointestinal — nausea, vomiting, diarrhea, abdominal pain and constipation, with decreased appetite and dyspepsia also listed for Victoza [1]. FDA referenced label versions dated March 2024 for Wegovy, September 2023 for Ozempic and July 2023 for Victoza [1].
The agency noted it had sent Novo Nordisk advisory comments on similar issues before — dated March 24, 2010, March 29, 2010, January 14, 2011, May 22, 2013 and April 22, 2016 — on draft Victoza promotional materials, including advice not to minimize or omit risk information about thyroid tumors, pancreatitis, gastrointestinal side effects and hypoglycemia [1].
Why it matters for patients
Much of what people learn about GLP-1 drugs comes from television, streaming and social video rather than a prescribing label. This letter is FDA saying that one widely watched program, which reached viewers on ABC and Hulu, did not present the serious risks of these drugs in a way the agency considers truthful and non-misleading [1]. It also highlights that experts appearing in such programs may have financial ties to the manufacturer, and that a company sales executive appeared on camera [1].
The letter does not say the drugs' approved uses or benefits have changed. It is about how the products were promoted, not about new safety findings [1].
What happens next
The warning letter is dated September 9, 2025 [1]. The portion of the letter available here does not include FDA's specific corrective actions, any deadline for Novo Nordisk's written response, or any company reply, so those details are not yet known from this source [1].
Sources
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