FDA warned Lilly and Novo Nordisk over Oprah Winfrey weight-loss special

The ABC prime-time special hosted by Oprah Winfrey about prescription weight-loss drugs is now part of a federal advertising case. In warning letters dated Sept. 9, 2025, the FDA told Eli Lilly and Novo Nordisk that "An Oprah Special: Shame, Blame, and the Weight Loss Revolution" was false or misleading — about 18 months after it first aired on March 18, 2024 ^[1][2].

The program aired from 8 to 9 p.m. EDT on ABC and streamed the next day on Hulu ^[3]. The FDA letter to Novo Nordisk says the video originally appeared on ABC as a Primetime Oprah Special on March 18, 2024, and then appeared on Hulu on March 19, 2024 ^[2].

FDA reviewed the program as a direct-to-consumer promotional video covering the semaglutide injections Wegovy and Ozempic and the liraglutide injection Victoza ^[2]. A separate letter to Lilly covered the tirzepatide injections Mounjaro and Zepbound ^[1]. FDA said it "determined that the video is false or misleading" in both cases ^[1][2].

The agency said the program "creates a misleading impression regarding the safety of Zepbound and Mounjaro" and "omits important risk information and otherwise minimizes the risks of these drug products" ^[1]. The Lilly letter cited a failure to adequately disclose a boxed warning for thyroid C-cell tumors, and the minimization of adverse events such as pancreatitis and hypoglycemia ^[1]. The letters also said the promotional material was not submitted to FDA at the time it was first disseminated, as required ^[1][2].

FDA described Dr. W. Scott Butsch, director of obesity medicine at Cleveland Clinic, and Dr. Amanda Velazquez, director of obesity medicine at Cedars-Sinai Medical Center, as paid consultants who "receive research funding from companies making GLP-1 drugs" ^[1][2]. The Novo Nordisk letter notes that an on-screen disclosure about those ties appeared at roughly 20 minutes and 46 seconds into the video ^[2].

Rhonda Pacheco, PharmD, who at the time was a group vice president for Lilly, was interviewed on the program ^[1]. On Sept. 11, 2025, Takeda Pharmaceuticals announced her as president of its U.S. business unit ^[1]. Negelle Morris, Novo Nordisk's senior vice president of cardiometabolic sales, also appeared ^[1][2].

The two letters were part of a larger cluster issued Sept. 9, 2025. The telehealth company Hims & Hers received a warning about its compounded semaglutide products after FDA reviewed its website in August 2025 ^[1]. FDA Commissioner Marty Makary said during that week that companies needed to present a balanced view of the drugs they promote while following advertising rules, including listing all side effects. Reuters reported that FDA intended to distribute roughly 100 cease-and-desist notices among thousands of other letters ^[1].

The Novo Nordisk letter also points to earlier FDA advisory comments, dated between 2010 and 2016, on draft Victoza promotional communications that the agency said had similarities to the video ^[2].

Winfrey resigned from the WeightWatchers board and donated her shares to the National Museum of African American History and Culture, saying she did not want "the appearance of any conflict of interest" because WeightWatchers had moved into administering weight medications ^[4]. She had said in December 2023 that she used an unspecified weight-loss drug alongside lifestyle changes ^[4].

Why it matters for patients

The special was presented as a national conversation about obesity and weight-loss drugs, reaching a prime-time audience that included people deciding whether to start treatment. FDA's later conclusion was that key safety information was missing or downplayed ^[1][2].

The risk information FDA says was omitted or minimized includes a boxed warning for thyroid C-cell tumors; contraindications for people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2; and warnings about acute pancreatitis, gallbladder disease, hypoglycemia, kidney injury, increased heart rate, and suicidal behavior and ideation ^[2]. The most commonly observed side effects listed for Wegovy include nausea, diarrhea, vomiting, constipation, abdominal pain, headache and fatigue ^[2].

The agency framed the issue as a public health concern, writing that people seeking treatment for obesity or type 2 diabetes "should receive truthful and nonmisleading information regarding the serious risks" of these products ^[2].

The letters also show regulators examining the financial relationships of on-air medical experts with drugmakers, relationships that viewers generally cannot see unless they are disclosed on screen ^[1][2]. FDA warning letters are addressed to companies, not patients. They do not change the approved labels for these drugs, and the agency did not say the drugs are unsafe — its stated concern was incomplete risk disclosure in the promotional video.

What happens next

The letters seek corrective action from Lilly and Novo Nordisk. FDA has not disclosed what the companies will do in response, and the agency has not said whether further enforcement is planned against the program itself. As of the letters in September 2025, the special was still available on ABC's website and on Hulu ^[1]. Whether it has since been edited or removed has not been reported.