FDA issues Lilly three advertising warning letters, including one over an Oprah special

The FDA sent Eli Lilly three warning letters dated September 9, 2025, over promotional communications for its tirzepatide drugs Zepbound and Mounjaro. The most prominent letter targets "An Oprah Special: Shame, Blame, and the Weight Loss Revolution," a 42-minute program the agency says misbranded both drugs by omitting or minimizing serious risks ^[1][3].

The special originally aired on ABC as a primetime Oprah Winfrey program on March 18, 2024, and appeared on Hulu the next day ^[1]. The FDA's letter, addressed to Lilly CEO David A. Ricks, notes that the show featured two paid Lilly consultants, Dr. W. Scott Butsch and Dr. Amanda Velazquez, along with Rhonda Pacheco, Lilly's group vice president of diabetes and obesity ^[1]. Because company representatives made benefit claims on camera, the agency treated the broadcast as a direct-to-consumer promotional video and said it was "false or misleading" under the Federal Food, Drug and Cosmetic Act ^[1].

What the FDA said was missing

Both Zepbound and Mounjaro carry a boxed warning about the risk of thyroid C-cell tumors. The FDA says the program mentioned the risk for people with a history of medullary thyroid carcinoma but left out the contraindication for patients with a personal or family history of Multiple Endocrine Neoplasia syndrome type 2, or MEN 2 ^[1][3].

The agency also said several warnings and precautions were omitted entirely: severe gastrointestinal disease, acute kidney injury, hypersensitivity reactions, hypoglycemia, diabetic retinopathy complications in people with type 2 diabetes, and suicidal behavior and ideation ^[1][3]. The show did include a segment on side effects running from about 33:35 to 37:47, but the FDA said it ended with misleading statements from company representatives ^[1].

One exchange drew particular attention. Asked about "serious health effects down the road," Velazquez said: "There's been a lot of hype around like pancreatitis, gallbladder complications, concerns for thyroid cancer. This has really not been shown in human studies that this is a downstream complication, and that really the risk is less than 1%" ^[3]. The FDA wrote that those statements "misleadingly minimize the serious risks of Zepbound and Mounjaro, including the boxed warning" ^[3].

The letter also faults Lilly for not submitting the material to the agency when it was first disseminated, as required by federal regulation, and points to earlier FDA advisory comments from June 13 and June 21, 2022, that had urged Lilly not to minimize gastrointestinal risks in Mounjaro promotional drafts ^[1].

Novo Nordisk received its own September 9 letter over the same broadcast, covering Wegovy and Ozempic (semaglutide) and Victoza (liraglutide), addressed to CEO Maziar Mike Doustdar ^[4]. Reuters reported the Lilly letters cite three media interviews, including the Oprah special ^[2]. A Lilly spokesperson said the letters referred to interviews conducted by independent media, over which the company had no editorial control, and that Lilly did not consider them advertisements ^[2][5].

Why it matters for patients

Nothing in these letters changes the approved labeling, the availability, or the prescribing of tirzepatide or semaglutide. What they change is the information environment. The FDA's core complaint is that millions of viewers heard a favorable account of these drugs from people with financial ties to the manufacturers, without the full risk picture that appears on the label ^[1][3].

That matters because the specifics the FDA flagged are the kind patients discuss with a clinician: whether a family history of MEN 2 or medullary thyroid cancer rules the drugs out, and warnings about kidney injury, gallbladder disease, pancreatitis, low blood sugar, eye complications in diabetes, and mood changes ^[1]. The FDA is also asking both companies to submit a plan to send corrective communications to the audiences that saw the original material, so some viewers may eventually see follow-up messaging ^[3].

What happens next

The FDA told the companies to respond within 15 working days and said it could pursue legal action, including seizure or injunction, if violations are not corrected ^[2]. Whether Lilly or Novo will formally contest the "advertisement" characterization is not yet known.

The letters were part of a broader push. FDA Commissioner Marty Makary said the agency would send roughly 100 cease-and-desist notices and thousands of letters, after President Trump signed an executive order on disclosure in direct-to-consumer prescription drug advertising on the same day the letters were dated ^[2].