FDA warning letters cite Eli Lilly for minimizing Zepbound and Mounjaro risks

The Food and Drug Administration sent Eli Lilly warning letters dated September 9, 2025, saying direct-to-consumer videos promoting the tirzepatide drugs Zepbound and Mounjaro were false or misleading about the drugs' risks ^[1][2]. One letter targets a 42-minute primetime special hosted by Oprah Winfrey, "An Oprah Special: Shame, Blame, and the Weight Loss Revolution," which aired on ABC on March 18, 2024 and appeared on Hulu the next day ^[1].

The FDA said the special featured two paid Lilly consultants, Dr. W. Scott Butsch and Dr. Amanda Velazquez, plus Rhonda Pacheco, Lilly's group vice president of diabetes and obesity ^[1]. The agency treated the program as promotional communication for the company's drugs, and said it was never submitted to the FDA at the time it was published as required ^[1].

What the FDA said was wrong

The letter says the video included a segment on side effects running from about 33:35 to 37:47, but that it ended with misleading statements and omissions ^[1]. When Winfrey asked about the possibility of "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].

Both drugs carry a boxed warning about the risk of thyroid C-cell tumors, and both are contraindicated in people with a personal or family history of medullary thyroid carcinoma (MTC) or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) ^[1]. The FDA said the video mentioned medullary thyroid cancer but left out the MEN 2 contraindication entirely ^[1]. It also said the video omitted warnings for 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 agency noted it had already given Lilly advisory comments on June 13 and June 21, 2022, recommending changes to draft Mounjaro promotional materials so they would not minimize gastrointestinal side effects or misrepresent risk information ^[1].

A second warning letter concerns a sponsored online video interview about Zepbound posted July 11, 2025 on the "Living Oklahoma" site at okcfox.com, featuring Lilly's Dr. Clare Lee and Pacheco ^[2]. The FDA said that segment promoted Zepbound and LillyDirect, the company's self-pay pharmacy, using phrases like "safe and effective authentic medicine," while omitting risk information entirely and leaving out the drug's limitations of use ^[2]. Both letters are signed by George Tidmarsh, director of the Center for Drug Evaluation and Research ^[2].

BioSpace reported that Lilly received three letters in total about GLP-1 promotions, and that Novo Nordisk received one letter about the same Oprah special, which also flagged the missing MEN 2 information and the use of words like "overhyped" to describe side effects ^[3]. The letters themselves do not include a company response; Lilly's full reply is not contained in the documents cited here ^[1][2].

Why it matters for patients

Warning letters are about advertising, not new safety findings. Nothing in these letters changes the approved labels for Zepbound or Mounjaro, and the FDA did not report new side effect data ^[1][2]. What the agency is saying is that some of the most widely seen consumer messaging about these drugs left out risks that appear on the label.

That gap is specific and checkable. The Zepbound label lists warnings for severe gastrointestinal reactions, acute kidney injury, acute gallbladder disease, acute pancreatitis, hypersensitivity reactions, hypoglycemia, diabetic retinopathy complications, suicidal behavior and ideation, and pulmonary aspiration during general anesthesia or deep sedation ^[2]. Mounjaro's label lists pancreatitis, hypoglycemia with insulin or insulin secretagogues, hypersensitivity, acute kidney injury, severe gastrointestinal disease, diabetic retinopathy complications and acute gallbladder disease ^[1]. Both are off-limits for people with a personal or family history of MTC or MEN 2 ^[1][2].

The letters also show that people paid by drugmakers can appear in programming that looks like journalism or entertainment. In the Oprah special, the consultants' funding was disclosed on screen, and Winfrey asked them about it at about the 20-minute mark ^[1]. The Oklahoma segment opened with a sponsorship disclaimer ^[2].

What happens next

The FDA asked Lilly to respond in writing within 15 working days of receiving each letter, to list other promotions with similar claims, and to submit a plan for corrective communications aimed at the same audiences using the same media, duration and frequency ^[2]. The agency warned that failure to fix the problems could lead to legal action, including seizure and injunction ^[2]. Whether Lilly has pulled the videos or issued corrections is not yet known from these documents.