FDA sends Eli Lilly three warning letters over Zepbound and Mounjaro promotion
The letters say TV interviews about tirzepatide left out labeled risk information; Lilly says it had no editorial control over the programs.
Eli Lilly received three warning letters from the FDA dated September 9, 2025, and at least one of them questions how the company's drugs came across during a 2024 Oprah Winfrey broadcast [3]. The letters address separate promotions for Zepbound and Mounjaro, both tirzepatide products [1][3]. Together they cite three media interviews, the Winfrey special among them [2].
That special, "An Oprah Special: Shame, Blame, and the Weight Loss Revolution," runs 42 minutes, first aired on ABC on March 18, 2024 and appeared on Hulu the following day [1][3]. The FDA treated the program as promotional material for Zepbound and Mounjaro [1]. Two physicians who consult for Lilly, Dr. W. Scott Butsch and Dr. Amanda Velazquez, are featured, as is Rhonda Pacheco, the company's group vice president for diabetes and obesity [1]. The agency also said Lilly failed to submit the material for review when it was first shown, which FDA rules require [1].
What the letters say was missing
The agency's central complaint is about risk information. A boxed warning on both drugs states they should not be used by anyone with a personal or family history of medullary thyroid carcinoma, or with Multiple Endocrine Neoplasia syndrome type 2, known as MEN 2 [1][3]. According to the FDA, the broadcast left the MEN 2 part out [1][3].
The agency said the program also skipped warnings about severe gastrointestinal disease, acute kidney injury, hypersensitivity reactions, low blood sugar, diabetic retinopathy complications in people with type 2 diabetes, and suicidal thoughts and behavior, all of which are described in the drugs' labels [1][3].
BioSpace reported that in one exchange, Winfrey asked about possible "serious health effects down the road," and Dr. Velazquez answered that there had been "a lot of hype" around pancreatitis, gallbladder complications and thyroid cancer, that these had not been shown as downstream complications in human studies, and that "the risk is less than 1%" [3]. The FDA wrote that the remarks minimized serious risks "including the boxed warning" [3].
A Lilly spokesperson said the letters concerned interviews done by independent media outlets, that the company had no editorial control over them, and that Lilly does not consider them advertisements [2].
Other companies and the broader push
Novo Nordisk drew a similar letter about the same broadcast, covering Wegovy and Ozempic, both semaglutide, and Victoza, which contains liraglutide [2][4]. The FDA said those drugs' benefits were highlighted while their risks were played down, and that the material was never submitted for review [2]. BioSpace reported the Novo letter also objected to language describing side effects as "overhyped" and "mild to moderate" [3]. Novo did not respond right away to a request for comment [2].
Telehealth company Hims & Hers Health was cited over claims about its compounded semaglutide products following an FDA review of its website in August [2]. Reuters reported that dozens of letters went out on September 9, the day President Donald Trump signed an executive order on disclosure in direct-to-consumer drug advertising [2]. FDA Commissioner Marty Makary said roughly 100 cease-and-desist notices and thousands of letters were planned [2]. Hims shares fell more than 7% that afternoon, while Lilly's rose 2.6% [2].
Why it matters for patients
The letters spell out, in public, the safety information the FDA expects to accompany promotion of these drugs. That includes the boxed-warning contraindication for people with a personal or family history of medullary thyroid carcinoma or MEN 2 [1][3][4]. The action also signals that the agency can treat a television interview as drug advertising when company representatives talk about the products [1][2].
A warning letter is not a finding that anyone was harmed, and it does not change the approved labels or mean the medicines are unsafe when used as prescribed. The FDA noted earlier advisory comments to Lilly about draft Mounjaro promotions in June 2022 and to Novo about Victoza between 2010 and 2016, saying the same concern about downplaying risks came up then [1][4].
What happens next
Companies were given 15 working days to reply, and the FDA said it could pursue legal steps such as seizure or an injunction if the problems are not fixed [2]. BioSpace reported that Lilly and Novo must also submit a plan for corrective communications to the audiences that saw the material [3].
Whether either company has answered, what those answers say, and when any corrective messages might appear have not been reported [2][3].
Sources
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eli-lilly-and-company-716485-09092025
- https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-sends-drug-advertising-warning-letters-lilly-novo-hims-2025-09-16/
- https://www.biospace.com/policy/fdas-ad-crackdown-targets-novo-lillys-oprah-special-on-glp-1s
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novo-nordisk-inc-716495-09092025
- https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-sends-drug-advertising-warning-letters-lilly-novo-hims-2025-09-16
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