On September 9, 2025, the U.S. Food and Drug Administration (FDA) issued warning letters to Novo Nordisk and Eli Lilly. The warning letters concern a direct-to-consumer video about Novo Nordisk’s semaglutide drugs Ozempic, Wegovy, its liraglutide drug Victoza, as well as Eli Lilly’s tirzepatide drugs Zepbound and Mounjaro. After an investigation, the FDA has found that the video contains false or misleading claims about the safety of the diabetes and weight loss drugs.
Key takeaways about the FDA’s Novo Nordisk and Eli Lilly warning letters
- The FDA has warned Novo Nordisk and Eli Lilly that a video ad posted in 2024 was in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
- The warning states false or misleading statements are contained within the ad about the risks patients may face.
- Payments to physicians to influence their opinions are part of the ongoing personal injury lawsuits against Novo Nordisk and Eli Lilly for unlisted semaglutide, liraglutide and tirzepatide side effects.
What are the Novo Nordisk and Eli Lilly FDA warning letters?
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA has the authority to regulate advertisements of food and drugs under its purview. The agency may issue warning letters to notify companies that are found to violate the standards set by the FD&C Act.
On September 9, 2025, the FDA issued warning letters to the manufacturers of Ozempic, Wegovy, Victoza, Mounjaro and Zepbound regarding a 2024 promotional video hosted by Oprah Winfrey. The video contains statements by an Eli Lilly Vice President, as well as two doctors. These two doctors are paid consultants for Eli Lilly.
The warning describes how the promotional video made misleading statements regarding the potential risks patients face if prescribed semaglutide, liraglutide or tirzepatide drugs. In particular, the letter alleges that the 42-minute-long promotional video omitted key warnings for consumers.
“The video includes numerous representations about the benefits of Zepbound and Mounjaro made by representatives of Eli Lilly, but omits important risk information and otherwise minimizes the risks of these drug products…However, this segment begins with a description from a non-Eli Lilly affiliated health care provider about how patients should be weighing the risks and benefits of taking any GLP-1 drug and, as explained below, concludes after several misleading omissions and statements are made by representatives of Eli Lilly about the risks of Zepbound and Mounjaro.”
- FDA warning letter to Eli Lilly
What are the video’s false or misleading statements?
The FDA has cited several omitted or misleading statements from the video relating to the risks of both thyroid tumors and severe gastrointestinal conditions associated with tirzepatide drugs.
In particular, the FDA warns that Dr. Amanda Velazquez, one of Eli Lilly’s paid consultants, was misleading in her discussion about the potential risks of thyroid tumors for those who take Mounjaro or Zepbound. Both drugs contain boxed warnings for “patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).” Dr. Velazquez is accused of omitting the risk for patients with a history of MEN 2.
Additionally, the FDA’s warning letter accuses Eli Lilly of omitting several serious risks that are warned about on Mounjaro and Zepbound’s prescribing information. According to the letter, these omitted risks include:
- Acute kidney injury
- Diabetic retinopathy complications for patients with type 2 diabetes mellitus
- Severe gastrointestinal disease
- Hypoglycemia
- Hypersensitivity reactions
- Suicidal behavior and ideation
The FDA warning letter also cites statements by Dr. Velazquez that the potential for serious risks with Mounjaro and Zepbound use are “overhyped.” Further, Dr. Velazquez’s statements are alleged to mislead consumers into believing that risks of conditions such as pancreatitis, gallbladder complications, and thyroid tumors are rare and may be “mild to moderate.”
Tirzepatide lawsuits allege Eli Lilly’s funding of physicians
Prior to the FDA warning letter, patients experiencing serious, unlisted side effects from using tirzepatide have filed lawsuits against Eli Lilly. These lawsuits, which have been filed in state and federal courts, allege that the company has a history of making direct payments to doctors in an effort to influence their opinions on Mounjaro and Zepbound.
“The FDA’s action underscores what our clients know all too well — aggressive marketing without full disclosure puts patients at serious risk. Drugmakers like Novo Nordisk and Eli Lilly must be held accountable for downplaying dangers in ads that are arguably deceptive and misleading. We no longer have to wait for a legal reckoning for drugmakers that aren’t fully transparent — it’s here,” stated Motley Rice attorney Jonathan Orent, co-lead counsel and a member of the Plaintiffs' Executive Committee (PEC) for multidistrict litigation against Novo Nordisk and Eli Lilly, makers of diabetes and weight loss drugs including Ozempic®, Wegovy®, & Mounjaro® and other GLP-1 RA medications.
In the Master Complaint filed in the consolidated federal multidistrict litigation (MDL), attorneys for the plaintiffs allege that Novo Nordisk and Eli Lilly spent millions of dollars attempting to influence physicians’ opinions on their diabetes and weight loss drugs. The Master Complaint alleges that Eli Lilly has funded other physicians, such as Dr. Ania Jastreboff, who has appeared on other Oprah Winfrey programming. These payments are alleged to have been part of a strategy to influence public and physicians’ opinions on the safety and efficacy of tirzepatide.
Lawsuits against Eli Lilly allege that patients developed severe health conditions after taking Mounjaro and Zepbound. These conditions include:
● Deep vein thrombosis (blood clots)
● Severe gastrointestinal issues, such as gastroparesis and gastroenteritis
Learn more about our diabetes drug lawsuits
Motley Rice’s medical drug attorneys are representing individuals in lawsuits against Eli Lilly over their diabetes and weight loss drugs. Our attorneys represent clients alleging serious, unlisted side effects from using Mounjaro and Zepbound. Motley Rice has also filed lawsuits of people harmed by Novo Nordisk’s semaglutide drugs Ozempic and Wegovy.
We have filed cases for individuals harmed by GLP-1 drugs in both state and federal courts.
Learn more about our diabetes drug lawsuits.
Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor’s advice can result in injury or death. Ozempic, Wegovy, Mounjaro, Victoza and Zepbound remain approved by the U.S. Food and Drug Administration.