FDA Letters Calls on GLP-1 RA Drug Makers to Correct Misleading Video

On September 9, 2025, the FDA issued warning letters to the manufacturers of Ozempic, Wegovy, Victoza, Mounjaro and Zepbound. The warning references a 2024 promotional video hosted by Oprah Winfrey. The video contains statements by an Eli Lilly vice president, as well as two doctors. Both doctors are paid consultants for Eli Lilly and Novo Nordisk.

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 letter emphasizes that the concerns and violations it lists are not comprehensive.

The FDA is concerned that a substantial amount of the content in the videos may be misleading for consumers. This includes:

• Omission of warnings and precautions related to GLP-1 weight loss drugs
• Statements by experts that describe risks as “overhyped” and downplay potential side effects

Omissions and misleading statements about possible side effects

The FDA cites several omitted or misleading statements from the video. These were related to the risks of thyroid tumors and severe gastrointestinal conditions associated with semaglutide, liraglutide and tirzepatide drugs.

In particular, the FDA warns that Dr. Amanda Velazquez, a paid consultant of GLP-1 RA drug manufacturers, was misleading in her discussion about the potential risks of thyroid tumors for those who take Mounjaro, Zepbound, Ozempic, Wegovy or Victoza. 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 Mounjaro and Zepbound’s prescribing information warns about. According to the letter, omitted risks include:

• Acute kidney injury
• Diabetic retinopathy complications for patients with type 2 diabetes mellitus
• Hypersensitivity reactions
• Hypoglycemia
• Severe gastrointestinal disease
• Suicidal behavior and ideation

Describing the risks of weight loss drugs as “overhyped”

The FDA warning letter also cites statements by Dr. Velazquez that the potential for serious risks with Wegovy, Ozempic, Victoza, 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.”

In addition to possible false statements and omissions, the FDA’s letter raises other concerns about the video.

Funding of speakers in the video

The FDA letter alleges that Dr. Butsch and Dr. Velazquez “receive research funding from companies making GLP-1 RA drugs.” This behavior continues a pattern mentioned in lawsuits against Novo Nordisk and Eli Lilly. Nearly 2,700 lawsuits have been consolidated into multidistrict litigation (MDL). An MDL is a court procedure that combines multiple individual cases with common defendants and facts into one docket for pretrial purposes.

These lawsuits have been filed in state and federal courts. They allege that the company has a history of paying doctors in an effort to influence their opinions on GLP-1 RA drugs such as Mounjaro, Ozempic, Wegovy, Rybelsus 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 and Mounjaro and other GLP-1 RA medications.

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 lawsuit also claims that Eli Lilly has funded other physicians, such as Dr. Ania Jastreboff, who has appeared on other Oprah Winfrey programming. Plaintiffs’ lawyers allege that paying physicians is part of a strategy to influence public and physicians’ opinions on the safety and efficacy of drugs containing tirzepatide, semaglutide or liraglutide.

Failure to follow FDA policy

The FDA letter also states that GLP-1 RA drug makers didn’t submit the video to be evaluated by the Center for Biologics Evaluation and Research (CBER). Companies making promotional labeling items and DTC ads must submit the following to CBER:

• A completed form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use)
• A copy of the drug’s most current warning label
• A copy of the promotional content
• Two copies of annotated storyboards and videos or animatics of the proposed ad

The letter also cites the video for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 502(a) of this act states that “a drug or device is misbranded if its labeling proves false or misleading in any particular.”

The FDA’s letters don’t list specific corrective actions. It urges “immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above).”

The letters also provide a deadline of 15 working days from the time of receipt for Eli Lilly and Novo Nordisk to respond in writing. The response must include a plan for addressing the violations. It also warns of “legal action without further notice, including, without limitation, seizure and injunction” if the companies don’t address the issues the FDA raised.

An Eli Lilly spokesperson claimed the company “had no editorial control over” the interviews used in the advertisement. Novo Nordisk also distanced itself, issuing a statement that denied they “placed, requested, sponsored or controlled” the video.

Motley Rice’s medical drug attorneys are representing individuals in lawsuits against Eli Lilly and Novo Nordisk 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 on behalf of people harmed by Novo Nordisk’s semaglutide drugs Ozempic and Wegovy.

We have filed cases for individuals harmed by GLP-1 RA 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. Mounjaro, Ozempic, Rybelsus, Victoza, Wegovy and Zepbound remain approved by the U.S. Food and Drug Administration.