FDA Warnings Sent to Lilly, Novo, Hims About Misleading Drug Communications

Ozempic, Mounjaro and Wegovy injectable pens on white background | Image Credit: © K KStock - stock.adobe.com

On Sept. 9, 2025, FDA sent a warning letter sent to Eli Lilly and Company (Lilly) that has now been made public, regarding a direct-to-consumer program that originally aired in the United States on the ABC television network on March 18, 2024, and has been available ever since on ABC’s website and the streaming service Hulu (1,2). FDA said it “determined that the video is false or misleading” in its evaluation of two tirzepatide injections, marketed by Lilly as Mounjaro and Zepbound (1).

Who was interviewed for the program? What was Lilly’s contribution?

The TV special, entitled “Shame, Blame, and the Weight Loss Revolution,” was hosted by Oprah Winfrey and, according to FDA’s warning letter, featured W. Scott Butsch, MD, director of Obesity Medicine at the Cleveland Clinic, and Amanda Velazquez, MD, director of Obesity Medicine at Cedars-Sinai Medical Center in Los Angeles, as paid consultants who “receive research funding from companies making GLP-1 [glucagon-like peptide-1] drugs” (1,2).

The Winfrey program also interviewed Rhonda Pacheco, PharmD, who at the time was a group vice-president for Lilly (1). On Sept. 11, 2025, Pacheco was announced as the new president of Takeda Pharmaceuticals’ United States Business Unit (3).

What is FDA alleging has been misrepresented?

FDA determined that the program “creates a misleading impression regarding the safety of Zepbound and Mounjaro” and “omits important risk information and otherwise minimizes the risks of these drug products” (1).

The agency cited failure to adequately disclose a boxed warning for thyroid C-cell tumors, as well as minimization of adverse events such as pancreatitis and hypoglycemia. It also noted that Lilly had not submitted the promotional material for review at the time of dissemination, as required (1).

Where were other FDA letters directed?

As Reuters reported, the FDA warning letter to Lilly was just one among dozens issued on Sept. 9, including another concerning the same ABC program that was sent to Novo Nordisk (4,5). Negelle Morris, Novo Nordisk’s senior vice-president of Cardiometabolic Sales, was also featured in the video, which discussed the company’s semaglutide injections, Ozempic and Wegovy, and the liraglutide injection Victoza (4).

The telehealth firm Hims & Hers Health also received a warning about its compounded semaglutide products, the active ingredient in Ozempic and Wegovy, after FDA found false or misleading claims about those products in a review of the Hims website in August 2025 (5).

The Reuters report cited comments made by FDA Commissioner Marty Makary, MD, during the week that the letters were issued, suggesting that companies needed to present a balanced view of the drugs they promote, while complying with advertising rules—including listing all side effects (5). Makary said FDA intended to distribute approximately 100 cease-and-desist notices, among thousands of other letters.

What does this signal for compliance culture?

The recent cluster of warning letters indicates that advertising, media appearances, and digital platforms are under renewed scrutiny. For companies in competitive therapeutic areas such as metabolic disease, governance frameworks must extend to consultants, third-party platforms, and direct-to-consumer websites.

The agency’s coordinated action suggests that enforcement will no longer be episodic but ongoing, shaped by both scientific evidence and public communication practices.

References

1. FDA. Warning Letter—Eli Lilly and Company. FDA.gov, last updated Sept. 16, 2025 (accessed Sept. 16, 2025).
2. ABC. Watch An Oprah Special: Shame, Blame and The Weight Loss Revolution. ABC.com, March 18, 2024 (accessed Sept. 16, 2025).
3. Takeda. Takeda Appoints Rhonda Pacheco President of the US Business Unit. Press Release. Sept. 11, 2025.
4. FDA. Warning Letter—Novo Nordisk Inc. FDA.gov, last updated Sept. 16, 2025 (accessed Sept. 16, 2025).
5. Roy, M.; Choudhury, K. US FDA Sends Drug Advertising Warning Letters to Lilly, Novo, Hims. Reuters.com, Sept. 16, 2025.