FDA Issues Warning Letters to Eli Lilly, Novo Nordisk, and Hims Over Misleading Weight-Loss Drug Advertising
核心洞察
The FDA issued warning letters to Eli Lilly, Novo Nordisk, and Hims & Hers Health (搜索) on September 9, 2025, for misleading advertising of weight-loss medications including Mounjaro, Zepbound, Ozempic, and Wegovy.
The enforcement action targeted a March 2024 ABC television program hosted by Oprah Winfrey where company representatives allegedly minimized safety risks and omitted required boxed warnings for thyroid C-cell tumors (搜索).
FDA Commissioner Marty Makary announced plans to send approximately 100 cease-and-desist notices and thousands of additional letters as part of a shift from reactive to proactive pharmaceutical advertising oversight.
The FDA has issued warning letters to major pharmaceutical companies Eli Lilly, Novo Nordisk, and telehealth firm Hims & Hers Health (搜索) for misleading advertising of popular weight-loss medications, marking a significant escalation in regulatory enforcement following President Trump's executive order targeting pharmaceutical marketing practices.
Coordinated Enforcement Action
On September 9, 2025, the FDA released dozens of warning letters as part of a coordinated crackdown on misleading pharmaceutical advertisements. The action specifically targeted companies promoting GLP-1 receptor (搜索) agonists and related weight-loss treatments, including Eli Lilly's Mounjaro and Zepbound, Novo Nordisk's Ozempic and Wegovy, and Hims' compounded semaglutide products.
The enforcement follows President Trump's executive order focusing on disclosing direct-to-consumer prescription drug advertising, which called for the FDA to step up enforcement of laws regarding misleading or false advertisements.
ABC Television Program Under Scrutiny
The FDA's warning letter to Eli Lilly specifically cited a March 18, 2024 ABC television program titled "Shame, Blame, and the Weight Loss Revolution," hosted by Oprah Winfrey. The program, which has remained available on ABC's website and Hulu streaming service, featured Rhonda Pacheco, PharmD, who was then a group vice-president for Lilly.
According to the FDA, 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." The agency determined that company representatives discussed both medications while omitting or understating boxed warnings and other safety information.
The same program also featured Novo Nordisk's senior vice-president of Cardiometabolic Sales, Negelle Morris, who discussed the company's semaglutide injections Ozempic and Wegovy, as well as the liraglutide injection Victoza. The FDA cited similar concerns about minimizing risks while presenting benefits.
Specific Regulatory Violations
The FDA identified several specific violations in its warning letters. For Eli Lilly, the agency cited failure to adequately disclose a boxed warning for thyroid C-cell tumors (搜索), as well as minimization of adverse events such as pancreatitis (搜索) and hypoglycemia (搜索). The company also failed to submit the promotional material for review at the time of dissemination, as required by regulations.
Hims & Hers Health (搜索) received warnings regarding false or misleading claims about its compounded semaglutide products found during an August 2025 review of the company's website. The compounded products contain the same active ingredient found in Ozempic and Wegovy.
Industry Response and Regulatory Context
A Lilly spokesperson told Reuters that the FDA's letter referred to interviews conducted by independent media, over which the company had no editorial control and did not consider them advertisements. This response highlights the evolving regulatory landscape where traditional boundaries between advertising and media appearances are being scrutinized.
FDA Commissioner Marty Makary emphasized that companies need to present a balanced view of drugs and comply with advertising rules, including listing all side effects. Makary announced plans to send approximately 100 cease-and-desist notices along with thousands of additional letters, signaling a major shift in enforcement approach.
Broader Implications for Direct-to-Consumer Advertising
The enforcement action comes amid growing concerns about pharmaceutical direct-to-consumer advertising practices. According to the new administration, pharmaceutical companies have exploited weak FDA enforcement for three decades, often providing consumers with misleading information through promotional content.
The United States is one of only two countries permitting direct-to-consumer pharmaceutical advertising. A 1997 FDA regulatory change relaxed restrictions on advertisements, leading to an 800% increase in pharmaceutical advertising spending within a decade, according to officials who have accused many companies of creating misleading impressions.
A 2021 systematic review found that direct-to-consumer advertising increases overall prescription requests and boosts the chances of prescriptions from clinicians. However, it also increases rates of inappropriate use, leading physicians to prescribe medications requested by patients despite questioning their clinical appropriateness.
Shift in Regulatory Approach
The FDA is transitioning from reactive, complaint-driven oversight to proactive monitoring of all pharmaceutical advertising. Under the Federal Food, Drug, and Cosmetic Act, the FDA is responsible for regulating prescription drug advertisements, ensuring they represent a "fair balance" of risks and benefits while not forming a "misleading impression" on consumers.
The coordinated nature of these 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 now extend to consultants, third-party platforms, and direct-to-consumer websites.