The US Food and Drug Administration on Tuesday released approximately 100 warning letters it had sent to drug companies on September 9, alleging that the companies made false or misleading claims on their websites or in electronic advertisements. Major companies, including Hims & Hers Health and Eli Lilly, were among those targeted, with many letters focusing on weight-loss medications.

The letters cite violations of various provisions of the Food, Drug, and Cosmetic Act (FDCA), which prohibits the distribution of misbranded drugs. Under the act, any false or misleading labeling is considered “misbranded.” The FDCA further defines misbranding to include instances where “labeling or advertising fails to reveal” material facts about the drug or the potential consequences of its use. 

According to the FDA, the companies’ marketing misbrands certain prescription drugs by either falsely suggesting they are equivalent to FDA-approved products or by failing to disclose limitations of these medications. The disputed claims include statements such as products containing the “same active ingredient as Ozempic and Wegovy,” or “clinically proven ingredients.” The letters instructed many of the companies to, among other actions, stop using this promotional language and comparisons to FDA-approved products.

In an FDA press release from September 9, 2025, the agency expressed concern that patients were not getting a balanced view of information about drug products. After the letters were posted, Hims & Hers Health expressed that it was looking “forward to engaging with” the agency. Both the Hims and Hers websites specifically market their weight-loss plans as affordable options. They also note that compounded drug products are not FDA-approved.

The letters requested companies to respond with plans to address any violations within 15 days.