The FDA has taken a significant step against misleading drug advertisements by issuing around 100 warning letters to several pharmaceutical companies, including industry giants like Hims & Hers Health and Eli Lilly. These letters, publicly released on Tuesday, accuse the companies of false advertising on their websites and in electronic promotions, particularly concerning weight-loss medications.

The core of the FDA's accusations lies in the violation of the Food, Drug, and Cosmetic Act (FDCA), which strictly prohibits the distribution of misbranded drugs. According to the FDCA, any drug is considered "misbranded" if its labeling or advertising is misleading or fails to disclose essential information about the drug’s use or limitations. The FDA's concern highlighted in the warning letters includes claims comparing products to FDA-approved drugs like Ozempic and Wegovy, and assertions about "clinically proven ingredients" without adequate substantiation.

In a press release dated September 9, 2025, the FDA expressed its concerns about the potential risks these misleading advertisements pose to consumers, emphasizing the importance of providing a balanced view of drug information. Following the release of the letters, Hims & Hers Health issued a statement indicating their willingness to cooperate with the FDA to resolve the issues.

Both companies, known for marketing their weight-loss solutions as affordable options, have noted on their platforms that compounded drug products they offer are not FDA-approved. This admission aligns with one of the FDA's critical stipulations, which demands clear communication regarding the approval status of marketed drugs.

The companies implicated in these allegations have been given a 15-day window to respond with their plans for rectifying the misleading promotional practices pointed out by the FDA. This action represents a broader effort by the agency to clamp down on deceptive practices in drug advertising, aiming to safeguard consumer interests and ensure the integrity of pharmaceutical marketing.