Healthy Male – FDA Warning Letter, Aug 31, 2025

The FDA issued a warning letter to Healthy Male, located at 5801 S. McClintock Drive, Suite 107, Tempe, AZ, on September 9, 2025, following a review of their website in August 2025. The inspection revealed that Healthy Male"s website offers compounded drug products, including tirzepatide, with claims that are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). These claims suggest that the products are equivalent to FDA-approved medications, which they are not, thus misbranding them.

The FDA highlighted specific misleading claims on Healthy Male"s website, such as assertions that their compounded tirzepatide products are "clinically shown to support 15-22% average body weight reduction" and "clinically proven to deliver sustainable results." These statements imply FDA approval, which is not the case, leading to violations of sections 502(a) and 502(bb) of the FDCA.

The FDA requires Healthy Male to take immediate corrective actions, including ceasing the use of misleading language and ensuring compliance with federal regulations. The company must respond in writing within 15 working days, detailing the steps taken to address these violations and prevent recurrence. Failure to comply may result in legal actions, including product seizure and injunctions. Healthy Male is advised to communicate any delays in addressing these issues and provide a timeline for resolution. Correspondence should be directed to the Office of Compounding Quality and Compliance.