Healthy Male Warning Letter Details

Summary

Healthy Male was cited for unlawfully selling unapproved and misbranded compounded tirzepatide products through its website, making false or misleading claims that implied the compounded drugs were equivalent to FDA-approved products. The company's marketing statements—including claims that products were "clinically shown to support 15-22% average body weight reduction" and "clinically proven"—violated sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act by misrepresenting compounded drugs as if they held FDA approval status. These violations constituted prohibited acts under section 301(a) of the FDCA, as the compounded products were introduced into interstate commerce with false or misleading labeling and advertising.