FDA WARNING_LETTER - TRYM Health, Inc. dba TRYM Health - August 01, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to TRYM Health, Inc., doing business as TRYM Health, on September 9, 2025, following an August 2025 review of the company’s website. The FDA found that the company’s promotion of compounded semaglutide and tirzepatide products violated the Federal Food, Drug, and Cosmetic Act (FDCA). The primary issue identified is the use of false or misleading claims. TRYM Health’s marketing suggested its compounded medications were "clinically proven" and contained the exact same active ingredients as FDA-approved brand-name drugs such as Mounjaro, Zepbound, Ozempic, and Wegovy. Under the FDCA, compounded drugs are not FDA-approved, and asserting that they are equivalent to approved products is considered misbranding. These misleading statements resulted in the introduction of misbranded drugs into interstate commerce, which is prohibited under federal law. The FDA has directed TRYM Health to take immediate action to correct these violations, specifically by ceasing the use of the misleading language. The company must provide a written response within 15 working days detailing the specific steps taken to address the issues and prevent their recurrence. Failure to comply with these requirements may lead to further legal consequences, including the seizure of products or court-ordered injunctions. This letter serves as formal notice for the company to ensure all its operations and marketing materials align with federal safety and transparency standards.