FDA WARNING_LETTER - TRYM Health, Inc. dba TRYM Health - August 31, 2025

The FDA issued a warning letter to TRYM Health on September 9, 2025, following a review of their website in August 2025. The inspection identified that TRYM Health was marketing compounded drug products, specifically semaglutide and tirzepatide, with claims that were deemed false or misleading under the Federal Food, Drug, and Cosmetic Act (FDCA). These claims suggested that the compounded products were equivalent to FDA-approved drugs, which they are not. Consequently, these products were classified as misbranded under sections 502(a) and 502(bb) of the FDCA, violating section 301(a) by being introduced into interstate commerce.

The FDA emphasized that the violations noted are not exhaustive and that TRYM Health is responsible for ensuring compliance with all federal regulations. The company is required to take immediate corrective actions, including ceasing the use of misleading language. TRYM Health must submit a written response within 15 working days detailing the steps taken to rectify the violations and prevent future occurrences. Failure to comply may result in legal actions such as seizure or injunction. The letter also warns that misbranded products may be detained or refused entry into the U.S. if TRYM Health operates internationally. Correspondence regarding this matter should be directed to the FDA"s Office of Compounding Quality and Compliance.