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

The FDA issued a Warning Letter to Tuyo Health on September 9, 2025, following a review of their website in August 2025. The inspection revealed that Tuyo Health was marketing compounded drug products, specifically semaglutide and tirzepatide, with misleading claims. These claims suggested equivalence to FDA-approved drugs like Wegovy, Ozempic, Zepbound, and Mounjaro, which is not accurate since compounded drugs are not FDA-approved. This misrepresentation violates sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), resulting in the products being misbranded and their introduction into interstate commerce being prohibited under section 301(a) of the FDCA.

The FDA requires Tuyo Health to take immediate corrective actions, including ceasing the use of misleading language on their website. The company must submit a written response within 15 working days detailing the steps taken to address these violations and prevent future occurrences. Failure to comply may lead to legal actions such as seizure or injunction. Tuyo Health is also advised to provide any reasoning or supporting information if they believe their products are not in violation. Correspondence should be directed to the Office of Compounding Quality and Compliance, with clear identification as a Response to Warning Letter.