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

On September 9, 2025, the FDA issued a warning letter to Tuyo Health, Inc. (dba Tuyo Health) following an August 2025 review of the company"s website. The investigation revealed that Tuyo Health is marketing compounded drug products, specifically semaglutide and tirzepatide, using false and misleading claims. The company"s promotional materials suggested that their compounded versions contain the "same active ingredient" as FDA-approved brand-name drugs such as Wegovy, Ozempic, Zepbound, and Mounjaro.

According to the FDA, these claims violate the Federal Food, Drug, and Cosmetic Act (FDCA) because compounded drugs are not FDA-approved. Labeling or advertising that implies a compounded product is identical to an approved drug constitutes misbranding. The FDA emphasized that such practices introduce misbranded products into interstate commerce, which is prohibited under federal law.

Tuyo Health is required to take immediate action to address these violations, including ceasing the use of misleading marketing language and investigating the cause of the non-compliance. The company must provide a written response to the FDA within 15 working days, detailing the specific steps taken to correct the issues and prevent their recurrence. Failure to comply may result in legal action, including product seizures or injunctions.