FDA WARNING_LETTER - All American Wellness - August 31, 2025

The FDA issued a warning letter to All American Wellness on September 9, 2025, following a review of their website in August 2025. The inspection revealed that the company offers compounded drug products, including semaglutide and tirzepatide, with claims that are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). These claims suggest that the compounded products are equivalent to FDA-approved drugs, which they are not, resulting in the products being misbranded and introduced into interstate commerce in violation of section 301(a) of the FDCA.

The FDA requires All American Wellness to take immediate corrective actions, including ceasing the use of misleading language that implies FDA approval. The company must provide a written response within 15 working days to the Office of Compounding Quality and Compliance, detailing the steps taken to address the violations and prevent recurrence. Failure to comply may lead to legal actions such as seizure and injunction. The letter also advises that if the company believes their products are not in violation, they should provide supporting information for FDA consideration. Correspondence should be clearly marked as a Response to Warning Letter, and any questions should be directed to the FDA"s specified contact email.