FDA WARNING_LETTER - All American Wellness - August 01, 2025

On September 9, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to All American Wellness regarding its marketing of compounded drug products. Following a review of the company"s website in August 2025, the FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The primary issue involves the sale and promotion of compounded semaglutide and tirzepatide. The FDA determined that All American Wellness engaged in misbranding by using false or misleading claims in its advertising. Specifically, the company promoted its products as "compounded versions" of the FDA-approved medications Ozempic and Mounjaro. Because compounded drugs do not undergo the same FDA approval process as brand-name medications, these marketing claims erroneously imply that the products are identical to their approved counterparts. Under the regulatory framework of the FDCA, drugs are considered misbranded if their labeling or promotion is misleading in any way. Introducing such products into interstate commerce is a prohibited act. The FDA has directed All American Wellness to take immediate action to correct these violations, including removing the misleading language from its marketing materials. The company is required to provide a written response within 15 working days detailing the specific steps taken to address the issues and prevent their recurrence. Failure to comply may result in legal action, such as product seizures or injunctions.