FDA WARNING_LETTER - AMS LLC - August 31, 2025

LeanDreams received a warning letter from the FDA on September 9, 2025, following a review of their website in August 2025. The FDA identified violations related to the marketing of compounded drug products, specifically semaglutide and tirzepatide, which were falsely or misleadingly advertised as equivalent to FDA-approved drugs like Ozempic, Wegovy, Mounjaro, and Zepbound. These claims violate sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), resulting in the products being misbranded and unlawfully introduced into interstate commerce, breaching section 301(a) of the FDCA.

The FDA has mandated LeanDreams to take immediate corrective actions, including ceasing the use of misleading language that implies equivalence to FDA-approved products. The company is required to submit a written response within 15 working days to the Office of Compounding Quality and Compliance, detailing the steps taken to rectify the violations and prevent their recurrence. Failure to comply may lead to legal actions such as product seizure or injunctions.

LeanDreams must ensure compliance with all federal regulations and address any violations promptly. If the company believes their products are not in violation, they must provide supporting information. Non-U.S. entities are advised that misbranded products may face detention or refusal of entry into the U.S. market. Correspondence should be directed to the FDA with a clear subject line indicating it is a response to the warning letter.