FDA WARNING_LETTER - Lean Rx, Inc. dba SkinnyRx - August 01, 2025

The FDA issued a warning letter to Lean Dreams LLC (doing business as LeanDreams) on September 9, 2025, following a review of the company"s website conducted in August 2025. The investigation focused on the marketing of compounded drug products, specifically semaglutide and tirzepatide. The FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act (FDCA), specifically sections regarding misbranded drugs. The main issue stems from promotional claims stating that the company"s compounded products contain the same active ingredients as FDA-approved medications like Ozempic, Wegovy, Mounjaro, and Zepbound. The FDA determined these claims are false or misleading because they incorrectly imply that the compounded versions are equivalent to or have the same approval status as the brand-name drugs. Under the FDCA, compounded drugs are not FDA-approved, and suggesting otherwise in labeling or advertising constitutes misbranding. To resolve these issues, Lean Dreams LLC is required to take immediate action to correct the violations, including ceasing the use of the misleading language. The company must submit a written response to the FDA within 15 working days, detailing the specific steps taken to address the concerns and ensure future compliance. Failure to correct these violations may result in legal action, such as product seizure or injunctions.