FDA WARNING_LETTER - Lean Rx, Inc. dba SkinnyRx - December 31, 2025

The FDA issued a Warning Letter to Lean Rx, Inc. dba SkinnyRx on February 20, 2026, following a December 2025 review of its website, skinnyrx.com. The agency identified significant violations concerning the company’s compounded semaglutide and tirzepatide drug products. The main issues include the misbranding of these products, in violation of sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). SkinnyRx’s website falsely indicated that it was the compounder of these drugs. Furthermore, the site featured misleading claims, such as stating the products contained "the same active ingredient as FDA-approved medications," which falsely implied that these compounded drugs were FDA-approved or had undergone similar safety and effectiveness evaluations. The introduction of these misbranded products into interstate commerce constitutes a prohibited act under section 301(a) of the FDCA. The FDA mandates immediate corrective action from SkinnyRx. The company must provide a written response within fifteen working days, detailing specific steps to address all violations and prevent their recurrence. Required actions include identifying the actual entities compounding the products, submitting representative labeling samples, and modifying or removing all false or misleading claims from its website. Failure to comply may result in further legal actions, such as product seizure and injunction.