FDA WARNING_LETTER - Lyfe Rx - August 31, 2025

The FDA issued a warning letter to Lyfe Rx on September 9, 2025, following a review of their website in August 2025. The inspection revealed that Lyfe Rx offers compounded drug products, specifically semaglutide and tirzepatide, with claims that are considered false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). These claims suggest that the 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 highlighted that compounded drug products are not FDA-approved and that the claims made on Lyfe Rx"s website, such as "Clinically Proven Weight Loss," are misleading. The letter serves as a notice of these violations and emphasizes that it is not an exhaustive list of potential issues. Lyfe Rx is required to investigate and address these violations to prevent recurrence. The company must respond within 15 working days, detailing the steps taken to rectify the issues and prevent future violations. Failure to comply may result in legal actions, including product seizure and injunctions. The FDA also warns that misbranded products may be detained or refused entry into the U.S. if Lyfe Rx is operating internationally.