FDA WARNING_LETTER - Vitals RX - August 31, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter to Vitals RX on September 9, 2025, following a review of their website in August 2025. The FDA identified that Vitals RX was offering compounded drug products, specifically semaglutide and tirzepatide, with claims that were false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). These claims suggested that the compounded products were equivalent to FDA-approved drugs, which they are not, thereby misbranding the products and violating section 301(a) of the FDCA.

The FDA highlighted that compounded drugs are not FDA-approved and that the claims on Vitals RX"s website mislead consumers into believing otherwise. The agency emphasized that introducing or delivering these misbranded products into interstate commerce is prohibited under the FDCA.

Vitals RX is required to take immediate corrective actions, including ceasing the use of misleading language on their website. The company must provide 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 future occurrences. Failure to comply may result in legal actions such as product seizure or injunctions. The FDA also warned that if Vitals RX is based outside the U.S., their products could be detained or refused entry into the country.