FDA WARNING_LETTER - Nuvo Life Health Inc. dba Nuvo Life - August 31, 2025

The FDA issued a Warning Letter to Nuvo Life Health on September 9, 2025, following a review of their website in August 2025. The inspection revealed that Nuvo Life Health was offering compounded drug products, specifically semaglutide and tirzepatide, with claims that are false or misleading. These claims suggest that the compounded products are equivalent to FDA-approved drugs such as Ozempic, Wegovy, and Mounjaro, which they are not. This constitutes a violation under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), leading to the products being misbranded and their introduction into interstate commerce being prohibited under section 301(a) of the FDCA.

The FDA requires Nuvo Life Health to take immediate corrective actions, including ceasing the use of misleading language on their website. The company must respond in writing within 15 working days, detailing the steps taken to address the violations and prevent their recurrence. Failure to comply may result in legal actions such as product seizure or injunction. The FDA also warns that misbranded products may be detained or refused entry into the U.S., and foreign regulatory bodies may be notified. Correspondence should be directed to the Office of Compounding Quality and Compliance, with a clear subject line indicating it is a response to the Warning Letter.