FDA WARNING_LETTER - Nuvo Life Health Inc. dba Nuvo Life - August 01, 2025

The United States Food and Drug Administration (FDA) issued a warning letter to Nuvo Life Health Inc., doing business as Nuvo Life Health, on September 9, 2025. This action followed a review of the company"s website content conducted in August 2025. The primary issue identified by the FDA concerns the marketing and promotion of compounded drug products, specifically semaglutide and tirzepatide. According to the FDA, Nuvo Life Health made false or misleading claims by suggesting its compounded products were equivalent to FDA-approved medications such as Ozempic, Wegovy, and Mounjaro. Because compounded drugs do not undergo the same rigorous FDA approval process as brand-name medications, these comparisons are considered deceptive. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act (FDCA), specifically sections regarding misbranded drugs, these marketing practices are prohibited. The FDA emphasized that implying a compounded drug is identical to an approved product constitutes a violation of federal law. To resolve these issues, Nuvo Life Health must take immediate corrective actions, which include removing the misleading language from its promotional materials and website. The company is required to submit a written response to the FDA within 15 working days. This response must detail the specific steps taken to address the violations and provide a comprehensive plan to prevent future occurrences. Failure to comply may lead to further legal action, such as product seizures or injunctions. This warning serves as a formal notice to ensure the company"s operations align with federal safety and labeling standards.