FDA WARNING_LETTER - Try Nova - August 31, 2025

The FDA issued a warning letter to Try Nova on September 9, 2025, following a review of their website in August 2025. The inspection revealed that Try Nova"s website offers compounded drug products, including semaglutide, with claims that are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). Specifically, the website claims that their compounded semaglutide products contain the "same active ingredient as Wegovy & Ozempic," implying equivalence to FDA-approved products, which is misleading since compounded drugs are not FDA-approved.

This misbranding violates section 301(a) of the FDCA, which prohibits the introduction of misbranded products into interstate commerce. The letter emphasizes that the violations identified are not exhaustive and that Try Nova is responsible for investigating and rectifying these issues to ensure compliance with federal law.

The FDA requires Try Nova to take immediate corrective action, such as ceasing the use of misleading language, and to submit a written response within 15 working days detailing the steps taken to address the violations. Failure to comply may result in legal actions, including product seizure or injunction. Try Nova must also provide documentation of corrective measures and, if applicable, justify why their products are not in violation. Correspondence should be directed to the Office of Compounding Quality and Compliance within the Center for Drug Evaluation and Research.