FDA WARNING_LETTER - MyStart Health LLC - August 01, 2025

On September 9, 2025, the FDA issued a warning letter to MyStart Health LLC following a review of the company’s website in August 2025. The regulatory agency found that the company was marketing compounded semaglutide using false and misleading claims. Specifically, the website referred to its products as "Generic Ozempic" and suggested they offered the same active ingredients and results as the FDA-approved version. Because compounded drugs do not undergo the same FDA approval process as brand-name medications, the FDA determined these claims were deceptive, making the products misbranded under the Federal Food, Drug, and Cosmetic Act. The FDA emphasized that it is illegal to distribute misbranded drugs across state lines. The letter serves as formal notice that the company must immediately address these violations to comply with federal law. MyStart Health LLC is required to submit a written response within 15 working days detailing the corrective actions taken to resolve the issues and the procedures implemented to prevent future occurrences. Failure to rectify these violations promptly may lead to legal action, including product seizures or injunctions.