FDA WARNING_LETTER - JulyMD - August 01, 2025

On September 9, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to JulyMD following a review of the company"s website in August 2025. The review identified significant violations concerning the promotion of compounded semaglutide products, which are used for weight loss and type 2 diabetes management. The FDA determined that JulyMD"s marketing materials contained false or misleading claims. Specifically, the website suggested that its compounded semaglutide products are identical to FDA-approved medications like Wegovy and Ozempic. Because compounded drugs do not undergo the same FDA approval process as brand-name medications, implying such equivalence is considered a violation of the Federal Food, Drug, and Cosmetic Act (FDCA). Under this regulatory framework, the products are classified as misbranded because their labeling and advertising are deceptive. To resolve these issues, the FDA requires JulyMD to take immediate corrective actions, including removing the misleading claims from its website and ensuring all future operations comply with federal law. The company must investigate the root causes of these violations to prevent them from happening again. JulyMD is required to submit a written response to the FDA within 15 working days, detailing the specific steps taken to address the violations and providing documentation of these changes. Failure to comply may lead to legal consequences, such as product seizures or court injunctions.