Body Good Studio – FDA Warning Letter, Aug 31, 2025

The FDA issued a Warning Letter to Body Good Studio on September 9, 2025, following a review of their website in August 2025. The FDA identified that Body Good Studio"s website offers compounded drug products, including semaglutide, with claims that are false or misleading under the Federal Food, Drug, and Cosmetic Act (FDCA). Specifically, the website suggests that their compounded semaglutide products are equivalent to FDA-approved drugs like Ozempic and Wegovy, which they are not. This misrepresentation results in the products being classified as misbranded under sections 502(a) and 502(bb) of the FDCA, violating section 301(a) by introducing them into interstate commerce.

The FDA requires Body Good Studio to take immediate corrective actions, including ceasing the use of misleading language. The company must provide a written response within 15 working days detailing the steps taken to address these violations and prevent recurrence. Failure to comply may lead to legal actions such as seizure or injunction. The letter emphasizes that Body Good Studio is responsible for ensuring compliance with all federal laws and FDA regulations. The company is also advised to submit any supporting information if they believe their products are not in violation. Correspondence should be directed to the Office of Compounding Quality and Compliance.