FDA WARNING_LETTER - Healthy Living Clinic - August 31, 2025

The FDA issued a warning letter on September 9, 2025, to Healthy Living Clinic, located at 1990 Depew St #140690, Edgewater, CO, following a review of their website in August 2025. The FDA identified that the clinic"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 implies that their compounded semaglutide products are equivalent to FDA-approved products like Wegovy, Ozempic, and Rybelsus, which they are not. This misbranding violates section 301(a) of the FDCA, which prohibits the introduction of misbranded drugs into interstate commerce.

The FDA requires Healthy Living Clinic to take immediate corrective actions, including ceasing the use of misleading language. The clinic must respond within 15 working days to the Office of Compounding Quality and Compliance, detailing the steps taken to rectify the violations and prevent future occurrences. Failure to comply may result in legal actions such as product seizure or injunction. The clinic is also advised that if they disagree with the FDA"s findings, they should provide supporting information. Correspondence should be clearly marked as a Response to Warning Letter, and any questions can be directed to compoundinginspections@fda.hhs.gov.