FDA WARNING_LETTER - Healthon Inc. dba Healthon - August 31, 2025

The FDA issued a warning letter to Healthon, located at 100 Spectrum Center Dr #900, Irvine, CA, on September 9, 2025, following a review of their website in August 2025. The review identified misleading claims about compounded drug products, specifically semaglutide and tirzepatide. These claims violate sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), as they falsely imply equivalence to FDA-approved products, thus misbranding the drugs. This misbranding leads to violations of section 301(a) of the FDCA, which prohibits the introduction of misbranded drugs into interstate commerce.

The FDA requires Healthon to take immediate corrective actions, including ceasing misleading advertising and ensuring compliance with federal law. Healthon must submit a written response within 15 working days, detailing steps taken to address the violations and prevent recurrence. Failure to comply may result in legal actions such as seizure or injunction. The letter emphasizes that the identified issues are not exhaustive, urging Healthon to investigate further potential violations. Correspondence should be directed to the Office of Compounding Quality and Compliance within the FDA"s Center for Drug Evaluation and Research.