FDA WARNING_LETTER - Healthon Inc. dba Healthon - August 01, 2025

Healthon Inc., doing business as Healthon, received a warning letter from the FDA on September 9, 2025, following a review of its website in August 2025. The agency determined that the company’s marketing for compounded semaglutide and tirzepatide products—often used for weight loss—contained false or misleading information. Specifically, Healthon claimed its products used the "same active ingredient" as popular FDA-approved medications like Ozempic, Wegovy, Mounjaro, and Zepbound. It also incorrectly stated that its ingredients were FDA-approved. Because compounded drugs do not undergo the same rigorous approval process as brand-name medications, these claims misrepresent the products" regulatory status. Under the Federal Food, Drug, and Cosmetic Act, these misrepresentations classify the products as misbranded. The FDA has instructed Healthon to immediately cease using this misleading language and to investigate all potential violations within its operations. The company must provide a written response within 15 working days detailing the specific steps taken to correct the issues and prevent them from happening again. Failure to comply with these requirements could result in legal action, including product seizures or court-ordered injunctions.