FitRX, LLC dba Zealthy – FDA Warning Letter, Aug 31, 2025

The FDA issued a Warning Letter to Zealthy on September 9, 2025, following a review of their website in August 2025. The inspection identified that Zealthy was offering compounded drug products, including semaglutide, with misleading claims. These claims suggested that their compounded semaglutide products were equivalent to FDA-approved drugs like Wegovy and Ozempic, which is false. Under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), these products are considered misbranded due to false or misleading labeling and advertising. Consequently, their introduction into interstate commerce violates section 301(a) of the FDCA.

The FDA requires Zealthy to take immediate corrective actions, including ceasing the use of misleading language on their website. Zealthy must provide a written response within 15 working days, detailing the steps taken to address the violations and prevent recurrence. Failure to comply may lead to legal actions such as seizure or injunction. Zealthy is advised to ensure full compliance with federal laws and FDA regulations. If Zealthy believes their products are not in violation, they must provide supporting information. The FDA also warns that misbranded products may be detained or refused entry into the U.S. if Zealthy is operating internationally.