FDA WARNING_LETTER - FitRX, LLC dba Zealthy - August 01, 2025

On September 9, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to FitRX, LLC, doing business as Zealthy, following a review of the company’s website conducted in August 2025. The regulatory action focuses on the company’s marketing of compounded semaglutide products, which the FDA found to be in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).

The main violations involve false or misleading claims that suggest Zealthy’s compounded semaglutide is identical to FDA-approved medications like Wegovy and Ozempic. The FDA emphasized that compounded drug products are not FDA-approved, and labeling them as having the "same active ingredient" as approved drugs is misleading. Under sections 502(a) and 502(bb) of the FDCA, these products are considered misbranded. Furthermore, introducing these misbranded drugs into interstate commerce is a prohibited act under section 301(a).

Zealthy is required to take immediate action to address these violations, including ceasing the use of the misleading marketing language. The company must submit a written response to the FDA within 15 working days detailing the specific steps taken to correct the issues and prevent their recurrence. Failure to comply may result in legal consequences, such as product seizures or court-ordered injunctions.