FDA WARNING_LETTER - BluefitMD - December 31, 2025

The FDA issued a Warning Letter to BluefitMD on February 20, 2026, following a review of its website content in December 2025. The agency found that BluefitMD is offering misbranded compounded drug products, specifically semaglutide and tirzepatide.

The primary violations involve false and misleading claims on the company"s website. First, the website implies that BluefitMD is the compounder of these drugs, despite not being the actual manufacturer, which misbrands the products. Second, the website makes claims comparing its compounded semaglutide and tirzepatide products to FDA-approved drugs like Ozempic®, Wegovy®, Mounjaro®, and Zepbound® (e.g., "same active ingredient"). These statements falsely suggest that BluefitMD"s compounded products are FDA-approved or have been evaluated for safety and effectiveness, which they have not.

These actions violate the Federal Food, Drug, and Cosmetic Act (FDCA), specifically sections 502(a) and 502(bb) concerning misbranding, and section 301(a) which prohibits the introduction of misbranded drugs into interstate commerce.

BluefitMD is required to take immediate action to correct these violations. The company must provide a written response to the FDA within fifteen working days, detailing the specific steps taken to address the issues and prevent recurrence. This includes identifying the actual compounders of the products, providing representative labeling, and modifying or removing false or misleading website claims. Failure to comply may result in further legal action, including seizure and injunction.