FDA WARNING_LETTER - SimpleRx - August 01, 2025

On September 9, 2025, the FDA issued a warning letter to SimpleRx, located in Bellevue, Kentucky, following an August 2025 review of the company’s website. The agency identified significant violations regarding the marketing of compounded semaglutide and tirzepatide products. SimpleRx is accused of using false and misleading claims that imply their compounded products are identical to FDA-approved drugs such as Ozempic and Zepbound. The company also incorrectly labeled certain items as "generic" versions of approved medications. Under the Federal Food, Drug, and Cosmetic Act, compounded drugs are not FDA-approved, and marketing them in a way that suggests equivalence to approved products constitutes misbranding. The FDA emphasized that these misleading promotions violate federal regulations governing the introduction of drugs into interstate commerce. SimpleRx is required to take immediate action to address these violations, including ceasing the use of the cited misleading language. The company must provide a written response to the FDA within 15 working days, detailing the corrective measures taken and explaining how they will prevent future occurrences. Failure to comply could lead to legal actions, including product seizures or injunctions.