FDA WARNING_LETTER - Amazing Meds - August 01, 2025

On September 9, 2025, the FDA issued a warning letter to Amazing Meds following a review of the company’s website in August 2025. The agency identified significant violations of the Federal Food, Drug, and Cosmetic Act (FDCA) related to the marketing of compounded drug products, specifically retatrutide and semaglutide. The FDA determined that the company"s retatrutide products are unapproved new drugs and misbranded. These products fail to meet legal compounding exemptions because retatrutide is not a component of any FDA-approved drug, lacks an official quality monograph, and does not appear on the approved lists of bulk substances for compounding. Additionally, the drug lacks adequate directions for safe use by a layperson, further contributing to its misbranded status. The letter also highlighted false or misleading claims regarding semaglutide. Amazing Meds advertised its compounded semaglutide as being the "same as" the FDA-approved medications Ozempic and Wegovy. The FDA noted that compounded drugs are not FDA-approved, making such comparisons deceptive to consumers. To rectify these issues, the FDA requires Amazing Meds to investigate the root causes of these violations and take immediate corrective actions, such as ceasing the use of misleading marketing language. The company must provide a written response within 15 working days detailing the steps taken to ensure compliance. Failure to address these concerns may lead to legal consequences, including product seizure or an injunction.