FDA WARNING_LETTER - ybycmeds - August 01, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter dated September 9, 2025, to the company ybycmeds, based in Sanborn, New York. This action follows an August 2025 review of the company"s website, which revealed significant violations regarding the marketing of compounded drug products containing semaglutide and tirzepatide. The FDA determined that ybycmeds engaged in false and misleading advertising by suggesting its products are equivalent to FDA-approved medications like Ozempic, Wegovy, Mounjaro, and Zepbound. Because compounded drugs are not FDA-approved, these claims misrepresent the nature of the products, leading to violations of the Federal Food, Drug, and Cosmetic Act (FDCA). Under the regulatory framework, these products are considered misbranded, and their distribution in interstate commerce is prohibited. The FDA"s letter mandates that ybycmeds take immediate steps to address these violations, including removing misleading promotional language. The company is responsible for investigating the root causes of these issues and ensuring future compliance with federal regulations. ybycmeds must submit a formal written response within 15 working days detailing the corrective actions taken and providing documentation of these changes. Failure to adequately resolve these concerns may result in further legal action, such as product seizures or injunctions.