FDA WARNING_LETTER - Slendid - August 01, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter to Slendid on September 9, 2025, following a review of the company"s website conducted in August 2025. The investigation focused on Slendid"s marketing and distribution of compounded drug products, specifically semaglutide and tirzepatide. The FDA identified a primary violation involving the claim "Clinically proven weight loss treatments" displayed on the company’s website. The agency determined this statement to be false or misleading because compounded drug products do not undergo the same FDA approval process as brand-name medications. By using this language, Slendid implies its products are equivalent to FDA-approved drugs, which constitutes misbranding under Sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). Introducing these misbranded products into interstate commerce is a violation of federal law. Slendid is required to take immediate action to address these violations, including ceasing the use of the misleading marketing language. The FDA has mandated a written response within 15 working days detailing the specific steps taken to correct the issues and prevent their recurrence. Failure to adequately address these concerns may result in legal action, such as product seizures or injunctions. The company is ultimately responsible for ensuring all operations comply with federal safety and labeling regulations.