FDA WARNING_LETTER - Aspen Aesthetics dba Fifty 410 - December 31, 2025

The FDA issued a Warning Letter to Aspen Aesthetics, operating as Fifty 410, on February 20, 2026, following a December 2025 review of their website. The agency found that Fifty 410 offered misbranded compounded semaglutide and tirzepatide drug products. Key violations included false and misleading claims on their website. Specifically, the company's website falsely suggested that Fifty 410 was the compounder of these drugs, which was incorrect. Additionally, the claim "clinically proven ingredients" for these compounded products was deemed misleading because compounded drugs are not FDA-approved and have not been evaluated for safety and effectiveness in the same way as approved drugs. These actions constitute misbranding under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), and the introduction of such misbranded products into interstate commerce violates section 301(a) of the FDCA. The FDA requires Fifty 410 to take immediate action. Within fifteen working days, the company must provide a written response outlining specific steps taken to address these violations, including identifying the actual compounders, providing product labeling, and either modifying or removing the misleading website claims. Failure to comply may result in further legal action.