FDA WARNING_LETTER - Strut Health, LLC dba Strut - December 31, 2025

The FDA issued a Warning Letter to Strut Health, LLC dba Strut on February 20, 2026, following a December 2025 review of its website, struthealth.com. The letter addresses significant violations concerning the misbranding of compounded semaglutide and tirzepatide drug products. The primary issues include false or misleading claims suggesting Strut Health is the compounder of these drugs when it is not. Additionally, the company's website made unsubstantiated claims, such as referring to its products as "Generic Zepbound, Mounjaro" and implying FDA approval or evaluation for safety and effectiveness, which is not true for compounded drugs. These actions violate sections 502(a), 502(bb), and 301(a) of the Federal Food, Drug, and Cosmetic Act (FDCA), pertaining to misbranding and the introduction of misbranded products into interstate commerce. Strut Health is required to respond within fifteen working days, detailing steps taken to address the violations. This includes identifying the actual compounders, providing sample product labeling, and modifying or removing all false or misleading claims from its website.