NewSelf Limited dba NewSelf – FDA Warning Letter, Dec 31, 2025

On February 20, 2026, the FDA issued a Warning Letter to NewSelf Limited dba NewSelf, following a December 2025 review of their website. The agency observed that NewSelf offered compounded semaglutide and tirzepatide drug products with multiple violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The primary issues involved misbranding under sections 502(a) and 502(bb) of the FDCA, rendering the introduction of these products into interstate commerce a prohibited act under section 301(a). Specifically, NewSelf"s website displayed product labels with "NewSelf," falsely implying the company was the compounder. Furthermore, the website made misleading claims suggesting that their compounded drugs were FDA-approved or evaluated for safety and effectiveness. This was done by stating they contained the "same active ingredient" as FDA-approved medications like Ozempic, Wegovy, Mounjaro, and Zepbound, and referencing the FDA-approved uses of these brand-name products, despite compounded drugs not being FDA-approved. The FDA mandates immediate corrective action. NewSelf must submit a written response to the Office of Compounding Quality and Compliance within 15 working days. This response needs to detail specific steps taken, including identifying the entities that produce the compounded products, providing sample labeling, and modifying or removing all false or misleading website claims. Failure to adequately address these violations may result in further legal action, such as seizure and injunction.