FDA WARNING_LETTER - Newman Clinic, PLLC dba Newman Clinic - December 31, 2025

The FDA issued a Warning Letter to Newman Clinic, PLLC dba Newman Clinic on February 20, 2026, following a December 2025 review of its website. The clinic was found to be offering compounded semaglutide and tirzepatide drug products with false or misleading claims, resulting in misbranded drugs being introduced into interstate commerce. The primary violations include misrepresenting Newman Clinic as the compounder of these drugs, which was inaccurate. Additionally, the clinic made claims such as "Same Ingredient as Ozempic® and Wegovy®" and "Same Ingredient as Mounjaro® and Zepbound®," falsely implying that these compounded products were FDA-approved or evaluated for safety and effectiveness, when they are not. These actions violate sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) concerning misbranding, and section 301(a) for introducing such products into interstate commerce. The FDA requires immediate action from Newman Clinic. Within fifteen working days, the clinic must provide a written response detailing specific steps taken to address the violations, including identifying the actual compounders, providing sample labeling, and modifying or removing all false or misleading website claims. Failure to comply may lead to legal action, including seizure and injunction.