FDA WARNING_LETTER - Premium Health Management Inc. dba Premium Health - December 31, 2025

The FDA issued a Warning Letter to Premium Health Management Inc. dba Premium Health on February 20, 2026, following a December 2025 review of its website. The letter addresses significant violations concerning the company"s offering of compounded semaglutide and tirzepatide drug products. The primary issues involve misbranding, specifically false and misleading claims on the company"s website. Premium Health falsely represented itself as the compounder of these drugs and made deceptive claims implying FDA approval or evaluation of safety and effectiveness for its compounded products, by referring to them as "generic compounded medication" and linking active ingredients to FDA-approved drugs like Ozempic, Wegovy, and Mounjaro.

These actions violate sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) regarding misbranded drugs, and section 301(a) for introducing misbranded products into interstate commerce.

Premium Health is required to respond within fifteen working days, detailing corrective actions taken to address all violations and prevent recurrence. This includes identifying the actual entities compounding the products, providing labeling samples, and either modifying or removing the false and misleading website claims.