FDA WARNING_LETTER - Premium Health Management Inc. dba Premium Health - May 01, 2026

On June 8, 2026, the FDA issued a warning letter to Maximus Health, Inc. (doing business as Maximus) following a May 2026 review of the company"s website. The review focused on the marketing of compounded semaglutide and tirzepatide drug products. The FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act, primarily involving false or misleading advertising. The agency noted that Maximus made claims suggesting its compounded drug products were clinically studied or proven for weight loss. These claims are misleading because they imply the products have received FDA approval for safety and effectiveness, which compounded drugs do not undergo. Furthermore, the company falsely claimed its products are sourced from FDA-approved pharmacies; the FDA clarified that it does not approve or license pharmacies or outsourcing facilities. These misrepresentations result in the products being classified as misbranded under federal law. Maximus is required to investigate the root causes of these violations and implement corrective measures to ensure future compliance. The company must provide a written response within 15 business days detailing its corrective actions, identifying the entities producing the drugs, and providing evidence that misleading website claims have been corrected or removed. Failure to address these concerns could result in legal action, such as product seizure or injunctions.