FDA WARNING_LETTER - Public Health and Safety LLC - March 01, 2026

On June 8, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Public Health Solution LLC, operating as DrMedHealth, following a review of the company"s website conducted in March 2026. The FDA identified significant violations regarding the marketing of compounded drug products, specifically semaglutide and tirzepatide. The primary issue involves the use of false or misleading claims, such as stating these products contain the "same active ingredient" as brand-name medications like Ozempic and Mounjaro. These claims incorrectly suggest that the compounded drugs have been FDA-approved or evaluated for safety and effectiveness, which is not the case.

According to the regulatory framework of the Federal Food, Drug, and Cosmetic Act, these products are considered misbranded because their labeling and advertising are deceptive. The FDA noted that the introduction of such misbranded drugs into interstate commerce is prohibited. To address these violations, DrMedHealth is required to investigate the root causes of these issues and implement corrective and preventive measures. The company must provide a written response within 15 business days detailing the steps taken to comply with federal law. Required actions include identifying the entities producing the drugs, submitting representative labeling samples, and documenting the modification or removal of misleading website claims. Failure to adequately address these concerns may lead to legal action, including product seizure or injunctions.