FDA WARNING_LETTER - Expert Aesthetics - August 01, 2025

On September 9, 2025, the FDA issued a warning letter to Expert Aesthetics following a review of the company"s website in August 2025. The investigation found that the company was marketing compounded semaglutide and tirzepatide products using false and misleading claims. Specifically, the website referred to these products as "generic" versions of brand-name drugs like Ozempic and Mounjaro. The FDA determined these products are misbranded under the Federal Food, Drug, and Cosmetic Act (FDCA) because compounded drugs are not FDA-approved, and labeling them as generics implies they have undergone the same rigorous testing and approval process as their brand-name counterparts. Such claims are illegal and potentially mislead consumers about the safety and efficacy of the drugs. The FDA requires Expert Aesthetics to take immediate action to correct these violations, which includes removing the misleading marketing language. The company must provide a written response within 15 working days explaining the specific steps taken to ensure compliance and prevent future recurrences. Failure to address these concerns may result in legal consequences, including product seizures or injunctions.