FDA WARNING_LETTER - Vitals RX - August 01, 2025

On September 9, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to Vitals RX following a review of the company’s website conducted in August 2025. The agency found that the company was marketing compounded drug products, specifically semaglutide and tirzepatide, using false and misleading claims. The primary issue identified was that Vitals RX’s advertising suggested its compounded products were the same as FDA-approved medications, such as Ozempic. Since compounded drugs do not undergo the same FDA approval process as brand-name medications, these representations are considered deceptive. Under the Federal Food, Drug, and Cosmetic Act, these products are classified as misbranded, and their distribution in interstate commerce is a violation of federal law. The FDA has mandated that Vitals RX take immediate action to correct these violations, including removing the misleading claims. The company is required to provide a written response within 15 working days detailing the specific corrective measures taken and the steps implemented to prevent future recurrences. Failure to resolve these issues promptly may result in further legal action, such as product seizures or injunctions.