FDA WARNING_LETTER - HealBerry - August 01, 2025

On September 9, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to HealBerry, a company based in Beverly Hills, California, following a review of its website in August 2025. The agency’s investigation focused on the marketing of compounded drug products, specifically semaglutide. The FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act (FDCA) regarding how these products are advertised. The primary issue cited is the use of false or misleading claims, such as stating that their compounded semaglutide contains the "same active ingredient as Ozempic and Wegovy." The FDA clarified that such claims are deceptive because compounded drugs are not FDA-approved, and implying they are identical to approved brand-name medications constitutes misbranding. Under the regulatory framework, selling misbranded drugs in interstate commerce is illegal. HealBerry is required to take immediate corrective actions, including ceasing the use of the misleading language. The company must conduct a thorough review of its operations to ensure compliance with federal law and prevent future violations. A formal written response is required within 15 working days, outlining the specific steps taken to address the FDA"s concerns. Failure to comply may lead to legal enforcement actions, such as product seizures or injunctions.