FDA WARNING_LETTER - ASN-LABS - August 01, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter to ASN-LABS on September 9, 2025, following a review of the company"s website conducted in August 2025. The investigation revealed that the Honolulu-based company is marketing unapproved and misbranded drug products, specifically retatrutide and semaglutide. The primary violations involve the distribution of retatrutide, which the FDA classifies as an unapproved "new drug." Under the Federal Food, Drug, and Cosmetic Act (FDCA), compounded drugs must meet specific criteria to be exempt from standard approval processes. Retatrutide fails these conditions because it is not an active ingredient in any FDA-approved medication, lacks an official quality monograph, and is not included on the authorized lists for pharmacy compounding. Additionally, the FDA found that ASN-LABS made false or misleading claims regarding its semaglutide products. By suggesting these products are the same as approved brand-name medications like Ozempic and Wegovy, the company misleads consumers, as compounded versions have not undergone the same rigorous FDA safety and efficacy review. The FDA further noted that these products lack adequate directions for safe use by non-professionals, contributing to their misbranded status. To resolve these issues, ASN-LABS must immediately correct the violations and ensure all operations comply with federal law. The company is required to submit a written response to the FDA within 15 working days, detailing the specific steps taken to address the concerns and prevent future occurrences. Failure to comply may lead to legal action, such as product seizures or injunctions.