FDA WARNING_LETTER - ASN-LABS - August 31, 2025

The FDA issued a warning letter to ASN-LABS on September 9, 2025, following a review of their website in August 2025. The inspection identified significant regulatory violations concerning the marketing of compounded drug products, specifically retatrutide and semaglutide. ASN-LABS was found to be offering unapproved new drugs and misbranded drugs in violation of sections 505(a), 502(f)(1), 301(a), and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA).

Key issues include the failure of retatrutide products to meet the conditions of sections 503A and 503B of the FDCA, as they do not comply with any applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, nor do they appear on the FDA"s approved bulks list. Consequently, these products are not exempt from FDA approval or labeling requirements, rendering them unapproved and misbranded.

Additionally, ASN-LABS made false or misleading claims about their semaglutide products, implying equivalence to FDA-approved drugs like Wegovy and Ozempic. These claims violate sections 502(a) and 502(bb) of the FDCA, as compounded drugs are not FDA-approved and such representations mislead consumers.

The FDA requires ASN-LABS to cease the introduction of these products into interstate commerce and to address the misbranding and approval issues. The letter serves as a formal notice of these violations and demands corrective actions to ensure compliance with federal regulations.