Getting the Green Light: FDA's New Safeguards for GLP-1 Imports

On September 5, 2025, the U.S. Food and Drug Administration (FDA) announced the establishment of a "green list" import alert (Import Alert 66-80) designed to prevent unverified glucagon-like peptide-1 (GLP-1) active pharmaceutical ingredients (APIs) from entering the U.S. market. This initiative targets imports of GLP-1 APIs, such as those used in products like semaglutide and tirzepatide, which are used to treat type 2 diabetes and chronic weight management, from unverified foreign sources.

Key Details 

The green list identifies GLP-1 API manufacturers that the FDA has inspected or evaluated and appear to be compliant with U.S. manufacturing standards. APIs from these "green-listed" facilities are exempt from detention without physical examination (DWPE) at the border. All other GLP-1 APIs from unverified foreign sources may be subject to automatic detention.

According to the announcement, the FDA will continue monitoring the market, collaborate with state regulators, and pursue enforcement actions against unsafe or fraudulent products.