FDA launches import alert to block illegal GLP-1 drug ingredients from entering US

The U.S. Food and Drug Administration (FDA) has created a “green list” import alert to stop potentially unsafe glucagon-like peptide-1 (GLP-1) active pharmaceutical ingredients (APIs) from entering the U.S. market. The agency said the list will identify foreign manufacturers that meet FDA standards, while APIs from unverified sources will face detention without physical examination.

GLP-1 drugs such as semaglutide and tirzepatide are FDA-approved for type 2 diabetes and chronic weight management uses. However, the agency said some patients are using compounded versions, which are not FDA-approved and have raised safety concerns.

FDA officials said the agency has already identified risks with compounded GLP-1 products, including dosing errors, use of unapproved salt forms and adverse events requiring hospitalization. The green list aims to ensure that all APIs used in compounded versions of GLP-1 drugs come from compliant sources.

“This import alert does not apply to GLP-1 API from manufacturers that, based on an FDA inspection or other FDA evaluation, appear to be in compliance with FDA’s rigorous standards for manufacturing practices,” according to the regulator.

The agency said it will continue monitoring the market, working with state regulators, and taking enforcement actions as needed to prevent unsafe GLP-1 drugs from reaching U.S. consumers.

“Americans should be confident that the prescription drugs they take are safe,” FDA Commissioner Marty Makary said in a statement. “By strengthening oversight of imported APIs and cracking down on illegal drugs entering the U.S., we are taking aggressive action to protect consumers from poor-quality or dangerous GLP-1 drugs.”