The US Food and Drug Administration (FDA) has created a new “green list” import alert to stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the US market.

The move is part of the agency’s decisive steps to safeguard consumers from illegal GLP-1 active ingredients imported from overseas and to ensure a secure drug supply chain.

Certain GLP-1 drugs, including semaglutide and tirzepatide, are FDA-approved for specific uses such as treating type 2 diabetes and, in certain cases, chronic weight management. However, some patients are turning to compounded versions of these drugs, which are not approved by the agency.

The FDA previously identified serious concerns with compounded versions of semaglutide and tirzepatide, including dosing errors, use of unapproved salt forms, and adverse events—some requiring hospitalisation.  

To address these risks, the FDA’s green list will include GLP-1 APIs from facilities that the agency has inspected or evaluated and found to be compliant with its rigorous standards – standards applicable to all APIs manufactured in the US. APIs from other sources will be detained without physical examination.     

“By strengthening oversight of imported APIs and cracking down on illegal drugs entering the US, we are taking aggressive action to protect consumers from poor-quality or dangerous GLP-1 drugs,” said FDA Commissioner Marty Makary.

“Our priority is protecting public health by ensuring all active ingredients used in GLP-1 drugs are obtained from compliant manufacturers. Targeting illegal foreign GLP-1 active ingredients at the border is a critical part of this work,” said George Tidmarsh, Director of the FDA’s Center for Drug Evaluation and Research.

The agency said that it will work with state regulators, monitor the market, and take enforcement actions as necessary to prevent unsafe or fraudulent GLP-1 drugs from reaching US consumers.