FDA launches ‘green list’ to block unsafe imported GLP-1 drug ingredients
The U.S. Food and Drug Administration announced a new “green list” import alert aimed at stopping illegal and potentially dangerous GLP-1 drug ingredients from entering the country.
The move comes amid growing concerns over compounded versions of GLP-1 drugs like semaglutide and tirzepatide, which are often used for type 2 diabetes and weight management but are not FDA-approved in their compounded forms.
The new list will include only those GLP-1 active pharmaceutical ingredients from overseas facilities that have been inspected or evaluated and found to comply with FDA standards. Active pharmaceutical ingredients from any other source may be detained at the border without physical examination.
“Americans should be confident that the prescription drugs they take are safe,” said FDA Commissioner Marty Makary, M.D. “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.”
The FDA has previously warned of serious risks linked to unapproved versions of these drugs, including incorrect dosing, use of unapproved ingredients and adverse health events — some requiring hospitalization.
The agency said it will continue monitoring the market, working with state authorities and taking enforcement actions to prevent unsafe GLP-1 drugs from reaching U.S. consumers.
Read more: FDA
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