FDA unveils new safeguard in battle over popular weight-loss drugs

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) announced Friday the launch of a new “green list” import alert aimed at blocking unsafe foreign versions of GLP-1 drug ingredients from entering the U.S.

The move is the latest step by the agency to protect patients as demand surges for medications like semaglutide and tirzepatide.

Semaglutide and tirzepatide are prescription medicines used to treat type 2 diabetes and, in some cases, chronic weight management. Semaglutide is sold under brand names like Ozempic and Wegovy, while tirzepatide is sold as Mounjaro and Zepbound. Both drugs work by mimicking natural hormones in the body that help control blood sugar and appetite, which can also lead to weight loss. Tirzepatide is slightly different because it acts on two hormones instead of one, making it even more effective for some patients.

The alert will apply to active pharmaceutical ingredients (APIs) the core components used in the weight loss drugs. Only GLP-1 APIs manufactured at facilities that the FDA has inspected and found compliant with U.S. standards will make the green list, the administration said. Shipments from unverified sources will 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. “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 problems with compounded versions of semaglutide and tirzepatide, including dosing errors, use of unapproved chemical variations and reports of serious side effects, some requiring hospitalization.

George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research, said stopping suspect GLP-1 ingredients before they enter the country is a critical safeguard.

“Our priority is protecting public health by ensuring all active ingredients used in GLP-1 drugs are obtained from compliant manufacturers,” he said. “Targeting illegal foreign GLP-1 active ingredients at the border is a critical part of this work.”

The agency said it will continue to work with state regulators, monitor the drug supply chain and pursue enforcement actions when necessary to prevent unsafe or fraudulent GLP-1 products from reaching patients.

This story was written with the assistance of AI.