The U.S. Food and Drug Administration (“FDA”) announced the launch of its “Green List” initiative designed to protect consumers from illegally imported GLP-1 drug ingredients—such as semaglutide and tirzepatide—on September 5, 2025. According to FDA, these measures aim to curb the influx of counterfeit, substandard, and unapproved GLP-1 products entering the U.S. market.
Pursuant to Import Alert 66-80, the FDA has created a “Green List” of foreign manufacturers that have demonstrated compliance with U.S. drug safety standards.Only firms on this list will be permitted to import GLP-1 active pharmaceutical ingredients (“APIs”) into the United States.[1] The import alert empowers FDA field personnel to detain, without physical examination, shipments of GLP-1 APIs from unapproved foreign sources not included on the “Green List.”
This initiative appears to be part of a broader strategy to prevent the distribution of unsafe or misbranded GLP-1 products, which FDA states have been linked to dosing errors, contamination, and adverse health outcomes. It also may be in response to, among other things, a letter sent to FDA on July 25, 2025 by a bi-partisan group of 81 legislators asking the FDA to respond to “a surge in illegal and counterfeit anti-obesity medications (“AOMs”), which include semaglutide and tirzepatide, entering the United States from unregistered foreign entities.” Going forward, compounders and other affected stakeholders must ensure that their API is sourced from FDA-approved manufacturers listed on the Green List and ensure compliance with Import Alert 66-80.
How Blank Rome Can Help
Blank Rome’s multidisciplinary team is closely monitoring these developments and is well-positioned to assist healthcare providers, pharmacies, and businesses navigating the evolving regulatory landscape surrounding GLP-1 drugs. We offer comprehensive support in compliance, risk management, government investigations, litigation, and crisis response. Our experience with state and federal enforcement actions ensures that clients receive proactive guidance to mitigate risk and protect their operations.
For more information on how Blank Rome can support your organization in this rapidly changing environment, please contact Rachael G. Pontikes, Emily L. Hussey, Susan J. Dewey, Amica J. Nesbitt, Kelly J. Kearney, and Garrison B. Ambrose or another member of our Healthcare industry team or Shannon E. McClure and Michael F. Reeder of the Business Litigation group.
[1] The publicly available alert currently redacts the names of the manufacturers included on the Green List. The Blank Rome team will continue to monitor this for updates if/when the names become publicly available.
