FDA Cracks Down on Illicitly Imported GLP-1 Ingredients

The US FDA is cracking down on illegally imported active pharmaceutical ingredients used to make GLP-1 weight loss drugs, despite Novo Nordisk and Eli Lilly already marketing their own GLP-1 obesity therapies. The FDA is targeting ingredients used to make generic versions of these drugs, which are often imported from other countries.

The U.S. Food and Drug Administration (FDA) has recently intensified its oversight of the importation of active pharmaceutical ingredients (APIs) used to produce GLP-1 weight loss drugs. This move comes amidst growing concerns about the safety and efficacy of unapproved compounded drugs that have filled the gap during shortages of patented treatments. The FDA is particularly targeting APIs used to make generic versions of GLP-1 drugs, which are often imported from other countries [1].

Novo Nordisk and Eli Lilly, the manufacturers of GLP-1 obesity therapies Wegovy (semaglutide) and Zepbound (tirzepatide), respectively, have been contending with copycat versions sold on the internet. These compounded versions have been found to pose significant safety risks, including dosing errors, use of unapproved salt forms, and severe side effects, some of which have required hospitalization [2].

To address these issues, the FDA is creating a "green list" of GLP-1 APIs from foreign facilities that it has either inspected or determined to be in compliance with its standards. The agency has emphasized that compounded versions of Novo and Lilly's therapies should only be used when an individual's medical needs cannot be supported by the name-brand drugs. Furthermore, the FDA has sent an import alert to notify customs and other regulatory agencies about the risks associated with these APIs [3].

The FDA's heightened scrutiny of imported GLP-1 drug ingredients is part of a broader effort to ensure the safety and efficacy of medications in the U.S. market. The agency is working to protect consumers from potentially harmful counterfeit or substandard drugs, which could have serious health consequences. By taking these steps, the FDA aims to maintain the integrity of the U.S. drug supply and protect public health.

References:
[1] https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
[2] https://seekingalpha.com/news/4492794-fda-targets-illegal-imported-glp-1-ingredients
[3] https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-tightens-control-over-obesity-drug-ingredient-imports-amid-safety-2025-09-05/