WASHINGTON, D.C. – Senator Thom Tillis (R-NC) recently sent a letter to Attorney General Bondi, Department of Homeland Security Secretary Noem, and U.S. Food and Drug Administration (FDA) Commissioner Makary expressing concerns over the growing public health threat posed by counterfeit and illegally imported GLP-1 receptor agonist medications.
“FDA-approved GLP-1 therapies such as Ozempic, Wegovy, Mounjaro, and Zepbound have revolutionized the treatment of obesity and Type 2 diabetes for millions of Americans. Unfortunately, the success of and demand for these therapies have also attracted the attention of criminal enterprises seeking to exploit vulnerable patients. Counterfeiters have introduced falsified products into the U.S. market, including counterfeit Ozempic pens bearing fraudulent lot and serial numbers, non-sterile needles, and misleading labeling. These products have even infiltrated legitimate distribution channels, putting patients at risk of receiving contaminated, ineffective, or unsafe medications,” the senator wrote.
“In addition to these finished counterfeits, a recent report from the Partnership for Safe Medicines details a disturbing pattern of illegal importation of unverified semaglutide and tirzepatide APIs from unregistered foreign suppliers, particularly from China. Between 2023 and 2025, 239 shipments of these unapproved APIs were identified, with more than 80% allowed to enter the United States. Shockingly, many shipments were misrepresented as originating from entities such as hotels, fitness centers, and public schools, which raises significant concerns about the legitimacy of these supply chains. It is my understanding that some domestic compounders may have used these APIs during a period when the drugs were in shortage. However, federal regulations require that ingredients be sourced only from FDA-registered manufacturers to ensure compliance with quality and safety standards. With drug shortage resolved, compounding of GLP-1s is now considered unlawful, unless a prescriber determines that a commercially available product cannot meet the specific needs of an individual patient,” the senator continued.
“To that end, I encourage the FDA to expand public and provider education about the dangers of counterfeit and illegally imported GLP-1 products, while also prioritizing enforcement efforts to hold accountable those responsible for introducing these unsafe products into the supply chain. Strengthened collaboration between the FDA, U.S. Customs and Border Protection, and the Department of Justice is essential to prevent these illicit products from reaching patients in the first place. Equally important is providing clear guidance to health care providers and pharmacies to ensure that all medications are sourced exclusively from FDA-registered manufacturers. Finally, the FDA can help restore public confidence by improving transparency around its enforcement actions and ensuring these efforts are clearly communicated to the public,” the senator concluded.
Full text of the letter is available HERE.
###
