FDA Works with Homeland Security to Prevent Illegal Drug Imports

FDA announced on Oct. 30, 2020 that the agency has signed a Memorandum of Understanding (MOU) with US Customs and Border Protection (CBP) and the US Immigration and Customs Enforcement, Homeland Security Investigations (ICE–HSI) to maximize inspection and detection capabilities to prevent illegal products from entering the United States through International Mail Facilities (IMFs). The collaboration will target illicit opioids, including fentanyl and other unapproved or unlawful drugs, medical devices, and dietary supplements regulated under the Federal Food, Drug, and Cosmetic Act. FDA stated in the press release that the collaboration between the agencies is “critical” in intercepting counterfeit, fraudulent, or illegitimate COVID-19 products. The agencies will share information, facilities, and coordinated operations.

“Americans must have confidence that the products they receive are reliable and fully comply with US laws,” said FDA Commissioner Stephen M. Hahn, M.D., in the press release. “The collaborative efforts we’ve announced will enable more resourceful, effective, and efficient oversight to prevent illegal and potentially harmful products from entering the United States—thereby aiding our essential mission to protect the health and safety of the American people. We remain committed to using all tools and authorities available and leveraging our strong relationship with our federal partners to help stop the illegal flow of counterfeit and unapproved medical products into our country.”

In April 2019, FDA and CBP signed a letter of intent for inspection and detection at IMFs, and the recent MOU expands the types of information shared among the agencies. “This collaboration involves sharing of both general and specific data points, which can be used to target impending product entries and to inform future enforcement strategies. An additional focus of this effort will be coordinating shared space as well as increased scientific presence at high-volume IMF locations, helping to facilitate and support real-time entry decisions and increased data sharing,” FDA stated.