FDA, Homeland Security Agencies Take Additional Action to Prevent Import of Illegal and Harmful Medical Products Through International Mail Facilities
Recently, leadership from the U.S. Food and Drug Administration, the U.S. Customs and Border Protection (CBP), and the U.S. Immigration and Customs Enforcement, Homeland Security Investigations (ICE-HSI) signed a Memorandum of Understanding (MOU) to stop harmful products that pose a threat to public health and attempt to enter the U.S. through International Mail Facilities (IMFs). The MOU will maximize inspection and detection capabilities in order to prevent this illegal activity.
As a core part of this collaborative effort, CBP and ICE-HSI will continue to partner with the FDA in joint operations at the IMFs to 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. This partnership is also critical in our continuing efforts to intercept fraudulent, counterfeit or illegitimate COVID-19 products that may pose risks to public health. Additionally, the agencies will work to coordinate ongoing activities through collaborative information sharing, shared facilities, and future coordinated operations.
“Americans must have confidence that the products they receive are reliable and fully comply with U.S. laws,” said FDA Commissioner Stephen M. Hahn, M.D. “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.”
“International mail and express consignment are major conduits for drug smugglers. This has become more challenging for law enforcement as volumes have skyrocketed, and because of e-commerce and rapid shipping logistics,” said CBP Acting Commissioner Mark A. Morgan. “This partnership with FDA and ICE will ensure a whole-of-government approach that will provide additional resources and tools to disrupt these dangerous drugs from reaching our communities.”
“FDA and CBP are key partners in our mission to protect against counterfeit goods that could cause harm,” said Senior Official Performing the Duties of the Director Tony H. Pham. “ICE HSI special agents investigate and enforce violations of federal trademark, copyright and patent law and work to dismantle counterfeit operations and hold individuals involved in them accountable – mitigating risks to legitimate business and ensuring public safety.”
The FDA and CBP signed a letter of intent in April 2019, to maximize inspection and detection capabilities at the IMFs. As outlined in the letter of intent and in the recently signed MOU, the FDA, CBP, and ICE-HSI will expand the types of information and how that information is shared among the agencies to quickly and effectively identify trends in incoming violative packages. 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.
Since April 2016, when the FDA implemented its administrative destruction authority at all nine IMFs, the agency has destroyed more than 12.9 million capsules/tablets/pieces – weighing over 41.2 tons. The destruction of almost 13 million violative drug units by the FDA represents a key component of the agency’s public health mission, as these potentially dangerous drugs were destined for over 31,000 U.S. consumers. New authorities and resources provided by Congress under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act have enabled the FDA to create a more efficient destruction process for violative drugs containing certain active pharmaceutical ingredients (APIs), and to expand its presence at IMF locations nationwide, which has resulted in more rapid, on-site scientific support, increased staffing and improved work facilities.
In fiscal year (FY) 2019, the FDA screened approximately 25,200 parcels containing more than 41,000 products at its IMF facilities. The agency subsequently refused to admit more than 35,000 of those products and nearly half (over 17,000 products) were identified as violative drugs and destroyed using FDA’s administrative destruction authority. So far in FY 2020, the FDA has screened approximately 27,500 mail parcels, containing almost 43,000 FDA-regulated products. Of these products, more than 34,000 were refused admission and more than 24,000 were violative drug products that have been destroyed.