FDA In Brief: Readout of Acting FDA Commissioner Ned Sharpless, M.D., Visit to JFK/Secaucus International Mail Facilities

October 9, 2019

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“It is truly remarkable to have witnessed the stunning volume of parcels that come into a single international mail facility on any given day. FDA investigators are on the front lines at these points of entry and, through an impressive collaboration with our Customs and Border Protection colleagues and other federal partners, we’re able to maximize the ability to inspect and detect suspect packages coming through these IMFs. Many of these parcels lack any package labeling, contain products labeled as dietary supplements with hidden drug ingredients, or contain drug products or medical devices that are unapproved or counterfeit. I commend the hard-working men and women who play a pivotal role working around the country in support of our essential mission to protect the health of the American people,” said Acting FDA Commissioner Ned Sharpless, M.D. “From my visit today to two of these facilities, I was able to see first-hand how unapproved, counterfeit and substandard products can be detected and uprooted before they can cause harm. These activities are essential to our ongoing work protecting Americans from unapproved or counterfeit regulated goods – especially as we work with CBP agents to identify potentially illicit vaping products amid the recent reports of lung injuries. This work may provide a mechanism to start following the supply chain to the source of these concerning lung illnesses. We’re grateful for the support provided by Congress that allows us to continue investing in these imperative efforts and supports our ability to implement smarter, modern detection efforts. We remain steadfast in our commitment to protect American consumers from illegal and potentially dangerous products.”

On Oct. 8, Acting U.S. Food and Drug Administration Commissioner Ned Sharpless, M.D., visited two international mail facilities (IMFs) to see the critical work being carried out by agency investigators in the FDA’s effort to combat overseas shipments containing illicit and potentially dangerous drugs and other products from reaching Americans: the IMFs at JFK Airport in Jamaica, New York and Secaucus, New Jersey. The nine IMFs across the U.S. receive mail from more than 180 countries, and it is part of the FDA’s mission to inspect, detect and intercept illegal products, including those that are unapproved, counterfeit and/or potentially dangerous, such as illicit opioid products, counterfeit prescription drugs, medical devices, over-the-counter products, and products labeled as dietary supplements that may contain harmful ingredients. In addition, amid more than 1,000 reports of lung injuries associated with vaping use, FDA investigators and special agents are collaborating with Customs and Border Protection (CBP) agents to identify potentially illicit vaping products at these entry locations.

New authorities and resources provided by Congress have enabled the FDA to expand its presence at IMF locations nationwide, which has resulted in more rapid, on-site scientific support, increased staffing and improved work facilities. For example, since May 2017, after new authorities went into effect, the FDA has exercised its administrative destruction authority at the JFK IMF and destroyed more than 3.7 million capsules/tablets – weighing 16.58 tons – of illicit and potentially dangerous drugs. In fiscal year 2019, the FDA screened approximately 25,200 parcels, containing more than 41,000 products, combined at all of its IMF facilities. The FDA detained more than 38,000 of those products, and we expect to ultimately destroy more than 17,000 of those products as drugs subject to the FDA’s Administrative Destruction Authority.

Acting FDA Commissioner Ned Sharpless, M.D., Visit to JFK/Secaucus International Mail Facilities

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.