U.S. Food and Drug Administration 

and the 

International Mail Facilities

The fight to keep illegal, unapproved, counterfeit and potentially dangerous drugs 

from entering the United States

Updated April 2019
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The FDA’s presence at the International Mail Facilities (IMF) helps provide a front line 

defense against illegal, unapproved, counterfeit and potentially dangerous drugs from 

entering the United States. With staff assigned to all nine IMFs throughout the U.S., Puerto 

Rico and the U.S. Virgin Islands, FDA investigators are responsible for monitoring mail 

importations of FDA regulated products by conducting comprehensive examinations of 

packages suspected to contain drugs to determine if those drugs should be refused delivery 

to the U.S. consumer. 

www.fda.gov Packages for FDA review at JFK IMF

IMF locations:

• Los Angeles, CA

• San Francisco, CA

• Doral, FL

• Honolulu, HI

• Chicago, IL

• Jamaica, NY

• Jersey City, NJ

• Hato Rey, Puerto 

Rico

• St. Thomas, U.S. 

Virgin Islands 
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The IMFs receive international mail from more than 180 countries, which often lack 

advance information regarding the content of the packages that would aid in targeting 

shipments that are likely to contain illegal, unapproved, counterfeit and potentially 

dangerous drugs. How large is the scope of the problem? There’s no way for the FDA 

or any federal agency to know. But 87% of the packages that the FDA has reviewed 

contain illegal, unapproved, counterfeit and potentially dangerous drugs.

www.fda.gov

Packages for FDA review at JFK IMF

Hormones found at JFK IMF
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Packages that are sent through private carriers require the submission of electronic data that helps 

Customs and Border Protection (CBP) target specific dangerous shipments, helping to intercept illicit and 

illegal drugs. However, most foreign postal services do not currently provide advance electronic 

information (AEI) on international mail shipments, a vulnerability that is increasingly exploited by bad 

actors. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for 

Patients and Communities Act (SUPPORT Act), signed into law on October 24, 2018, requires that, by 

December 31, 2020, AEI be submitted for all international mail shipments.

www.fda.gov

Packages for FDA review at JFK IMF Numerous individual packages from single supplier
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Compounding the problem is the hazardous nature of various types of synthetic drugs 

that are being sent through the IMFs. Processing inbound international mail is 

primarily a manual process and requires CBP officers to sort through large bags and 

bins by hand. At the IMFs, FDA investigators open and examine packages flagged for 

screening by CBP. Given the sheer volume of mail—and the amount of time it takes to 

inspect just one package—this is a challenging task.

www.fda.gov Packages for FDA review at JFK IMF
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At the IMFs, the FDA is asked to examine the packages pulled by CBP and believed to 

contain FDA-regulated products. In fiscal year 2017, the IMFs received an estimated 

275 million packages. Of these, the FDA estimates that approximately 9% of them 

contained drugs of some kind. In FY19, the FDA plans to screen approximately 45,000 

packages after recently increasing staffing to full capacity at the IMFs. Previously, the 

FDA was inspecting between 10,000-20,000 packages annually. With additional 

resources, we hope to increase that number to 100,000 packages per year.

www.fda.gov

Unmarked, unlabeled capsules at JFK

Various loose blister packs 
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It’s estimated that the FDA is able to inspect less than 0.18% of the packages 

assumed to contain drug products that are shipped through the international 

mail facilities. 

www.fda.gov

•In 2017, USPS's inbound international mail topped 275 million pieces, an 275,000,000 increase of 232% between 2013 and 2017.

•Across all modes of entry and all FDA-regulated products, the FDA receives 

over 43 million import lines per year. FDA has seen a 10% increase in 43,000,000 imports every year for more than a decade.

•In FY18, across all 9 IMF locations, FDA reviewed 10,231 mail entries 20,117 (parcels), which contained 14,995 lines of product. 

•In FY17, 86% of the packages FDA screened contained drugs. In FY18, this 87 number has grown slightly to appx. 87% of packages to-date.

22 •FDA has 22 Import Investigators to cover the 9 IMF locations.

•FDA has 12 Office of Criminal Investigations Port of Entry Special Agents to 12 cover the 9 IMFs and other Ports of Entry.
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The investigation process takes time. An experienced FDA investigator can process a 

package containing a single product in about 20 minutes. This time can increase if a 

package contains multiple products, if the product is unlabeled or if the product is labeled in 

a language other than English. This estimate only includes work conducted by the FDA 

investigator in the IMF and does not include the amount of time required to detain the 

suspect package and work through the detention and hearing process leading to a final 

admissibility determination. To lessen the time spent by FDA investigators on multiple 

shipments of illegal drugs by the same person, the SUPPORT Act gave FDA authority to treat 

any shipments of drugs from a person as illegal after FDA has determined that such person 

is engaging in a pattern of illegally importing adulterated or misbranded drugs from the 

same manufacturer, distributor, or importer. 

www.fda.gov

Single mail parcel containing appx. 3,200-4,000 tablets of suspected 

counterfeit Cialis after being screened using the CD3 Counterfeit 

Detector. 
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When a product lacks proper labeling, the FDA needs to act quickly to determine if a 

product should be detained, so a creative approach is needed. To enable faster 

decisions, the agency employs a variety of tools, including one that can determine if a 

drug is a counterfeit, one that can determine if a product contains undeclared drugs 

and another that uses the same technology as airport security to swipe your luggage 

for explosives. The FDA is actively working on developing an opioid screening method 

and intends to initiate a pilot study using this method at the IMFs soon. Additionally, 

the SUPPORT Act gave FDA authority to treat an article as a drug if it includes an active 

ingredient in an FDA-approved drug or licensed biologic, or an analogue of that active 

ingredient, and the ingredient presents a significant public health concern. This new 

authority will help FDA refuse and destroy illegal and potentially dangerous drugs that 

are unlabeled or mislabeled. 

www.fda.gov

Testing a dietary supplement using a benchtop ion mobility spectrometer

Preparing test sample for ion mobility 

spectrometer analysis

CD-3, counterfeit detection device
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Thousands of the packages entering through the IMFs contain what appear to be FDAregulated products. These packages include unapproved products; counterfeit or 

substandard drugs; purported dietary supplements being sold for weight loss, sexual 

enhancement, bodybuilding or pain relief that contain potentially dangerous undeclared 

drug ingredients; and, increasingly, products laced with the highly-potent opioid fentanyl. 

The risks related to illicitly-made fentanyl are just one example of how quickly new threats 

can emerge, the tough challenges we must confront and the dangers Americans face from 

these emerging risks. The SUPPORT Act provided FDA with a new tool for deterring illegal 

imports of drugs by expanding the Agency’s debarment authority to include illegal 

importation of drugs or controlled substances. Once debarred, that person is prohibited 

from being involved in any future drug importation for a period of up to 5 years and 

violation of a debarment order is a criminal offense. 

www.fda.gov

Unlabeled, unmarked pills

Foreign, unapproved Botox

Sexual enhancement product with 

undeclared drug ingredient
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While CBP handles the majority of opioid interdictions within the IMFs, the FDA also 

encounters these products. When the FDA does find illegal opioids, it means that the 

agency is the final stop from preventing them from reaching consumers. Examples of 

opioids the FDA has found include tramadol, codeine and morphine.

www.fda.gov

Foreign, unapproved anti-anxiety drug

Foreign, unapproved, controlled substance

Foreign, unapproved version of tramadol

Foreign, unapproved version of tramadol
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The FDA has seen an increase of opioids illegally entering the country and is 

strengthening collaborative efforts with USPS, CBP and DEA to detect these opioids 

coming in through the mail. The FDA is also looking for ways in which information 

related to opioid interdictions can be used to better combat the smuggling of opioids.

www.fda.gov 600,000+ pills found with no markings

Hormones found at JFK IMF

Repetitive bulk shipment from single supplier
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The FDA is on the front lines of the consumer protection mission and a robust import 

program is critical to this mission. To protect the public health from these illegal and 

potentially dangerous products, the FDA will continue to identify ways to both 

maximize and extend existing resources and authorities.

www.fda.gov

Packages for FDA review at JFK IMF