- What is an International Mail Facility (IMF)?
- Where are IMFs located?
- What role does the FDA play at an IMF?
- What types of packages are referred to the FDA at an IMF?
- What happens to international mail that appears to violate the FDA's laws and regulations?
- What happens after the intended recipient responds to the initial Notice of FDA Action?
Mail entering the U.S. from abroad arrives at a U.S. Postal Service (USPS) sorting facility (International Mail Facility). Upon initial screening at arrival, USPS sends packages to U.S. Customs and Border Protection (CBP) for examination. CBP then refers FDA-regulated products to the FDA's investigators for review. The FDA generally refers to the international mail facilities as IMFs.
There are currently eight IMF locations across the U.S., with one location in Florida, Hawaii, Illinois, New Jersey, New York, California Puerto Rico, and the U.S. Virgin Islands respectively.
At the IMFs, the FDA provides front line defense against illegal, illicit, unapproved, counterfeit and potentially dangerous drugs and other violative FDA-regulated products from entering the U.S. via international mail. The FDA's investigators are responsible for monitoring mail importations of FDA-regulated products by conducting comprehensive examinations of packages that have been referred by CBP. The FDA examines and determines admissibility of packages containing FDA-regulated products that are imported through the IMF. If a package is found or suspected to contain a controlled substance during the FDA's screening, it is referred to CBP for an admissibility determination.
Packages referred to the FDA by CBP contain a wide range of FDA-regulated products such as dietary supplements, medical devices, and human drugs. These packages include unapproved products; counterfeit or substandard drugs; dietary supplements being sold for weight loss, sexual enhancement, bodybuilding or pain relief that contain potentially dangerous undeclared ingredients. Packages examined by the FDA have consisted of single or multiple products, some lacking labeling in English.
If an inspected mail package contains product(s) that appear to violate the FDA's laws and regulations and the products do not meet the definition of a personal importation, the package may be detained. The FDA notifies the responsible party by issuing a Notice of FDA Action that will either state “Detained” or “Detained/May be Destroyed.” For more information on the Detention and Hearing process visit the Detention & Hearing web page.
Once the imported product(s) have been detained by the FDA at an IMF, the next step will depend on whether or not sufficient evidence was provided to the FDA to overcome the appearance of the violation.
If the testimony submitted allows the FDA to determine the product(s) are in compliance with the FDA's laws and regulations, the package will be forwarded to the recipient and the FDA will issue a Notice of FDA Action indicating the product(s) have been released.
If the testimony supplied to the FDA is not sufficient to determine that the product(s) are in compliance with the FDA's laws and regulations, the product(s) will be refused admission. The FDA will issue a Notice of FDA Action indicating the product(s) have been refused. The Notice of FDA Action will state the reason(s) why the product(s) have been refused. Some refused drug products may be subject to administrative destruction; the Notice of FDA Action will indicate whether the drug will be destroyed or returned to sender. All other FDA-regulated products will be referred to USPS and returned to sender. At this point, no further action will be required by the recipient.