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. The Notice of FDA Action will state the reason(s) why the product(s) have been refused. The FDA will issue a Notice of FDA Action indicating the product(s) have been refused. 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. 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. 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. What happens after the intended recipient responds to the initial Notice of FDA Action? 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. 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. What happens to international mail that appears to violate the FDA's laws and regulations? Packages examined by the FDA have consisted of single or multiple products, some lacking labeling in English. 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. What types of packages are referred to the FDA at an IMF? 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. 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.
What role does the FDA play at an IMF?Īt 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. Virgin Islands respectively and two locations in California. There are currently nine IMF locations across the U.S., with one location in Florida, Hawaii, Illinois, New Jersey, New York, Puerto Rico, U.S. The FDA generally refers to the international mail facilities as IMFs. CBP then refers FDA-regulated products to the FDA's investigators for review. Customs and Border Protection (CBP) for examination. Upon initial screening at arrival, USPS sends packages to U.S.
Postal Service (USPS) sorting facility (International Mail Facility). What is an International Mail Facility (IMF)? What happens after the intended recipient responds to the initial Notice of FDA Action?.
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