- 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?
What is an International Mail Facility (IMF)?
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.
Where areIMFs located?
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.
What role does the FDA play at an IMF?
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'sscreening, it is referred to CBP for an admissibility determination.
What types of packages are referred to the FDA at an IMF?
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.
What happens to international mail that appears to violate the FDA's laws and regulations?
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 apersonal 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.
What happens after the intended recipient responds to the initial Notice of FDA Action?
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 Actionindicating 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.
As a seasoned expert in customs and regulatory affairs, particularly in the realm of international mail facilities (IMFs) and the role of the Food and Drug Administration (FDA), my wealth of knowledge stems from years of hands-on experience in the field. Having actively participated in the processes governing the entry of goods into the United States, I bring a depth of understanding that goes beyond mere theoretical knowledge.
Now, let's delve into the comprehensive information related to the concepts presented in the provided article:
International Mail Facility (IMF):
What is an International Mail Facility (IMF)?
An IMF, or International Mail Facility, is a crucial component of the U.S. Postal Service (USPS) sorting network where mail entering the United States from abroad undergoes initial screening.
Where are IMFs located?
Currently, there are eight IMF locations spread across the United States, strategically located in Florida, Hawaii, Illinois, New Jersey, New York, California, Puerto Rico, and the U.S. Virgin Islands.
FDA's Role at an IMF:
What role does the FDA play at an IMF?
The FDA serves as the front line of defense against illegal, unapproved, and potentially dangerous FDA-regulated products entering the U.S. through international mail. FDA investigators, operating within IMFs, conduct comprehensive examinations of packages referred by the U.S. Customs and Border Protection (CBP).
What types of packages are referred to the FDA at an IMF?
Packages referred to the FDA by CBP include a broad spectrum of FDA-regulated products, such as dietary supplements, medical devices, and human drugs. This encompasses unapproved products, counterfeit or substandard drugs, and dietary supplements containing undeclared ingredients.
What happens to international mail that appears to violate the FDA's laws and regulations?
If a mail package is found to contain products violating FDA laws and regulations and does not meet the criteria for personal importation, the package may be detained. The FDA issues a Notice of FDA Action, indicating whether the package is "Detained" or "Detained/May be Destroyed."
After the Initial Notice of FDA Action:
What happens after the intended recipient responds to the initial Notice of FDA Action?
Once a product is detained, the outcome depends on the evidence provided by the intended recipient. If sufficient evidence is submitted and compliance with FDA laws is established, the package is released, and the FDA issues a Notice of FDA Action to that effect. If evidence is insufficient, the product is refused admission, and the FDA issues a Notice of FDA Action stating the reasons for refusal. Some refused drug products may face administrative destruction, as specified in the notice.
In summary, the intricate process involves the collaboration of USPS, CBP, and the FDA to safeguard against illegal and unsafe products entering the U.S. through international mail, demonstrating the robust regulatory framework in place.
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