The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take additional steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.

Along with other provisions, the Act requires that the US FDA Prior Notice should be given in advance on FDA imports including animal feed that is imported or offered for import into the United States. Advance notification of FDA imports allows the FDA, with the support of the U.S. Customs and Border Protection (CBP), to target import inspections more effectively and help protect that nation’s food supply against terrorist acts and other public health emergencies.

US FDA Prior Notice is required for FDA imports of human and animal food importations and food transiting through the United States unless an exemption under the FDA regulation applies.

US FDA Prior Notice of FDA imported food shipments will give FDA time to:

• Review and evaluate information before an FDA food product arrives in the U.S. as an FDA import.
• Better deploy resources to conduct inspections.
• Help intercept contaminated products shipped with FDA Prior Notice.

FDA must electronically receive and confirm US FDA Prior Notice before a food shipment arrives at the first port in the United States (port of arrival). The deadline for submitting an FDA Prior Notice depends on the mode of transportation used for FDA import shipments.  

Except in the case of food arriving by international mail, FDA must receive and confirm a Prior Notice:

1) no more than 30 days before a shipment arrives, if FDA Prior Notice is submitted via ABI/ACE: or

 2) no more than 15 days before a shipment arrives if a US FDA Prior Notice is submitted via FDA’s PNSI portal.

The following commodities are excluded from the FDA prior notice requirements of FDA import regulations:

• Personal food and/or gifts (non-commercial purpose) accompanying or shipped by an individual for FDA import.
• Merchandise that is immediately exported (IEs).
• Meat, poultry, and egg products that are exclusively under the USDA jurisdiction.
• Homemade goods shipped as gifts.
• Food items shipped via diplomatic pouch.
• Foods that are normally subject to the BTA/FDA regulations are shipped as personal effects (household goods).
• Non-consumption samples for testing only.

When a prior notice FDA web entry is filed for an FDA import, the government may decide to provide a Notice of FDA Action to the filer, importer, owner, and/or consignee when the FDA decides to examine or collect a sample. The Notice of FDA Action: Advises that the entry is to be held for an FDA examination or sampling; and specifies the items (lines) in the entry that need to be held.  

FDA Prior Notice web entry data must be electronically submitted, and confirmation issued by the FDA for FDA imports before the clock starts.  The pre-filing times are dependent upon the mode of transportation for the goods. The minimum time limits are:

• Truck/Pedestrian/Cart/Car: 2 hours before arrival
• Air/Rail: 4 hours before arrival
• OceanVessel: 8 hours before arrival

When CBP detects this sort of violation in a prior notice FDA import shipment, the consequences for smuggling can be substantial.  CBP has existing and sufficient enforcement authority in this type of matter.  All food merchandise submitted under the FDA PN may be seized and can be subjected to forfeiture.  The violators may face significant penalties or liquidated damage claims. In certain cases, the violators may be criminally prosecuted. Upon conviction, the FDA may disbar someone from ever importing food items into the United States.  CBP may also apply significant civil monetary penalties to anyone who knew, assisted, or aided in the unlawful importation of these violative goods.

FDA recommends that a Prior Notice of FDA confirmation accompanies any shipment of imported food.

If an FDA Import Shipment Arrives…