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US FDA regulation update - Phase V

As a part of The Bioterrorism Act of 2002, The U.S. Food and Drug Administration (FDA) recently announced interim final rules that require registration of domestic and foreign food facilities and prior electronic notice of food imports.

FedEx strongly encourages you to review the new rules below and take the necessary actions, as failure to comply will result in shipments being delayed or possibly refused entry into the U.S.

Phase V full enforcement of the FDA Prior Notice (PN) regulations for imported food began on November 8, 2004, as confirmed by Customs and Border Protection (CBP) operational guidelines and memo to the trade issued on November 5, 2004. Full enforcement is understood to be compliance with all provisions of the PN regulations, including timely submission of Prior Notice, i.e. not later than 4 hours prior to aircraft arrival at the first US port of arrival. Increased CBP enforcement actions to confirm PN at the first port of arrival creates the possibility that some food shipments may be delayed and even refused entry if PN is not properly submitted in accordance with the FDA regulations.

We would like to inform that FedEx can not pick up the shipments if the PN confirmation has not been obtained. You can directly visit www.access.fda.gov in order to apply for PN Confirmation.

Definition of Food in the Bioterrorism Act of 2002

• Articles used for food or drink for consumption by humans or animals
• Chewing gum
• Articles used for components of any such article

Affected Food Commodities

• All food items must be non-perishable.
• All "food" as defined by the FDA, being imported or offered for import into the United States
• Food stored or distributed in the US
• Gifts - to or from a business
• Samples to be used for quality assurance, tradeshows and testing purposes
• Transshipments through multiple US ports
• Food imported for future export
• Food admitted into a US Foreign Trade Zone (FTZ)

Excluded Food Commodities

• Personal use food accompanying a traveler
• Food immediately exported, without leaving the port of arrival
• Meat, poultry, and egg products - exclusively regulated by the US Department of Agriculture
• Homemade goods made in personal residence, sent by that individual as a personal gift, for non-business reasons
• Food contact substances (e.g. packaging material, jars, containers and pesticides) which do not qualify under FDA's definition of "food"
• Individual to individual for non-commercial/non-business purposes

For the detailed information of Facility registration and Prior Notice, please click here.

FedEx will continue to monitor the status of the new provisions and periodically update the site. We strongly encourage you to regularly visit this site to stay informed of future updates.