FDA Food Import Regulations

The Bioterrorism Act of 2002 requires several new actions for food manufacturers, importers, and carriers, including facility registration, prior notice of imported shipments, and specific recordkeeping. Increased enforcement of these new regulations may result in shipment delays, fines, or penalties. In some cases, shipments may be refused admission to 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.

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" as defined by the FDA, being imported or offered for import into the United States
  • Food stored or distributed in the US
  • Gifts sent to or from a business, regardless of personal or commercial use
  • 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

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.

More Information on:
Facility Registration
Prior Notice
Recordkeeping Regulations