Printable Version Food Export (FDA) Regulations


Prior Notice 
Click here  to file the Prior Notice directly with the FDA using the FDA Prior Notice System Interface (PNSI).
As a part of the Bioterrorism Act of 2002, the U.S. Food and Drug (FDA) Administration announced interim final rules that require registration of food facilities and prior electronic notice of food exports into the U.S. Although these new requirements were implemented on December 12, 2003, the FDA did not begin full enforcement of Prior Notice (PN) until November 8, 2004.  For more information on the FDA Compliance Policy, please visit the FDA Web site.

To avoid delays and penalties, you must provide a PN web entry summary confirmation or FedEx Express Prior Notice Form when tendering food shipments to FedEx.

If you are exporting food articles into the U.S., ensure that you have registered with the FDA as required, and are able to provide the required Prior Notice data for each shipment. Affected food articles arriving in the U.S. without this information are subject to service delay and possible refusal by the FDA.

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 FDA, "being exported or offered for export into the United States"
  • Food stored or distributed in the U.S.
  • Gifts to and from a business
  • Samples to be used for quality assurance, tradeshows and testing purposes (for human or animal consumption)
  • Transshipments through 2 U.S. ports to another country
  • Food exported into the U.S. for future export
  • Food admitted into a U.S. Foreign Trade Zone (FTZ)

Food Commodities Excluded

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

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



Facility Registration

Foreign Food Facilities



  • Foreign food facilities that manufacture, process, pack or hold food are required to have a U.S. agent to register with FDA. It can be any person that resides or maintains a place of business in the U.S. and is physically present in the U.S. The designated U.S. agent acts as a communications liaison between FDA and the facility for both routine and emergency communications.
  • If a Foreign food facility that manufactures, processes, packs or holds food sends it to another foreign food facility for further manufacturing, processing or packaging before the food is exported to the U.S., only the last foreign facility is required to register, except if the subsequent facility is conducting de minimis activities such as labeling. In such cases, both facilities must register.
  • FedEx Trade Networks can help you with the registration for a fee. Please visit FedEx Trade Networks FDA site at fda.ftn.fedex.com or call 1.800.249.2953 for more information on the service.


Exemption



  • The following entities are exempted from the registration requirement:
    • Private residences of individuals
    • Non-bottled water and drinking water collection & distribution establishments
    • Transport vehicles that hold food only in the usual course of their business as carriers
    • Farms
    • Restaurants
    • Retail food establishments
    • Non-profit food establishments
    • Fishing vessels
    • Facilities regulated exclusively by USDA


Registration Method



  • Electronic registration is encouraged and will be available worldwide, 24 hours a day, 7 days a week. To access FDA's online form click here.
  • Paper registration is also accepted if Internet access is not readily available. Please note that it's a much slower process, and you need to ensure that form is complete and legible.
  • FedEx Trade Networks can help register your foreign facilities for a fee. For more information on the service, please visit FedEx Trade Networks FDA site at fda.ftn.fedex.com or call 1.800.249.2953.
  • The following instructions and forms are available for download from the FDA Web site. The completed PDF form may be printed and mailed to the U.S. Food and Drug Administration, HFS-681, 5600 Fishers Lane, Rockville, MD 20857, or faxed to 301.210.0247.


Download forms and instructions:





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.



Prior Notice



  • Prior Notice must be submitted to FDA prior to the submission timeframes listed below.
  • Any individual with knowledge of the required information, including but not limited to brokers, importers, exporters and U.S. agents, may submit Prior Notice.
  • If you are exporting food articles into the U.S., ensure that you have registered with the FDA as required, and are able to provide the required Prior Notice data for each shipment. Affected food articles arriving in the U.S. without this information are subject to service delays and possible refusal by the FDA.
  • Shippers are encouraged to submit Prior Notice (PN) directly to the FDA to minimize delays for all food shipments entering or transiting the U.S. FedEx Express will submit PN on behalf of our customers; however, the shipper must provide all PN data elements as part of the shipment documentation. Food shipments may be delayed while PN is submitted and confirmed.


For more information on the FDA Compliance Policy, please visit the FDA Web site.

Required Submission Timeframe



  • The specific timeframe for Prior Notice submission is determined by mode of transportation:
    • 2 hours before arrival by land by road
    • 4 hours before arrival by air or by land by rail
    • 8 hours before arrival by water


Information Change after Submission



  • A new Prior Notice must be submitted if changes are made after Prior Notice confirmation has been received. When changes are submitted, the clock for Prior Notice submission will be reset.
Prior Notice System Interface (PNSI)

  • FedEx strongly encourages you to file Prior Notice directly with the FDA to help minimize delays.  Prior Notice can be filed directly with the FDA using the Prior Notice System Interface, which is available on the FDA Web site.
  • To accommodate those transmitters shipping via Express courier, where the transmitter does not have access to the required anticipated arrival information and/or planned shipment information, the transmitter should use 'consumption express courier' as the entry type.  This entry type is to be used only by shippers sending articles of food to the U.S. via express couriers.  For more information, please visit the FDA Web site.


Download Forms and Instructions


  • FDA Prior Notice System Interface (PNSI)
    Include three copies of the PN web entry summary confirmation and Commercial Invoice with your shipment.  The PN web entry summary confirmation number, on its own, is not sufficient.  In addition, the PN web entry summary confirmation number must be written in the description field on your FedEx International Air Waybill.




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