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New U.S. Food Import Rules

Noncompliance may cause fines, shipment delays or refused entry into the U.S.

The U.S. Food and Drug Administration (FDA) has announced new provisions for shipments of food imported to the U.S. The new provisions, under the Bioterrorism Act of 2002 are intended to protect the safety and integrity of the U.S. food supply. The new rules, to be effective December 12th, 2003, require for Registration of domestic and Non-US food facilities and Prior Notice of all food shipments entering the U.S.

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 imported or offered for import into the United States"
  • Food stored or distributed in the U.S.
  • Gifts, trade, and quality assurance/control samples
  • Transshipments through the U.S. to another country
  • Food imported for future export
  • Food admitted into a U.S. Foreign Trade Zone (FTZ)
Food Commodities Excluded
  • Personal use food accompanying a traveler
  • Food immediately exported, without leaving the port of arrival
  • Meat, poultry, and egg products - exclusively regulated by the U.S. Department of Agriculture
  • Homemade goods sent as a gift to an individual
  • 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 with future updates.


Facility Registration

The new rules require facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with FDA by December 12th, 2003.

The following type of facilities are, however, exempted from the registration requirement:
  1. Private residences of individuals
  2. Non-bottled water and drinking water collection & distribution establishments
  3. Transport vehicles that hold food only in the usual course of their business as carriers
  4. Farms
  5. Restaurants
  6. Retail food establishments
  7. Non-profit food establishments
  8. Fishing vessels
  9. Facilities regulated exclusively by USDA

Non-US facilities need to appoint an agent that is located in the U.S. before they can register. The agent acts as a communications link between FDA and the facility for both routine and emergency communications and can be any individual or company located in the U.S. The registration requirement applies to each covered facility, not to firms or companies as a whole. E.g. a company with 10 facilities must register each one separately.

Registration is one time, not annual. However, changes to facility registration data must be updated with the FDA within 60 days.

If a facility that manufactures, processes, packs or holds food sends it to another 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.

Food shipments from non-registered facilities are subject to service delays and may be held at the port of arrival until registration requirements are met.

Methods of Registration

  • Electronic registration is available worldwide, 24 hours a day, 7 days a week. To access FDA's online form please visit:
    http://www.cfsan.fda.gov/~furls/ovffreg.html
    Non-US facilities need to appoint an agent that is located in the U.S. before they can register.

  • 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. Instructions and forms are available for download from the FDA website:
    http://www.cfsan.fda.gov/~furls/papercd.html


Prior Notice

FDA also requires advance notice of all shipments of human and animal food being imported or offered for import into the U.S.

Food shipments that require Prior Notice
  • Dietary supplements and dietary ingredients
  • Infant formula
  • Beverages (including alcoholic beverages and bottled water)
  • Fruits and vegetables
  • Fish and seafood
  • Dairy products and shell eggs
  • Raw agricultural commodities for use as food or components of food
  • Canned and frozen foods
  • Live food animals
  • Bakery goods, snack food, candy, and chewing gum
  • Animal feeds and pet food

Prior Notice can be submitted by the shipper, importer, carrier or an agent using FDA's new web-based Prior Notice System, or can be submitted as part of the U.S. Customs Broker's entry declaration.

Shipments lacking Prior Notice to FDA are subject to service delays or possibly refused entry into the U.S. We therefore urge you to review these regulations closely.

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.


FedEx can help you meet these new requirements

Registration

We can register your non-U.S. based facilities and also simplify things by serving as your U.S.-based agent for food shipments to the U.S., at a yearly fee.

For a price quote, please fill out the request form.

You can also call the U.S. number +1 716 879 1075.

Prior notice Procedure

For all your food packages shipped to the U.S. with FedEx, we can provide prior notification to the FDA on your behalf using information you will provide us. This is recommended to avoid any service delays and is free of charge.

Please download the Prior Notice Form (PDF), fill it out and give it to our courier with your U.S. destined food shipments.

Detailed information is available from the FDA Bioterrorism website as follows:
http://www.fda.gov/oc/bioterrorism/bioact.html

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