U.S. Food Import Rules

Noncompliance may cause fines, shipment delays or refused entry into the U.S.
As part of the Bioterrorism Act of 2002, the U.S. Food and Drug Administration (FDA) announced interim final rules that require registration of food facilities and prior electronic notice of food shipments into the United States.

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
Items shipped from one private individual to another (providing that both shipper and consignee addresses are home addresses)
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.

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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.
The following type of facilities are, however, exempted from the registration requirement:

a. Private residences of individuals
b. Non-bottled water and drinking water collection & distribution establishments
c. Transport vehicles that hold food only in the usual course of their business as carriers
d. Farms
e. Restaurants
f. Retail food establishments
g. Non-profit food establishments
h. Fishing vessels
i. 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:
Electronic Registration
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:
Paper Registration

FedEx can help you register
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.

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

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.

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 Procedure
For all your food packages shipped with FedEx to the U.S. or in transit in the U.S., we recommend that you submit Prior Notification on the FDA website http://www.access.fda.gov/.
After completion, you should automatically receive a confirmation from the FDA in PDF format via email.

Please do not schedule a pick up or tender the shipment to FedEx until you have received this document and include a printed copy with your Air Waybill and Commercial Invoice.
You should also write your Prior Notification confirmation number and indicate “Food” in the commodity description field on your Air Waybill.

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

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