WASHINGTON, D.C. – Prior notice must be received and confirmed electronically by FDA no more than five days before arrival and, as specified by the mode of transportation below, no fewer than:

1) two hours before arrival by land or road;

2) four hours before arrival by air or rail;

3) eight hours before arrival by water.

Who must submit prior notice?

Any individual with knowledge of the required information may submit the prior notice, including, but not limited to, brokers, importers and U.S. agents.

Where must it be submitted?

Electronically, to the FDA PN System Interface at www.access.fda.gov, or via CBP’s Automated Broker Interface of the Automated Commercial System (ABI/ACS).

For help submitting notice through the FDA PN System Interface, call the Help Desk (open 7 a.m. to 11 p.m. EST) at 301-575-0156, fax 301-210-0247, or e-mail furls@fda.gov. For assistance with ABI/ACS transmission, contact your customs broker.

What food is subject to the requirement for prior notice?

Section 201 (f) of the Federal Food, Drug and Cosmetic Act defines “food” as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such articles.

Examples of “food” include: Dietary supplements and dietary ingredients; infant formula; beverages, including alcohol 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; bakery goods, snack food, and candy (including chewing gum); live food animals; animal feeds and pet food.

(A bagged lunch for your own personal consumption does not have to be reported in advance.)

Does the carrier need the prior notice confirmation upon arrival at Customs?

In a word, yes. It is prudent to have the confirmation upon arrival. For a prior notice that is submitted through the ABI/ACS interface, the prior notice confirmation number, together with a “PN received” message will be made available to the filer through the ABI/ACS interface. If prior notice is submitted through the FDA PN System Interface, then the transmitter will receive a confirmation online as soon as the submission is confirmed.

Drivers should have a copy of the confirmation upon arrival at Customs, which includes a prior notice confirmation number.

Can an incomplete prior notice be corrected?

Yes. If the submission fails validation, it will be rejected and the submitter will be notified and given the opportunity to make corrections.

THE FDA PN System has Help features to assist the submitter, and the Help desk is also available starting Dec. 12.

What are the data elements that must be submitted?

For a detailed list of data elements which must be included in the prior notice submission, visit www.cfsan.fda.gov/~dms/fsbtac13.html

What must be done if information changes after prior notice confirmation has been received?

If any of the required information listed at the address above changes after confirmation, then an entirely new prior notice must be submitted. The only exception to this is the estimated quantity of the food.

Does food that has already been refused for inadequate prior notice require any additional information in the subsequent submission?

Yes. If prior notice is refused due to inadequate information the first time around, the second submission must include additional data elements, namely: the port of arrival, the location where the refused food is being held, the date it arrived or will arrive there, and the identification of the contact person at that location. (Visit the Web address listed above for a list of data elements.)

What are the consequences of failing to submit adequate prior notice?

While the FDA plans to adopt a soft enforcement policy in the short term, food that is imported without adequate prior notice is still subject to refusal and/or holding at the port or in secure storage. The transition period for “soft” enforcement has not yet been announced by the FDA.