What Products Are Required To Give Prior Notice?

Prior notice of every shipment into the United States of imported food for human or animal consumption is required. There are several exemptions:

• Food contact substances;
• Pesticides; and
• Meat, poultry, and egg products subject to exclusive jurisdiction of USDA.

Is There A Fee?

No

Who May Submit the Prior Notice?

Any person with knowledge of the required information.

When Is The Deadline For Submitting Prior Notice?

The deadline for submitting prior notice is based on mode of transportation, but cannot be submitted more than 5 days before anticipated arrival:

• Arrival by road: no less than 2 hours before arrival;

• Arrival by air or rail: no less than 4 hours before arrival;

• Arrival by water: no less than 8 hours before arrival; and

• Arrival by international mail: Before sending to the United States (there is an exception provided from the five day maximum).

What Information Must Be Included In The Prior Notice?

• Name, address, phone, fax and email of the submitter and submitting firm;· Customs entry type and identifier;

• Harmonized Tariff Schedule code;

• Product identity (FDA product code (https://www.accessdata.fda.gov/SCRIPTS/ORA/PCB/PCB.HTM), common or usual name, and estimated quantity – lot numbers are not required for bottled water);

• Manufacturer’s name, address, and FDA registration number (not required of food in its natural state);

• Country of production;· Country from which the food is shipped;

• Shipper’s name, address and registration number and FDA registration number;

• Anticipated port of arrival and border crossing, date, and time of arrival;

• Name and address of importer, owner and ultimate consignee;

• Mode of transportation;

• Standard Carrier Abbreviation Code or International Transportation Code of carrier;

• Planned shipment information (bill of lading number(s); trip numbers for truck, rail, or bus).

How Do I Submit Prior Notice?

Prior notices must be submitted electronically through Customs’ existing Automated Commercial System (ACS) or FDA’s Prior Notice (PN) Interface System at www.access.fda.gov and must be in English. These systems will be available 24 hours a day/7 days a week beginning December 12, 2003. Technical assistance will be available from FDA at 1-800-216-7331 or 301-575-0156 beginning December 12, 2003.

The systems will provide the submitter with a reply message that contains a Prior Notice (PN) Confirmation Number. This number must accompany any article of food when it arrives and must be given to Customs or FDA upon arrival.

What Happens If The Information Changes?

The prior notice must be cancelled and resubmitted if the prior notice information changes except for changes to product quantity, anticipated arrival information (port, border crossing, date, and time), or planned shipment information.

What Happens If Prior Notice Is Inadequate, Inaccurate, Or Untimely?

Failure to register is a violation of Food, Drug and Cosmetic Act and a classified as prohibited act that is subject to civil and criminal penalties. Food for which the prior notice is inadequate, inaccurate, or untimely is subject to refusal of admission and holding at port. Refused food will not be delivered to the importer, owner or consignee and may be moved under custodial bond. FDA nor Customs is liable for costs incurred.

Food from a foreign manufacturer that is not registered is also subject to refused entry and same restrictions as above. In order to release the hold, the facility must register and advise FDA of the registration number.