FDA food product importers will be required to provide Prior Notice based on the mode of transportation.
|Mode of Transportation||FDA Guidelines||FedEx Trade Networks Processing|
|Road transport||2 hrs. before arrival||4 hrs. before arrival|
|Aircraft or railcar||4 hrs. before arrival||8 business hrs. before arrival|
|Ocean vessels||8 hrs. before arrival||6 days before arrival|
Guidelines for submitting customs paperwork include requirements by the FDA and additional time to allow for appropriate processing by FedEx Trade Networks.
- For road, you should fax customs paperwork and fax cover sheets to FedEx Trade Networks centralized FDA processing center at least 4 hours prior to arrival.
- For ocean, aircraft, or railcar arrivals, provide the additional Prior Notice information with your standard shipment documents.
In order to meet the FDA's Prior Notice guidelines, please add the following data elements to your customs paperwork:
- Identity of article of food, with estimated quantity described from the largest container to the smallest package size.
- Lot, code numbers, or other identifiers of the food (if applicable).
- Manufacturer/exporter for each article of food, including name, address, and the FDA registration number.
For the complete list of required Prior Notice data elements, please visit fda.gov.
Frequently Asked Questions
When must Prior Notice be submitted?
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.
Who can submit Prior Notice?
Any individual with knowledge of the required information, including but not limited to brokers, importers and U.S. agents, may submit Prior Notice.
What happens if my Prior Notice information changes 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.
What information is required in the Prior Notice?
The following information is required for Prior Notice:
- Submitter details (name of individual, individual's phone number, name and address of submitting firm).
- Transmitter, if different than submitter.
- Entry type.
- CBP entry identifier.
- The identity of the article of food as follows: The complete FDA product code; common or usual name or market name; estimated quantity described from the largest container to the smallest package size; and the lot or code numbers or other identifier of the food.
- Manufacturer (for food no longer in its natural state). This includes the name, address and registration number.
- Grower, if known.
- FDA country of production.
- Shipper (including name, address and registration number).
- The country from which the article is shipped.
- Anticipated arrival information (port of arrival and crossing location within that port, date and time).
- Name and address of the importer, owner, and ultimate consignee.
- Mode of transportation.
- Carrier's Standard Carrier Abbreviation Code (SCAC) or International Air Transport Association Code (IATA).
- Planned shipment information including the 6-digit Harmonized Tariff System (HTS) code.
Will my in-bond shipments be affected by the Prior Notice regulation?
Yes, in-bond shipments will require Prior Notice. Some of the data elements, such as registration numbers, are not required for bonded shipments.
Are my low-value shipments exempt from the new FDA regulations?
No. Low-value food products are not exempt. Under the new FDA regulations, shipments that may have been subject to Section 321 (consolidated informal entries for gift and sample exemptions) are now required to file entries and Prior Notice.