FDA Prior Notice

U.S. FDA Food Imports Prior Notice Form
Complete Shipment Information
New U.S. Food and Drug Administration (FDA) regulations, issued under the "Bioterrorism Act", require food shippers to provide additional information to clear U.S. Customs and Border Protection. In order to avoid delays in shipment clearance and delivery, you and your suppliers and affiliates outside the United States will need to take important steps to comply.

1. U.S. domestic and foreign facilities that manufacture and process, pack, or hold food for human or animal consumption in the United States must register with the FDA, unless the facility qualifies for an exemption under the FDA regulations.

2. Foreign food facilities covered by these regulations must designate a U.S. agent.

3. Prior notice is required for human and animal food imported into and transiting through the United States, unless an exemption under the FDA regulation applies.

Note: Prior Notice is not required for home-made non-commercial food shipments shipped by an individual, to an individual, as gifts for personal use. Furthermore, current FDA policy is not to require Prior Notice when food purchased at a commercial establishment is exported or offered for export by a non-commercial shipper for a non-commercial purpose (i.e., from an individual, to an individual, as a gift or as a household good for personal use). Additional exclusion criteria can be found at the FDA web site.

To register or obtain additional information, select the link below:
US FDA Industry Systems

Unless you already have a Prior Notice Confirmation (PNC) number for the shipment, UPS will request it on your behalf. In order for UPS to submit the PNC request to the FDA, information regarding the food item being shipped is required. Once all fields have been completed, you will need to print the form and include it with the package. Please note that, even if you provide all the Prior Notice information specified below, U.S. Customs and Border Protection may still determine that additional information and/or inspection (which may result in delays) is needed to comply with the FDA regulations.

Complete a separate form for each food item being shipped to the U.S.

Please provide all requested information in English; U.S. Customs and Border Protection can only process Prior Notice information submitted in English.

Required fields are shown in bold

Lead Shipment UPS Tracking number:

Estimated Export Date:
   

Prior Notice Confirmation (PNC) Number:
(Given the FDA's information requirements for obtaining a PNC, it is recommended that UPS submit the PNC request on your behalf.)

Food Item Description (Detailed):

Harmonised Tariff Schedule (HTS) code:

FDA Product Code:


Please note: If you are supplying a PNC Number for this food item you do not need to complete the remaining fields.

Shipper Facility Registration Number:


Manufacturer Facility Registration Exemption Reason (If Exempt, skip Manufacturer Facility Registration Number field below):
Non-Exempt Facility.
Facility is out of business.
Facility is private residence.
Facility is a restaurant.
Facility is retail food establishment.
Facility is non-processing fishing vessel.
Facility is non-bottled drinking water collection and distribution establishment.
Individual gift.
Grower-Satisfies farm exemption
Samples - quality assurance, research or analysis purposes only
U.S. manufacturing facility that is not required to register.
Unable to determine the registration number of the manufacturer.
Unable to determine identity of manufacturer - providing identity of manufacturers headquarters.
Unable to determine identity of maufacturer or headquaturers - providing invoicing firms identity.
Gift pack for non-business purposes providing single prior notice and identity of packer.

Manufacturer Facility Registration Number:

Manufacturer Name:

Manufacturer Street Address:



Manufacturer City:

Manufacturer State/Province (US/CA):

Manufacturer Country or Territory:

Manufacturer Post Code: (Required for countries or territories with an *)

Producer Firm Type:

Quantity:

Unit of Measurement:

Weight:

Unit of Measurement:


Please note: If you are supplying an FDA Product Code, you do not need to complete the three following fields.

What material is touching the actual items (i.e. Plastic)?

Enter the smallest item's weight or volume (i.e. 1 kg):

Break down the quantity of the packing (i.e. 12 cases, 24 cans a case, 12 ounces a can):