Prior notice is a regulatory requirement for the importation of food articles into the United States. Failure to submit timely and accurate Prior Notice for imported consumable goods can result in a refusal, hold, injunction, prosecution, and financial penalties from FDA and CBP.
If you are an individual with knowledge of the required information, you can submit Prior Notice via this web entry system.
Product Code
The us fda prior notice product code is a string of five to seven numbers and letters that describe a specific food item. This information is required for all articles destined for the U.S.
The FDA product code describes a single food item, but can also be used for a group of products (e.g., a fish known under several regional names).
The product code contains five elements: Industry Code, Class, Subclass, Process Indicator Code and the Product (Group) element. For medical devices, the Product (Group) element is two letters and when used in conjunction with the class, identifies a specific medical device.
Manufacturer
If you ship food or food products to the U.S., FDA requires you to submit Prior Notice before it is imported or offered for import (21 CFR 1.276(b)(5); 21 CFR 1.277(a)).
You can file your prior notice electronically through the FDA Prior Notice System Interface or CBP’s Automated Broker Interface/Automated Commercial System (ABI/ACS). Once you have submitted all of the information required by FDA, you will receive confirmation, including a PN Confirmation Number, from either FDA or CBP.
Grower/Consolidator
The FD&C Act requires grower information be provided if the product is commingled with food from different growers or growing locations. However, you may choose to identify the consolidator in lieu of a known grower if your knowledge of the product’s identity is less than perfect.
The Prior Notice System Interface (PNSI) makes it easy to get the most important information on the grower or consolidator of your food product. Simply select the FDA Country of Production from the dropdown box on the Prior Notice: Related Facilities (View) page and choose the Enter Grower/Consolidator button.
Shipper
Prior notice for shipments of food entering the United States by air must be confirmed by FDA at least 2 hours before the aircraft arrives at the port where it first arrives in the U.S. (21 CFR 1.279(b)).
If FDA’s review process determines that the prior notice submission is inaccurate, the food could be refused under 801(l) of the FD&C Act and 21 CFR 1.283(a)(1) when it arrives at the border. If the food has a PN Confirmation Number, CBP will receive notice that the prior notice has been received by FDA for review.
Owner
The owner of the meager prize is not necessarily the person who scribbles out the most informational entries, but rather an individual who is able to take advantage of CBP’s and FDA’s state of the art computer systems. The person in question may be the filer, the broker or the manufacturer – you get the idea. The most important part of the equation is knowing who to put in charge of your food and fad. This is where the aforementioned FDA Prior Notice system comes in. Its ilk makes sure your entries make the cut.
Ultimate Consignee
The ultimate consignee is the person or organization receiving the product for the designated end use. This helps companies identify the true end user, which makes it easier to track and manage the product and avoid confusion in customs and regulatory requirements in the destination country.
Unless an exemption applies, FDA regulations require prior notice of all shipments of articles of food to be imported into the United States for importation, sale, or export. The information required varies by entry type.
Holding Facility
Prior Notice is required for food for humans or animals that will be imported or offered for import into the U.S. for use, storage, or distribution (21 CFR 1.277(c)).
Unless an exemption applies, FDA requires prior notice of the product. This is an important requirement to avoid a potential refusal of the product and a hold at the port if the product is not in compliance with FDA Prior Notice regulations.
If CBP has directed your article to a Holding Facility after you have transmitted your Prior Notice through PNSI, you will need to provide the holding facility information. This is done on the Prior Notice: Related Facilities (View) page.