Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, import shipments of certain foods require advanced notice so FDA and Customs and Border Protection can target inspections more effectively.
To create a Prior Notice, choose the Create Prior Notice button from the Welcome to the Prior Notice System Interface page. When saving, this changes the draft to saved status – however it does NOT submit your prior notice fda.
What is a Prior Notice?
Prior Notice is an information package regarding your food shipment that must be submitted to the United States Food and Drug Administration before its arrival into the country. This requirement goes above and beyond what’s outlined under Section 801 of the FD&C Act.
Prior Notices can be submitted by anyone involved with a shipment – shippers, exporters, brokers, importers – including shippers, exporters, brokers and importers. When using PNSI for submission of Prior Notices, carriers will require proof of submission at port arrival with copies of confirmation numbers to claim their cargo.
Food imported or offered for import into the US without prior notification will likely be rejected and returned or destroyed, violators facing fines and possible bans from future importing. It is therefore crucial that importers understand how to submit an effective Prior Notice; PriorNotify makes this easier!
What are the Requirements for a Prior Notice?
Prior notice regulations issued by the FDA can lead to costly penalties and delays in shipping, making it important that businesses understand these requirements. Failing to file an initial notice may lead to refusal of entry at U.S. borders as well as product seizures.
Before you can submit a prior notice to the FDA, you must hold either an FDA import permit or be designated an “authorized submitter”. An “authorized submitter” acts on behalf of an importer or broker to transmit information directly to them for submission to FDA.
FDA requires prior notices filed through ACS or ABI no later than 30 days before arrival at U.S. ports of arrival; 15 days for notices filed via PNSI. If your estimated shipment quantities or planned details change significantly between submissions, cancel and submit new prior notices immediately.
How do I Submit a Prior Notice?
Importing food into the United States? Proper prior notice filing is crucial to avoid delays and fees that can add up quickly. You will require all relevant details about your shipment in order to file this notice, should any exist; for assistance contact Registrar Corp’s regulatory specialist directly.
FDA suggests submitting your Prior Notice at least 30 calendar days before the expected arrival of shipments arriving through ACE/ITDS or PNSI. If any information changes after having already been confirmed by FDA, cancel and submit a new confirmation with correct information.
This guidance document serves to restate FDA’s current requirements in 21 CFR 1.276 through 1.285 regarding prior notice filing with respect to imported food, but does not confer or create rights on anyone or bind the federal agency (FDA or CBP).
What happens if the Prior Notice System is not operating?
If you’re importing food into or transshipping through the US, or transshipping between countries, it is crucial that a prior notice submission be filed with the FDA. This information helps ensure your products are suitable for American markets; failure to do so could result in lengthy delays, costly fees and possible refusal of entry into this country.
Submitting a prior notice through FDA’s Patient Notification Submission Interface or Automated Commercial Environment system only starts once FDA has reviewed and accepted your submission for review.
Submitting a prior notice may seem complicated and time consuming, but it doesn’t need to be. With affordable and convenient tools such as PriorNotify available today, making the process much more streamlined for import businesses and making import operations run more smoothly. Our video guide can show you exactly how this tool can help get the job done in minutes!