Quick Answer
Prior Notice (PN) is a mandatory FDA filing required before food articles are imported into the United States. Under 21 CFR Part 1, Subpart I, the FDA must receive advance notice of every food shipment arriving at a US port of entry. Failure to file prior notice — or filing with errors — results in the shipment being held or refused at the border.
Regulatory Authority: 21 CFR Part 1, Subpart I — Prior Notice of Imported Food (Section 801(m) of the FD&C Act)
What Is Prior Notice?
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ImmutablePrior notice is an advance notification to the FDA that a shipment of food (including animal feed, dietary supplements, and beverages) is being imported into the United States. The requirement was established by the Bioterrorism Act of 2002 and is intended to give FDA time to review incoming shipments and target inspections of high-risk imports.
Every article of food imported or offered for import must have a prior notice submission accepted by FDA before arriving at the port of entry. The PN must contain detailed information about the food, shipper, manufacturer, and anticipated arrival.
Security Screening
FDA uses PN data to screen shipments for food safety and biosecurity risks before arrival
Border Clearance
An accepted PN confirmation number is required for CBP to release food shipments
Who Must File Prior Notice?
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Prior notice can be filed by any party in the import chain, including:
- The importer or importer's agent: The US buyer, customs broker, or freight forwarder
- The foreign shipper: The entity shipping the food from abroad
- The manufacturer: The foreign facility that produced the food
In practice, customs brokers or freight forwarders typically file PN on behalf of the importer. Regardless of who files, the information must be accurate and complete.
Filing Deadlines and Timing
The minimum advance notice varies by mode of transportation:
Ocean (vessel)
No sooner than 15 days before arrival; no later than 8 hours before arrival at first US port
Air
No sooner than 15 days before arrival; no later than 4 hours before arrival at first US port
Rail
No sooner than 15 days before arrival; no later than 4 hours before the food arrives at the US border crossing
Truck (road)
No sooner than 15 days before arrival; no later than 2 hours before the food arrives at the US border crossing
International mail
No sooner than 15 days before arrival; must be received before food arrives at the US port
Timing Is Critical
Filing too early (more than 15 days before arrival) or too late (after the deadline for your transport mode) will result in rejection. Ensure your filing aligns precisely with the transport schedule. Time zones matter — deadlines are based on the local time at the port of arrival.
Required Information for PN Filing
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"Procedures for verifying supplier controls were not adequately established."
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Each prior notice submission must include:
- Submitter information: Name, address, phone, fax, and email
- Transmitter information: If different from submitter
- Entry type: Consumption, informal, mail, etc.
- FDA product code: The specific product code from FDA's Product Code Builder
- Common or market name: The name of the food as it is commonly known
- Quantity: The quantity described from the smallest package to the largest container
- Manufacturer information: Name, address, and FDA registration number of the manufacturer
- Shipper information: Name and address of the foreign shipper
- Country of production: Where the food was produced or grown
- Arrival information: Anticipated arrival date, port of arrival, and mode of transport
- Carrier and transportation details: Carrier name, bill of lading, container numbers
How to File Prior Notice
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Prior notice can be filed through two FDA systems:
FDA Prior Notice System Interface (PNSI)
The web-based PNSI at access.fda.gov allows manual entry of prior notice information. This is suitable for low-volume filers. You need an FDA Industry Systems account to access PNSI.
CBP Automated Broker Interface (ABI)
For high-volume filers, prior notice data can be transmitted electronically through CBP's ABI system as part of the customs entry process. Most customs brokers use this method.
Common Filing Errors and Rejections
Wrong FDA Product Code
Using an incorrect product code that does not match the actual food being imported
Impact: Prior notice rejected; shipment held at port until corrected
Unregistered Manufacturer
The foreign manufacturer listed in the PN is not registered with FDA or registration has lapsed
Impact: Prior notice rejected; food cannot enter until manufacturer registers
Missing or Incorrect Arrival Information
Wrong port of arrival, incorrect arrival date, or missing carrier details
Impact: Prior notice may not match customs entry; shipment delayed
Filed Too Late or Too Early
PN submitted outside the allowed time window for the transport mode
Impact: Automatic rejection; must refile with corrected timing
Prior Notice Amendments and Cancellations
If information changes after filing, you may need to amend or cancel the prior notice:
- Amendments: You can amend most PN data elements before the shipment arrives. Use the original PN confirmation number to submit changes.
- Cancellations: If a shipment is canceled or will not arrive, cancel the PN to avoid discrepancies in FDA records.
- Re-filing: If the PN was rejected, correct the errors and submit a new filing. Each new submission receives a new confirmation number.
FDA Enforcement and Penalties
FDA enforces prior notice requirements strictly:
- Article held at port: Food arriving without an accepted PN is subject to hold at the port of arrival until a proper PN is submitted and accepted
- Refusal of admission: FDA can refuse admission of food with inadequate or false prior notice information
- Re-exportation or destruction: Food that cannot be brought into compliance may be required to be re-exported or destroyed at the importer's expense
- Demurrage charges: Holds at port incur significant storage and demurrage charges that fall on the importer
How Assurentry Can Help
Assurentry provides comprehensive prior notice filing support:
- PN filing services: Accurate prior notice submissions with quick turnaround
- Product code assistance: Help selecting the correct FDA product codes
- Manufacturer registration: Ensuring all foreign manufacturers are properly registered
- Error resolution: Quick correction and re-filing when issues arise
- FSVP coordination: Integrating PN filing with your broader import compliance program
Avoid Costly Port Holds
A single prior notice error can delay your shipment for days and cost thousands in demurrage fees. Our team ensures accurate filings every time.
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