FDA Prior Notice
Required for every food shipment entering the United States. We submit your Prior Notice electronically through the FDA's Prior Notice System Interface (PNSI) before each shipment, so your cargo is cleared without delay.
What the PN must include
- ✓ Product name and FDA food category
- ✓ Manufacturer name and FDA registration number
- ✓ Shipper details and country of origin
- ✓ Anticipated US port of entry and arrival date/time
- ✓ Carrier information (vessel, flight, truck, or rail)
- ✓ Lot or code numbers (where applicable)
- ✓ Submitter information and confirmation number
When Prior Notice Must Be Filed
Deadlines vary by mode of transport. Missing the window means the shipment is refused at the US border.
Ocean freight
At least 8 hours before arrival at the US port
Air freight
At least 4 hours before arrival at the US airport
Rail
At least 4 hours before arrival at the US rail crossing
Road / truck
At least 2 hours before arrival at the US border crossing
All modes
No more than 30 days before the shipment arrives
How It Works
Send shipment details
Share your product, shipper, carrier, port, and expected arrival details before each shipment. We need this information at least 24 hours before the submission deadline to process on time.
We submit through FDA's PN system
We file the Prior Notice electronically through the FDA's Prior Notice System Interface (PNSI), which links to US Customs and Border Protection. You receive the confirmation number for your records.
Shipment clears with valid PN on file
Your shipment arrives at the US port with a valid Prior Notice confirmation number already on file. CBP and FDA use this to verify registration and release the shipment for entry.
Common questions
What is FDA Prior Notice?+
Prior Notice is a mandatory pre-arrival notification that must be submitted to the FDA before any food shipment enters the United States. It is required under Section 307 of the Bioterrorism Act of 2002 for all food imported or offered for import into the US, whether by sea, air, rail, or road.
Who must submit Prior Notice?+
The submitter can be the foreign exporter, the US importer, a customs broker, or any party with knowledge of the shipment. In practice, most foreign manufacturers arrange submission through their logistics agent or a service provider like FDABridge so the PN is filed correctly before every shipment.
What happens if Prior Notice is not submitted?+
A food shipment without a valid Prior Notice on file will be refused entry into the United States. CBP will not release the shipment. It must be held, re-exported, or destroyed. There is no grace period for missing Prior Notice — it must be on file before the shipment arrives.
Does Prior Notice replace FDA food facility registration?+
No. Prior Notice and food facility registration are separate requirements. Your facility must be registered with the FDA before the Prior Notice can reference a valid registration number. Both requirements must be met for a shipment to clear US customs.
Can I submit Prior Notice myself?+
Yes. The FDA's Prior Notice System Interface (PNSI) is publicly accessible. However, errors in the submission — wrong product category, mismatched registration number, or incorrect arrival timing — can cause the shipment to be flagged or refused. Most exporters use a service provider to avoid mistakes.
Do I need Prior Notice for every shipment?+
Yes. Prior Notice must be submitted separately for every individual food shipment entering the United States. It is not a one-time filing. Exporters shipping regularly to the US will need Prior Notice for each container or consignment.
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Need facility registration and Prior Notice together?
Prior Notice requires a valid FDA facility registration number. If you are not yet registered, see our Food Facility Registration service — we handle both in a single onboarding.