If you’re exporting food, beverages, or animal feed to the United States, you’ve likely encountered the term Prior Notice. Missing this requirement, or getting it wrong, can stop your shipment at the border, leading to costly delays and product destruction. Here is what you need to know to keep your cargo moving.
What Is Prior Notice?
Prior Notice is a mandatory electronic notification sent to the U.S. Food and Drug Administration (FDA) letting them know a food shipment is on its way. Established under the Bioterrorism Act of 2002, it applies to virtually all human and animal food products entering the United States, regardless of the country of origin, shipment size, or commercial value.
The requirement gives FDA inspectors advance warning of incoming goods so they can identify and intercept potentially unsafe or contaminated food before it ever reaches U.S. ports.
Who Does It Apply To?
Prior Notice is required for imports of:
- Human food and beverages (including alcoholic beverages and bottled water)
- Dietary supplements and vitamins
- Infant formula
- Animal food, pet food, and livestock feed
International Shipping Note: This applies whether you are shipping a full ocean container or a tiny commercial sample via courier (like DHL, FedEx, or UPS). There is no minimum quantity or value threshold for Prior Notice.
When Must You Submit? (Deadlines by Mode of Transport)
The notification must be submitted and accepted by the FDA before the shipment physically arrives at the U.S. border. Deadlines depend on how your cargo is traveling and are calculated based on the local time zone of the U.S. port of arrival:
| Mode of Transport | Minimum Submission Deadline Before Arrival |
|---|---|
| Ocean / Vessel | 8 hours |
| Air | 4 hours |
| Rail | 4 hours |
| Truck / Road | 2 hours |
| International Mail | Before mailing (the confirmation bar code must be affixed to the outside of the package) |
Submitting late, or omitting the notice entirely, gives the FDA automatic grounds to refuse entry to your shipment.
What Information Is Required?
A Prior Notice submission is highly detailed. To avoid automated rejections, you must provide:
- Manufacturer’s FDA Food Facility Registration Number (This is mandatory; the facility must be actively registered with the FDA)
- Full product description and specific FDA product code
- Quantity, packaging type, and lot/code numbers (if applicable)
- Country of origin and the country from which the article is shipped
- Shipper, Importer, Owner, and Ultimate Consignee (the receiver) names and addresses
- Anticipated U.S. port of arrival, date, and time
- Carrier details (e.g., airline/flight number, trucking company, or vessel name)
How Do You Submit?
Prior Notice is submitted electronically through one of two channels:
- FDA’s Prior Notice System Interface (PNSI): A free web portal ideal for low-volume shippers, international mail, or courier shipments.
- U.S. Customs’ ACE System: Usually utilized by licensed U.S. customs brokers who file the Prior Notice simultaneously with standard customs entry documents.
What Happens If You Don’t Comply?
The FDA and U.S. Customs and Border Protection (CBP) enforce this strictly. A shipment that arrives without an accepted Prior Notice:
- Will be refused entry into the United States.
- Will be held at the port or a secure warehouse at the exporter’s or importer’s expense.
- Cannot be delivered, consumed, or distributed while under review.
If a shipment is refused, you cannot simply file a late Prior Notice to fix it; the product must typically be exported or destroyed, and repeated violations will place your company on a high-scrutiny watch list.
Navigating FDA Registration and Prior Notice Compliance
For international exporters, successful entry into the U.S. market requires managing two distinct steps:
- Appointing a U.S. Agent for Registration: If you manufacture or process food, U.S. law requires your facility to register with the FDA and appoint a domestic U.S. Agent to act as your regulatory point of contact.
- Filing Prior Notice: Once registered, your compliance partner or customs broker can use your registration data to seamlessly file accurate Prior Notices for every outbound shipment. We can handle this for you.
Partnering with an experienced regulatory expert ensures your products are correctly classified, your facility registration remains valid, and your shipping documentation is flawless before your cargo departs.
Need Assistance with U.S. Import Compliance? FDAEntry.com provides comprehensive U.S. Agent services, food facility registrations, and Prior Notice support to help international companies navigate the complexities of U.S. customs. Contact our compliance team today to ensure your next shipment arrives without a hitch.