Prior Notice Filing for Food Imports

What Is FDA Prior Notice for Food Imports?

Prior Notice is an FDA requirement established by the Bioterrorism Act of 2002. It requires advance notification to FDA of any food (including animal feed) imported or offered for import into the United States. The purpose is to give FDA advance information about imported food shipments for risk assessment and to help respond to potential food safety or bioterrorism threats.

Every shipment of food entering the United States requires Prior Notice - there are no dollar value minimums or quantity exceptions. Even small personal shipments and samples require Prior Notice unless specifically exempted.

When Must Prior Notice Be Filed?

The timing of your Prior Notice filing depends on how the food is being transported. FDA has set minimum advance notification requirements based on the mode of transportation:

Maximum Filing Time

Prior Notice cannot be filed more than 15 days before the anticipated date of arrival. If you file too early and the shipment is delayed beyond 15 days from your original filing, you may need to cancel and refile.

What Information Is Required for Prior Notice?

Prior Notice requires comprehensive information about the shipment. Having all information ready before filing prevents delays and errors.

Submitter Information

• Name of individual submitting Prior Notice
• Email address
• Phone number
• Fax number (optional)

Transmitter Information (if different from submitter)

• Name of transmitting firm
• Transmitter identification (Filer ID, ABI Filer Code, or FDA Prior Notice confirmation number)

Entry Information

• Entry type code
• CBP entry identifier (for formal entries)
• Mode of transportation
• Anticipated arrival information

Article Information

• Product code: FDA product code describing the food
• Common/market name: How the food is commonly known
• Quantity: Amount being imported
• Packaging: Type of packaging
• Lot/batch information: For traceability

Manufacturer Information

• Manufacturer name and address
• FDA registration number (required for registered facilities)

Shipper Information

• Shipper name and address
• Country

Grower Information (for produce)

• Grower name and address (if known)
• Country of growing

Carrier/Conveyance Information

• Carrier name
• Planned shipment information
• Conveyance type (vessel name, flight number, truck/rail carrier)
• Mail tracking number (required for international mail shipments effective October 1, 2026; per Federal Register 2025-18655)

How Do I File Prior Notice with the FDA?

There are two primary methods for filing Prior Notice with FDA:

FDA Prior Notice System Interface (PNSI)

The FDA's web-based interface allows direct Prior Notice submission:

• Accessible through FDA Industry Systems
• Free to use
• Suitable for low-volume importers
• Confirmation number provided immediately upon submission

Automated Broker Interface (ABI)

For high-volume importers, Prior Notice can be filed through the Customs and Border Protection ABI system:

• Integrated with customs entry filing
• More efficient for large volumes
• Requires ABI certification
• Typically used through customs brokers

What Happens After Filing Prior Notice?

Upon successful Prior Notice submission, you receive a Prior Notice Confirmation Number. This number is critical:

• Must be provided to CBP at the time of entry or arrival
• Links the food shipment to the Prior Notice filing
• Required for the food to be released

Confirmation Status

Prior Notice confirmations have two possible statuses:

• Confirmed: The Prior Notice has been accepted and the article may be offered for import
• Confirmed: Additional Review Needed: FDA needs to review the shipment further (this doesn't mean the shipment will be refused)

What Are the Most Common Prior Notice Errors?

Avoid these frequently made mistakes that can delay your shipments:

Who Is Exempt from Prior Notice Requirements?

Certain foods are exempt from Prior Notice requirements:

• Food for personal use: Food in personal baggage accompanying an individual arriving in the US (with some restrictions)
• Diplomatic pouches: Food transported in official diplomatic pouches
• Meat, poultry, and egg products: Products under USDA jurisdiction (these have separate USDA requirements)
• Transshipments: Food that remains in the same conveyance through the US without being unloaded

What Happens If I Don't File Prior Notice?

Failure to submit Prior Notice or submitting inaccurate Prior Notice can result in serious consequences:

• Refusal of admission: Food may be refused entry into the United States
• Detention: Food may be held pending resolution
• Re-exportation costs: Non-compliant shipments must be exported at importer's expense
• Potential destruction: If not re-exported within timeframes, food may be destroyed
• Future scrutiny: Repeated violations may increase scrutiny of future shipments

How Can High-Volume Importers Streamline Prior Notice?

If you regularly import food products, these strategies can streamline your Prior Notice process:

Use Established Templates

For regular shipments of the same products, create templates in the PNSI system with pre-filled information. Only update variable data like dates and quantities.

Work with Your Customs Broker

Most customs brokers file Prior Notice as part of their entry services. Establish clear communication channels and provide them with accurate product and supplier information.

Maintain Supplier Information Database

Keep an updated database of:

• Foreign supplier FDA registration numbers
• Complete addresses for manufacturers and shippers
• FDA product codes for all products you import
• Historical shipment data for reference

Consider Third-Party Software

Various compliance software solutions integrate Prior Notice filing with your supply chain management, automating much of the process.

What Should I Check Before Filing Prior Notice?