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FDA Prior Notice is a mandatory requirement for all food shipments imported or offered for import into the United States. It requires importers to submit detailed information to the FDA before the shipment arrives, ensuring regulatory compliance and facilitating smooth inspections. This process helps the FDA manage food safety risks and protect public health by having advance knowledge of incoming products.

The notice includes information about the product, shipper, consignee, and other key details. Failure to submit prior notice can result in shipment delays or refusals at the border. Importers use FDA systems like the Prior Notice System Interface (PNSI) or other submission services to file the required information efficiently.

Understanding the FDA Prior Notice process is essential for anyone involved in food importing. Meeting these requirements reduces the risk of non-compliance and supports the timely clearance of shipments into the U.S.

Understanding FDA Prior Notice

FDA Prior Notice is a mandatory step for all food imports entering the United States. It ensures the FDA receives advance details about shipments to manage safety and compliance efficiently.

Definition and Purpose

FDA Prior Notice is the requirement that importers notify the FDA before food shipments arrive at a U.S. port. This alert allows the FDA to review incoming products to prevent unsafe or misbranded food from entering the country.

The purpose is to protect public health by giving the FDA time to assess risks, coordinate inspections, and ensure regulatory compliance. Both human and animal foods are subject to this rule, except those specifically excluded.

This system supports faster customs clearance by reducing delays caused by inspections or paperwork issues at the port of arrival.

Legal Requirements

Under Title 21 CFR Part 1, Subpart I, every shipment of food for consumption by humans or animals must have Prior Notice submitted electronically before reaching the U.S.

The FDA must receive this notice and confirm it before the shipment arrives at the first U.S. port. Failure to submit in time or provide accurate information can result in refusal, detention, or penalties.

Key required details include:

• Identification of the shipper and consignee
• Description of the food product
• Expected arrival date and entry point
• Shipment quantity and origin

These details ensure traceability and quick FDA access to critical shipment information.

Who Must Submit Prior Notice

The responsibility to submit Prior Notice typically lies with the importer of record. This can be the U.S. owner, consignee, or the agent responsible for importing.

If no U.S. agent is designated, the foreign shipper or shipper’s customs broker may file the notice. However, importers often use brokers or specialized software to ensure compliance.

All parties involved in the shipment should verify that Prior Notice is submitted on time to avoid delays or shipment refusal at the port.

FDA Prior Notice Process

The FDA Prior Notice process requires importers to electronically submit detailed information before food shipments arrive in the U.S. This ensures the agency can review and confirm the shipment in advance, enhancing food safety and regulatory compliance.

How to Submit Prior Notice

Prior Notice must be submitted electronically using the FDA’s Prior Notice System Interface (PNSI) or through a customs broker’s portal that supports this system. The submission must occur before the food arrives at the first U.S. port of entry.

The timing depends on the mode of transportation:

• Land shipments: at least 2 hours before arrival
• Air shipments: at least 4 hours before arrival
• Vessel shipments: at least 8 hours before arrival

Once submitted, the FDA must confirm receipt. Without confirmation, the shipment may be delayed or refused entry.

Information Required for Submission

The submission must include specific details such as:

• The identity of the product (e.g., common name, description)
• Manufacturer and shipper information
• Importer or consignee details
• Shipment information (arrival date, mode of transportation)
• Country of origin and any relevant lot or batch numbers

Accurate, complete information helps avoid processing delays and ensures compliance with FDA regulations.

Consequences of Non-Compliance

Failure to provide Prior Notice or submitting incorrect information can lead to significant consequences. These include:

• Detention or refusal of the shipment at U.S. ports
• Increased inspection rates for future shipments
• Possible penalties or fines on the importer or responsible party

Non-compliance can disrupt supply chains and result in additional costs and delays.

Tips for Accurate Prior Notice Filing

To ensure smooth processing, importers should:

• Verify all shipment details before submission
• Submit Notice within the required timeframes based on transport mode
• Use the FDA’s PNSI or accredited software to reduce errors
• Maintain records of Prior Notice submissions for at least 6 months

Consistently accurate filings minimize risk and help maintain timely customs clearance.