How to File FDA Prior Notice (PNSI)

Introduction

Importing food products into the United States requires navigating a complex web of regulatory requirements. One of the most critical steps is filing a Prior Notice with the Food and Drug Administration (FDA). This notification system, implemented under the Bioterrorism Act of 2002, helps protect the U.S. food supply by giving authorities advance notice of incoming shipments.

Prior Notice is essentially an advance declaration that allows the FDA to review information about incoming food shipments before they arrive on U.S. soil. This early screening process enables officials to identify potential health and safety concerns and prepare for appropriate inspections when necessary.

For importers, brokers, and international food suppliers, understanding how to properly file FDA Prior Notice is not just about compliance—it’s about ensuring your products enter the U.S. market smoothly and without costly delays.

Requirements for Filing Prior Notice

Who Needs to File

Prior Notice must be submitted for most food products intended for consumption by humans or animals in the United States. The responsibility for filing typically falls on:

• ✔️ Importers of record
• ✔️ Customs brokers
• ✔️ U.S. agents acting on behalf of foreign shippers
• ✔️ Transmitters (individuals with authorization to submit Prior Notice)

If you’re bringing food into the United States, chances are you’ll need to file a Prior Notice—regardless of whether the shipment is commercial or non-commercial in nature.

When to File

Timing is everything when it comes to FDA Prior Notice submission. The filing window opens 15 calendar days before arrival and closes:

• ✔️ 2 hours before arrival by land via road
• ✔️ 4 hours before arrival by air or land via rail
• ✔️ 8 hours before arrival by water
• ✔️ For mail shipments, prior to sending

Meeting these deadlines is crucial—shipments without timely Prior Notice may be refused entry or held at the port.

Information Needed for Filing

To complete your Prior Notice successfully, gather these essential details:

• ✔️ Submitter and transmitter information (name, contact details)
• ✔️ Entry type and U.S. Customs entry identifier (if applicable)
• ✔️ Food product identification (FDA product code, common name)
• ✔️ Quantity and packaging description
• ✔️ Manufacturing facility information
• ✔️ Shipper details
• ✔️ Country of production
• ✔️ Expected arrival information (date, time, port)
• ✔️ Importer, owner, and consignee information

Having this information organized before starting the filing process will save you significant time and prevent potential errors.

Filing Methods

Electronic Filing

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

1. ✔️ FDA Prior Notice System Interface (PNSI) – A web-based system operated directly by the FDA, accessible through the FDA Industry Systems (FIS) portal.
2. ✔️ Automated Broker Interface/Automated Commercial System (ABI/ACS) – For commercial shipments, you can file through the U.S. Customs and Border Protection’s system, which then transmits the information to the FDA.

The method you choose often depends on your specific situation and whether you’re working with a customs broker who already uses the ABI/ACS system.

Steps to File a Prior Notice

Step 1: Create a User Account

Before filing through the PNSI, you’ll need to:

1. ✔️ Visit the FDA Industry Systems website
2. ✔️ Create a new account (if you don’t already have one)
3. ✔️ Request access to the Prior Notice System Interface
4. ✔️ Wait for account activation (typically within 24 hours)

Step 2: Gather Necessary Information

Collect all the details mentioned in the “Information Needed” section above. Having complete and accurate information ready will streamline the filing process significantly.

Step 3: Access the Prior Notice System Interface

Once your account is active:

1. ✔️ Log in to the FDA Industry Systems portal
2. ✔️ Select the Prior Notice System Interface
3. ✔️ Choose “Create New Prior Notice”

Step 4: Complete the Online Form

The PNSI will guide you through several sections:

1. ✔️ Provide entry details and product information
2. ✔️ Enter manufacturer information
3. ✔️ Add shipper details
4. ✔️ Input arrival information
5. ✔️ Include importer and consignee details

Be methodical and precise—any inaccuracies could lead to delays or rejections.

Step 5: Review Submission

Before submitting, carefully review all entered information. Pay particular attention to:

• ✔️ Product descriptions and codes
• ✔️ Quantities
• ✔️ Manufacturing facility details
• ✔️ Arrival dates and times

Step 6: Submit the Prior Notice

Once you’ve verified all information is correct, submit the Prior Notice. The system will process your submission in real-time.

Step 7: Receive Confirmation

Upon successful submission, the system will generate a Prior Notice Confirmation Number (PN Confirmation Number). This number is vital—it serves as proof that you’ve complied with the Prior Notice requirement and must be provided to U.S. Customs and Border Protection upon arrival of your shipment.

Print or save this confirmation for your records and to present to officials when required.

Important Notes

Penalties for Non-compliance

Failing to file FDA Prior Notice or submitting inaccurate information can result in:

• ✔️ Refused entry for the shipment
• ✔️ Detention of products at the port
• ✔️ Storage fees and additional costs
• ✔️ Potential civil monetary penalties
• ✔️ Placement on import alert lists for repeat offenders

Exemptions from Filing

Some products and situations are exempt from Prior Notice requirements, including:

• ✔️ Food imported by an individual for personal consumption
• ✔️ Food that is transiting through the U.S. (not intended for consumption in the U.S.)
• ✔️ Food for diplomatic or military use
• ✔️ Food samples for research purposes (not for consumption)
• ✔️ Certain food contact substances

Amendments and Cancellations

If details change after submission but before the shipment arrives:

• ✔️ You may need to amend your Prior Notice
• ✔️ If a shipment is canceled, the Prior Notice should be canceled as well
• ✔️ Amendments must be made within the same timeframes as original submissions

Tips for a Smooth Filing Experience

Common Mistakes to Avoid

Based on our experience helping clients with FDA Prior Notice and FSVP services, here are pitfalls to watch for:

1. ✔️ Incomplete manufacturer information: Ensure you have complete facility details, including registration numbers if required.
2. ✔️ Incorrect product codes: Using the wrong FDA product code can trigger unnecessary scrutiny or inappropriate review.
3. ✔️ Mismatched quantities: The quantity in your Prior Notice should match your commercial documents exactly.
4. ✔️ Last-minute submissions: Filing too close to deadlines leaves no buffer for technical issues or information gaps.
5. ✔️ Inconsistent product descriptions: Descriptions that don’t match commercial paperwork raise red flags.

Best Practices for Accurate Submission

• ✔️ Create a template for frequent shipments to save time and ensure consistency
• ✔️ Set internal deadlines well ahead of FDA requirements to account for potential issues
• ✔️ Keep a database of product codes and manufacturer information for quick reference
• ✔️ Double-check all automated or pre-filled information before submission
• ✔️ Train multiple team members on the filing process to ensure coverage

Resources

FDA Prior Notice FAQ

The FDA maintains a comprehensive FAQ page that addresses common questions about Prior Notice requirements and procedures.

FDA PNSI Tutorial

First-time users should review the FDA’s step-by-step tutorial for navigating the PNSI system.

Additional References and Contacts

• ✔️ FDA Help Desk: 1-800-216-7331 or 301-575-0156
• ✔️ FDA Prior Notice Center: 866-521-2297
• ✔️ Email: FURLS@fda.gov (for account issues)

Conclusion

Filing FDA Prior Notice is a crucial step in the food import process that directly impacts your ability to bring products into the United States. While the process may seem daunting at first, breaking it down into manageable steps makes compliance achievable.

Remember that timing is critical—late or incomplete Prior Notice submissions can result in refused shipments, delays, and additional costs that impact your bottom line and customer relationships. The key to success is preparation, attention to detail, and staying informed about any regulatory changes.

Need help ensuring your FDA Prior Notice submissions are accurate and timely? Global Import Agent specializes in streamlining the FSVP compliance process for food importers and international suppliers. Our team of FDA regulatory experts can handle your Prior Notice filings, verify product classifications, and ensure your documentation meets all FDA requirements—eliminating the risk of costly border delays and detentions.

We’ve helped hundreds of food companies successfully navigate FDA Prior Notice requirements while keeping their supply chains running smoothly. Whether you need one-time assistance or ongoing support for regular shipments, our affordable, technology-driven solutions can save you time and prevent compliance headaches.

If you have any questions or need assistance, contact us today for a free consultation about your specific import needs, and discover how we can make your FDA compliance process simpler and more reliable.