7 Tips for Successful FDA Prior Notice Filing

What Is Prior Notice and Who Must File

The Prior Notice requirement was established by the Bioterrorism Act of 2002 and strengthened by FSMA. It requires advance notification to FDA for every shipment of food (including beverages, dietary supplements, and animal feed) that is imported or offered for import into the United States.

Prior Notice can be filed by the importer, the importer's agent, the customs broker, or the foreign shipper. In practice, customs brokers file most Prior Notices, but the importer is ultimately responsible for ensuring it is filed correctly and on time.

Filing Deadlines by Transportation Mode

One of the most critical aspects of Prior Notice is meeting the correct filing deadline. Deadlines vary based on how the food is being transported into the United States. Filing too late will result in your shipment being refused at the port.

Our Deadline Calculator can help you determine exact filing deadlines based on your shipment details and transportation mode.

Required Information for Prior Notice

A Prior Notice filing requires extensive information about the shipment. Having all of this ready before you start the filing process saves significant time and reduces errors:

• Product description: FDA product code, common or market name, and complete quantity information with unit of measure
• Manufacturer information: Name, address, and FDA registration number of the manufacturer or processor
• Shipper information: Name, address, and country of the person who shipped the food
• Grower information: If known, the name, address, and country of the grower (required for produce and some raw agricultural commodities)
• Country of origin: The country where the food was produced or manufactured
• Arrival information: Port of entry, date and time of arrival, and mode of transportation
• Carrier information: Name of the carrier and conveyance details
• Importer/consignee: Name, address, and IRS Employer Identification Number or DUNS number

Top 7 Filing Mistakes That Cause Detention

Based on our experience helping importers across 160+ countries, these are the most common Prior Notice mistakes that lead to shipment detentions:

1. Wrong product code: Selecting the incorrect FDA product code is the single most common error. Each product must be classified to the specific FDA product code, not a general category.
2. Missing or expired facility registration: The manufacturer's FDA facility registration must be active and valid at the time of filing. An expired registration will trigger automatic refusal.
3. Incorrect manufacturer information: The manufacturer name and address on the Prior Notice must exactly match the FDA registration. Even minor discrepancies can cause holds.
4. Late filing: Filing after the minimum time requirement or too close to the deadline. Build in buffer time, especially for ocean shipments.
5. Incomplete shipper/grower information: Omitting required fields for the shipper or grower will trigger a rejection. Gather this information well before the shipment date.
6. Quantity mismatches: The quantity and unit of measure on the Prior Notice must match the actual shipment. Discrepancies will be flagged during review.
7. No confirmation number: After filing, you receive a PN confirmation number. This number must be provided to the customs broker for entry. Without it, the shipment cannot clear customs.

What Happens When Prior Notice Is Refused

If your Prior Notice is refused or your shipment is detained due to a Prior Notice issue, the consequences can be significant:

If your shipment is currently on hold, visit our shipment on hold guide for step-by-step instructions on resolving the issue quickly.

Best Practices for Smooth Filings

After helping thousands of importers file successful Prior Notices, here are our top recommendations for avoiding delays:

• File early: Do not wait until the minimum deadline. File as early as possible (up to 15 days before arrival) to allow time for corrections if needed.
• Verify registration status: Before every filing, confirm that the manufacturer's FDA facility registration is current. Registration can lapse if not renewed on time.
• Use consistent naming: The manufacturer name and address on the Prior Notice must exactly match the FDA registration. Create a reference document with the exact information to use for every filing.
• Double-check product codes: Use our Product Code Lookup to verify the correct code. When in doubt, call FDA's Prior Notice Center at 1-866-521-2297 for guidance.
• Keep confirmation numbers: Save the PN confirmation number immediately after filing and share it with your customs broker before the shipment arrives.
• Track your filings: Maintain a log of all Prior Notice filings with dates, confirmation numbers, and shipment details for easy reference and audit purposes.
• Use bulk filing for repeat shipments: If you import the same products regularly, consider using the ABI system through your customs broker for automated filing.

Tools and Resources

Assurentry provides several tools to help you with Prior Notice filing and overall food import compliance:

For a complete overview of Prior Notice requirements, read our Prior Notice filing guide or explore our food import services.