FDA Prior Notice is an advance electronic notification required for all food and animal feed imported or offered for import into the United States under the Bioterrorism Act of 2002. FDA Registration Assistance prepares and submits Prior Notices on your behalf, ensuring every filing is accurate and on time.

Prior Notice may be filed by the importer of record, a customs broker, freight forwarder, agent, or any other authorized representative — but the importer is ultimately responsible for compliance. FDA Registration Assistance acts as your authorized filing agent, taking full responsibility for preparing and submitting every Prior Notice correctly.

Prior Notice must be submitted before the shipment departs, within FDA-specified timeframes: at least 4 hours before arrival for air, 8 hours for ocean, and 2 hours for road transport. FDA Registration Assistance monitors your shipment schedule and files well ahead of every deadline, so you never miss a window.

Failure to file accurate or timely Prior Notice can result in shipment detention, refusal at the port of entry, significant delays, increased storage and demurrage costs, and FDA enforcement action. FDA Registration Assistance eliminates this risk by reviewing every detail of your shipment before submission and correcting any issues before your goods arrive.

Yes. FDA Prior Notice is required for both human food and animal food and feed shipments entering the United States. FDA Registration Assistance handles Prior Notice filings for all food categories — human food, pet food, and animal feed — ensuring full compliance regardless of product type.

A Prior Notice must include the product description and FDA product code, manufacturer and shipper details, importer information, country of origin, country where grown, anticipated port of arrival, and expected arrival date and time. FDA Registration Assistance collects and verifies all required data from you before filing, ensuring nothing is missing or incorrect.

Yes. FDA Registration Assistance is your dedicated Prior Notice filing partner. We manage the entire process — reviewing your shipment information, preparing the submission, filing electronically through the FDA Prior Notice System Interface (PNSI), and delivering your confirmation number so you can focus on your business, not FDA paperwork.

Yes. A separate Prior Notice must be filed for each individual shipment of food or animal feed entering the United States. FDA Registration Assistance manages recurring and high-volume filings for importers with ongoing operations, making the process seamless and consistent for every shipment you send.

The FDA Prior Notice System Interface (PNSI) is the official electronic system through which Prior Notices are submitted directly to the FDA. FDA Registration Assistance files all Prior Notices through PNSI on behalf of our clients, ensuring submissions are properly formatted, complete, and received by the FDA within required timeframes.

FDA Registration Assistance charges $35 per Prior Notice filing. This flat fee covers full preparation, review, and electronic submission through PNSI, as well as delivery of your FDA confirmation number. Contact FDA Registration Assistance to get started or to discuss volume pricing for ongoing import operations.

Yes. Food and animal feed shipped by international mail, courier services, or express carriers is also subject to FDA Prior Notice requirements. FDA Registration Assistance handles Prior Notice filings for all transport modes — air, ocean, road, and mail — ensuring your shipments are covered regardless of how they enter the United States.

Yes, Prior Notices can be amended or cancelled under certain conditions before the shipment arrives. FDA Registration Assistance reviews all shipment information thoroughly before every submission to minimize errors from the start, and handles any necessary amendments promptly if circumstances change after filing.

We recommend contacting FDA Registration Assistance as early as possible — ideally 24 to 48 hours before the required filing deadline. This gives our team time to thoroughly review your shipment details, resolve any discrepancies, and file well within FDA timeframes, eliminating any last-minute risk.

Prior Notice requirements apply broadly to food and animal feed imports regardless of shipment size or value, with only narrow exceptions for personal consumption items. If you are unsure whether your shipment requires a filing, FDA Registration Assistance can assess your situation and handle the submission if required — protecting you from unexpected detentions.

After a Prior Notice is accepted by the FDA, a unique confirmation number is issued. This number must accompany the shipment to the port of entry — without it, your goods may be detained. FDA Registration Assistance delivers the confirmation number to you promptly after every successful filing so your shipment documentation is always complete and ready.

Absolutely. FDA Registration Assistance specializes in managing Prior Notice filings for importers with frequent or high-volume shipments. We streamline the process by maintaining your product and facility data on file, enabling fast, accurate submissions for every shipment — reducing your administrative burden and keeping your supply chain moving without interruption.