Global Import Agent

FDA Prior Notice Filing

Prior notice tells FDA in advance about food being imported or offered for import into the United States. It must be submitted and confirmed before arrival: at least 2 hours ahead by road, 4 hours by rail or air, and 8 hours by water (21 CFR 1.279). Global Import Agent files prior notice for your shipments.

· By the Global Import Agent team
Overview

When must prior notice be submitted?

The deadline depends on how the shipment reaches the United States.

TransportMinimum notice
RoadAt least 2 hours before arrival
RailAt least 4 hours before arrival
AirAt least 4 hours before arrival
WaterAt least 8 hours before arrival
  • A PNSI submission can be made no more than 15 calendar days before anticipated arrival; an ABI/ACE submission no more than 30 calendar days before anticipated arrival (21 CFR 1.279(b)).
  • For international mail, prior notice must be submitted before the food is sent (21 CFR 1.279(c)).
Cargo containers moving through an international port

Filing & Submission of FDA Prior Notice

We handle all aspects of Prior Notice filing so your documentation is submitted correctly and within the required timeframes.

  • Electronic submission of Prior Notice to the FDA and CBP
  • Verification of correct product classification and documentation
  • Filing within the required timeframe before your shipment arrives

Review & Correction of Prior Notice Filings

Mistakes in Prior Notice filings can lead to detentions or refused entry, so we review and correct errors before submission.

  • Cross-checking product descriptions, codes, and shipment details
  • Ensuring FDA food facility registration numbers are valid
  • Correcting errors in shipper, importer, and consignee details
Product documentation being reviewed for compliance
Food & Beverage

Prior Notice Filing

Expedited & Emergency Prior Notice Filing

If your shipment is already in transit without a Prior Notice, we help you submit one before it arrives.

  • Rush filing of Prior Notice to prevent customs delays
  • Direct coordination with FDA and CBP officials
  • Real-time tracking and status updates through to clearance

Prior Notice Filing for Perishable & High-Risk Products

Perishable goods, dairy, seafood and meat substitutes face stricter FDA scrutiny, so we handle the additional safety and documentation requirements.

  • Priority filing for temperature-sensitive and perishable goods
  • Compliance with USDA and APHIS regulations for dual-regulated imports
  • Submission of additional safety certifications, if required

Prior Notice Filing Compliance Training

For companies that import food and beverages regularly, we offer training so your team can file Prior Notice correctly and avoid penalties.

  • Step-by-step guidance on Prior Notice filing procedures
  • Identifying common mistakes and compliance risks
  • Ongoing support and updates on FDA regulatory changes

Food & Beverage Facility Registration

We handle the full facility registration process for food, beverage, dietary supplement and cosmetic facilities.

  • Preparing and submitting your FDA facility registration
  • Ensuring accuracy in facility details to avoid delays or errors
  • Managing renewals during the biennial renewal period

Ongoing compliance support

  • Time-Saving

    We prepare and submit each Prior Notice, so your team isn't tied up with repetitive filings.

  • Regulatory Assurance

    Filings are checked against product, facility and shipment details before submission.

  • Peace of Mind

    Reduce the risk of holds, refusals and extra scrutiny caused by missing or incorrect notices.

What you'll need

Prior Notice depends on accurate shipment data, filed before arrival.

  • Product descriptions and codesCorrect classification for every line in the shipment.
  • Valid facility registration numbersFor the facilities that made the food.
  • Shipper, importer and consignee detailsNames and addresses that match your documents.
  • Shipment timingArrival details so filing happens within the required window.

Official sources

Client feedback

Trusted support, in our clients’ own words.

“Global Import Agent have successfully worked with me to land product in the U.S and remain compliant for FDA regulations. I'm really happy with their response times, and easy to use tech platform that facilitates the process.”
Jane MckayAstute Beverages
Frequently asked questions

Prior Notice Filing

Requirements vary by product and destination. These answers outline the starting point for the questions we receive most often.

Ask our team

Who needs to file Prior Notice with the FDA?

Any importer, customs broker, or shipper bringing food, beverages, or dietary supplements into the U.S. must file Prior Notice before arrival.

How far in advance should Prior Notice be filed?

  • For shipments arriving by air or truck: At least 4 hours before arrival.
  • For shipments arriving by sea: At least 8 hours before arrival.
  • For shipments by mail or express courier: Prior Notice must be filed before dispatch.

What happens if I don’t file Prior Notice?

  • Your shipment may be held at customs or refused entry.
  • The FDA may detain your products for compliance review.
  • You may be subject to penalties and additional scrutiny on future shipments.

Can Prior Notice be filed for multiple shipments at once?

  • Yes, batch filings are possible for high-volume importers.
  • We provide bulk submission services for frequent shipments.

Can Prior Notice be corrected after submission?

  • Yes, minor corrections can be made if caught before the shipment arrives.
  • If an error is detected after arrival, we can assist in resolving compliance issues with FDA and CBP.

What if my shipment is already en route without Prior Notice?

  • We offer emergency filing services to submit Prior Notice before arrival.
  • If the shipment has already arrived, we work with FDA officials to expedite resolution.
Discuss your requirements

Talk through your product and target market with our team.

Consultation

Tell us what you need to import.

Share your product, target market and compliance question. A member of our team will respond promptly.

Scope your product and target market
Identify the applicable regulatory route
Receive a clear proposal and next steps