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World's Leading FDA Compliance Experts

Prior Notice: When and How to Submit

Nov 3, 2022

The U.S. Food and Drug Administration (FDA) requires the filing of Prior Notice for all food, beverage, and dietary supplements shipments entering the United States. Prior Notice provides FDA with important information about food shipments arriving into the U.S., helping FDA to ensure food safety for humans and animals.  

Shipments without Prior Notice will likely be detained at the U.S. port of entry and the food is subject to refusal. These shipments may be returned to the shipper or destroyed. FDA considers not filing Prior Notice a “Prohibited Act,” subject to civil and criminal charges.  

FDA has strict guidelines regarding when to submit Prior Notice and the information that must be included in each submission.  

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists can help you file Prior Notice with FDA quickly and properly.

For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day: www.registrarcorp.com/livechat.

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Prior Notice Timelines

Because FDA uses Prior Notice submissions to best decide where their inspectors need to be, Prior Notice must be submitted and confirmed by FDA no less than:

  • 2 hours prior to arrival for shipments arriving by road
  • 4 hours prior to arrival for shipments arriving by rail
  • 4 hours prior to arrival for shipments arriving by air
  • 8 hours prior to arrival for shipments arriving by water

If your shipment is arriving by international mail or express couriers, you should submit Prior Notice before shipping the package.

Ready for help with your Prior Notice submissions? Discover Registrar Corp’s FDA registration services.

FDA Prior Notice Required Information

FDA requires numerous pieces of information to accompany each Prior Notice. Your submissions should include the following:

  • Information about the Manufacturer, Submitter, Transmitter, Shipper, and the Importer, Owner or Ultimate Consignee
  • Identification of each product in the shipment, which can be completed by providing the following: FDA Product Code, common product name, estimated quantity, and product weight
  • Carrier and mode of transportation
  • Anticipated time of arrival (port of entry time) – this time should refer to the docking time for vessels, the landing time for airplanes, or the expected border crossing time for land vehicles
  • If applicable, the name of any country to which the product has been refused entry, as required under the Food Safety Modernization Act (FSMA)

When submitting Prior Notice through FDA’s Prior Notice System Interface (PNSI), you may submit no more than 15 calendar days before the shipment is due to arrive. If you are using the Automated Broker Interface/Automated Commercial System (ABI/ACS), you may submit no more than 30 calendar days before the shipment is due to arrive. You can also file Prior Notice through Registrar Corp’s Prior Notice Express, which allows you to save and store your information online, reduce filing time, and decrease potential filing errors.

Anyone with knowledge of the shipment can submit Prior Notice, including shippers, importers, U.S. Agents, and customs brokers. Upon receipt of Prior Notice, FDA will issue a confirmation number in the form of a barcode, which must accompany most food shipments.

Prior Notice is also required for trade show samples and live animals that may be eventually consumed.

FDA Registration

Each time you file Prior Notice, you must include a valid registration number for the product’s manufacturer. If a company fails to renew their FDA registration during a renewal period, FDA will cancel their registration. Many times, companies do not realize their registration was canceled until they have an issue with a shipment, often realizing when they attempt to submit Prior Notice. If a registration number is invalid, the Prior Notice will be immediately rejected in the Prior Notice portal.

Submitting Prior Notice in accordance with FDA’s requirements is one task you can complete to help your shipments enter the U.S. more smoothly.

 

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists can help you file Prior Notice with FDA quickly and properly.

For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day: www.registrarcorp.com/livechat.

Get Assistance

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Registrar Corp

World's Leading FDA Compliance Experts

Registrar Corp thrives on the collective expertise of over 200 professionals, including former FDA officials and experienced industry specialists. Our team of regulatory specialists is our greatest asset, offering deep insights into the latest and longstanding FDA regulations. With our simple, straightforward, and actionable articles, you can navigate the complex regulatory landscape with ease.

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