File Prior Notices online quickly and easily.
The U.S. Food and Drug Administration (FDA) requires advance notice of all food, beverage, and dietary supplement shipments entering the U.S. Our Prior Notice services are bespoke solutions that streamline the filing process so you can focus on bringing your product to market.
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Prior Notice Timelines
Advance notice of imported shipments lets FDA target inspections more efficiently and better prevent public health emergencies. FDA has strict submission guidelines for when to submit Prior Notices, depending on how products are being shipped.
Prior Notices must be submitted and confirmed by FDA no less than:
4 hours before arrival by rail
4 hours before arrival by air
8 hours before arrival by water
If your shipment is arriving by international mail or express couriers, you should submit Prior Notice before sending the package.
You may submit Prior Notice up to 15 calendar days before shipment arrival through FDA’s Prior Notice System Interface (PNSI), or up to 30 calendar days if you file through the Automated Broker Interface/Automated Commercial System (ABI/ACS) through a broker.
Prior Notice Required Information
FDA requires you to provide additional documentation with each Prior Notice.
Submissions should include:
Information about the manufacturer, submitter, transmitter, shipper, and the importer, owner, or ultimate
consignee
Identification of each product in the shipment, which includes its FDA Product Code, common product name, estimated quantity, and product weight
Carrier and mode of transportation
Anticipated time of arrival or port of entry time, which may mean docking, landing, or expected border crossing time depending on your shipment’s mode of transportation
The name of any country the product has been refused
entry to, as required under the Food Safety Modernization Act (FSMA)
Value of Prior Notice Express
Save time and get more done by filing multiple Prior Notices at once with our Prior Notice Express service. Prior Notice Express allows you to save and store your information securely online, decreases potential filing errors, and reduces your filing time by 50%.
Simply create Prior Notice Express account to get started.
Registrar Corp’s Prior Notice Pricing
You can purchase a single Prior Notice filing or
blocks of filings at a discounted rate:
One (1)
Prior Notice Filing
$19.95
Ten (10)
Prior Notice Filing
$17.95 each
10% discount ($179.50 USD)
Twenty-Five (25)
Prior Notice Filing
$14.95 each
25% discount ($373.75 USD)
To use blocks of Prior Notice filings, you must create a Prior Notice Express account.
Frequently Asked Questions
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires that FDA receive prior notification of food, animals, beverages, and dietary supplements, including animal feed that is imported or offered for import into the United States.
Foreign suppliers of food, beverages, and dietary supplements entering the U.S. must submit an advance filing with information on each product and shipment, a process called Prior Notice.
This allows FDA to better target import inspections and protect U.S. public health.
The U.S. Customs and Border Protection (CBP) also protects the U.S. food supply and public health at national borders with FDA. But CBP requires different documentation of incoming shipments called the Importer Security Filing (ISF) or 10+2. These are only required for inbound ocean shipments by vessel.
Failure to provide FDA a Prior Notice in a timely manner will result in the food, beverage, or dietary supplement shipment being denied entry until errors are corrected. Companies could also be fined by FDA for failing to provide Prior Notice.