Food and Drug Administration Prior Notice (FDA PN)

Easy declaration of food and feed import to US

Who needs Food and Drug Administration Prior Notice (FDA PN)
 

Food and Drug Administration Prior Notice (FDA PN)

The US Food and Drug Administration (US FDA) requires the electronic filing of Prior Notice for all human and animal food, beverage, and dietary supplements shipments entering the US. Upon receipt of Prior Notice, FDA will issue a confirmation number in the form of a bar code that must accompany the food shipments.

The FDA must receive and validate the pre-arrival Prior Notice within mode-specific time frames:

  • Highway: 2 hours before arrival.
  • Rail: 4 hours before arrival.
  • Air: 4 hours before arrival.
  • Ocean: 8 hours before arrival.

Note: Prior Notice is not required for home-made non-commercial food shipments shipped by an individual, to an individual, as gifts for personal use. The current FDA policy does not require Prior Notice for food purchased at a commercial establishment is exported or offered for export by a non-commercial shipper for a non-commercial purpose (i.e., from an individual, to an individual, as a gift or as a household good for personal use). Additional exclusion criteria can be found on the FDA website.

Benefits

Easy-to-use web application

User friendly platform makes for effortless filing with smart validation, fast uploads, and instant responses.

Efficient

Act on responses immediately upon receiving direct responses from FDA.

Enhanced accuracy

Eliminate duplicated data entries and reduce errors through a comprehensive system validation.

Affordable plans

Multiple pricing plans for businesses of various sizes and needs. Choose from user friendly web based service, integration, or managed filing services.

Save time

"Basket" allows population of a large number of items in a box or basket and automatically create multiple FDA PN transactions for each product in the basket.

24/7 Customer support

Our 24/7 expert customer support is conveniently available for you around the clock via email, live chat and phone.

How to get started

How does it work?

  1. Prior Notice to FDA must be submitted electronically either through the US Customs and Border Protection’s (CBP’s) Automated Broker Interface of the Automated Commercial System (ABI/ACS) or FDA’s Prior Notice System Interface (PNSI).
  2. Both the CBP ABI/ACS and the FDA PNSI are available 24 hours a day, 7 days a week for information submission.
  3. The filer must include the following information on all documentation for food shipments:

    • FDA food facility registration number.
    • Name and address of the manufacturer.
    • Last place the product was stored, packed or processed.
  4. Any individual with the required information, including importers/exporters, brokers and US agents, may submit the Prior Notice.
  5. If using the services of a customs broker, importers should provide their broker with a copy of the food label and ingredients list for clearance purposes. In this case, the broker is responsible for preparing and filing the formal entry and the Prior Notice for the food shipment. The broker must submit the Prior Notice confirmation number to CBP. The barcoded Prior Notice confirmation number must also be shown on the airway bill, bill of lading, and other shipping documents.

Note: CBP will hold food shipments if there is no proof that the importer has filed a Prior Notice with the FDA. We recommend having food shipments cross the border during FDA business hours to allow for inspection at the port of arrival.

FDA Price Plans

GeTS’ eManifest solutions make the filing process quick and simple. Choose from a selection of flexible pricing options for web filing, integration to in-house systems, or let our team of expert compliance professionals file on your behalf.

Food and Drug Administration Prior Notice (FDA PN)

Web Services

Basic

$ 39 Monthly
  • 39 Transactions
  • $1.00 per Additional Transaction

Lite

$ 79 Monthly
  • 92 Transactions
  • $0.85 per Additional Transaction

Plus

$ 149 Monthly
  • 212 Transactions
  • $0.70 per Additional Transaction

Enterprise

$ 499 Monthly
  • 907 Transactions
  • $0.55 per Additional Transaction

Premium

$ 999 Monthly
  • 2497 Transactions
  • $0.40 per Additional Transaction

Filing Service

Filing

$ 50 Monthly
  • 5 Transactions
  • $8 per Additional Transaction

* Pay-per-use: Filing Service $10 per Shipment.

* Integration Option: One-time Integration Fee $2000 (Includes mailbox for host-to-host EDI/XML integration option).

Interested to learn more?

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