What is Considered “Food” Under the FDA PN Regulations?

“Food” is defined as Food or drink for humans or other animals; chewing gum; and articles used for components of any such articles (excluding food contact substances and pesticides).

Who Can Send FDA PN?

Any individual with knowledge of the required information — including manufacturers, exporters, brokers, importers, and U.S. agents.

Carriers
(rail, truck, ship, air)

Importers of Food

Exporters of Food

Customs Brokers

Manufacturers & Growers

FDA Prior Notice (PN) Data Elements

FDA PN Exemptions

When to Submit FDA PN?

No more than 30 days before a shipment arrives

For Shipments Arriving:

Prior Notice Must Be Submitted:

Watch a Demo of the FDA PN System

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4 Reasons to Clear your FDA PN eCommerce Shipments using CustomsCity

FDA PN (PRIOR NOTICE) FAQs

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take additional steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.

Along with other provisions, the Act requires that the US FDA Prior Notice should be given in advance on FDA imports including animal feed that is imported or offered for import into the United States. Advance notification of FDA imports allows the FDA, with the support of the U.S. Customs and Border Protection (CBP), to target import inspections more effectively and help protect that nation’s food supply against terrorist acts and other public health emergencies.

US FDA Prior Notice is required for FDA imports of human and animal food importations and food transiting through the United States unless an exemption under the FDA regulation applies.

US FDA Prior Notice of FDA imported food shipments will give FDA time to:

  • Review and evaluate information before an FDA food product arrives in the U.S. as an FDA import.
  • Better deploy resources to conduct inspections.
  • Help intercept contaminated products shipped with FDA Prior Notice.

FDA must electronically receive and confirm US FDA Prior Notice before a food shipment arrives at the first port in the United States (port of arrival). The deadline for submitting an FDA Prior Notice depends on the mode of transportation used for FDA import shipments.  

Except in the case of food arriving by international mail, FDA must receive and confirm a Prior Notice:

1) no more than 30 days before a shipment arrives, if FDA Prior Notice is submitted via ABI/ACE: or

 2) no more than 15 days before a shipment arrives if a US FDA Prior Notice is submitted via FDA’s PNSI portal.

The following commodities are excluded from the FDA prior notice requirements of FDA import regulations:

  • Personal food and/or gifts (non-commercial purpose) accompanying or shipped by an individual for FDA import.
  • Merchandise that is immediately exported (IEs).
  • Meat, poultry, and egg products that are exclusively under the USDA jurisdiction.
  • Homemade goods shipped as gifts.
  • Food items shipped via diplomatic pouch.
  • Foods that are normally subject to the BTA/FDA regulations are shipped as personal effects (household goods).
  • Non-consumption samples for testing only.

When a prior notice FDA web entry is filed for an FDA import, the government may decide to provide a Notice of FDA Action to the filer, importer, owner, and/or consignee when the FDA decides to examine or collect a sample. The Notice of FDA Action: Advises that the entry is to be held for an FDA examination or sampling; and specifies the items (lines) in the entry that need to be held.  

FDA Prior Notice web entry data must be electronically submitted, and confirmation issued by the FDA for FDA imports before the clock starts.  The pre-filing times are dependent upon the mode of transportation for the goods. The minimum time limits are:

  • Truck/Pedestrian/Cart/Car: 2 hours before arrival
  • Air/Rail: 4 hours before arrival
  • OceanVessel: 8 hours before arrival

When CBP detects this sort of violation in a prior notice FDA import shipment, the consequences for smuggling can be substantial.  CBP has existing and sufficient enforcement authority in this type of matter.  All food merchandise submitted under the FDA PN may be seized and can be subjected to forfeiture.  The violators may face significant penalties or liquidated damage claims. In certain cases, the violators may be criminally prosecuted. Upon conviction, the FDA may disbar someone from ever importing food items into the United States.  CBP may also apply significant civil monetary penalties to anyone who knew, assisted, or aided in the unlawful importation of these violative goods.

FDA recommends that a Prior Notice of FDA confirmation accompanies any shipment of imported food.

If an FDA Import Shipment Arrives…

By commercial carrier

If the Prior Notice web entry was submitted through the FDA PNSI, the carrier must have the Prior Notice web entry confirmation number. In other cases, it is prudent for the carrier to have a copy of Prior Notice confirmation or the confirmation number in his/her possession when arriving at the port of arrival.

By international mail

The FDA import package must bear the Prior Notice web entry confirmation number.

Carried by or otherwise accompanying an individual arriving in the U.S.

The individual must have a copy of the Prior Notice web entry FDA confirmation number

FDA PN Monthly Price Plans

Pricing is per transaction sent to CBP on a monthly basis. Responses received by CBP and sending updates or deletes to CBP are not charged. ISF counts as a transaction. Download ACE Ocean LOI below and email completed form to info@customscity.com

  • Select your plan

  • Number of included transactions

    Number of included transactions

  • Average price per transactionAverage price per transaction
  • Counts as transactionsCounts as transactions
  • CBP Responses included at no chargeCBP Responses included at no charge
  • 24/7 Support24/7 Support
  • On-Boarding AssistanceOn-Boarding Assistance
  • Monitoring Dashboard & Email AlertsMonitoring Dashboard & Email Alerts
  • Changes & Cancellations included at no chargeChanges & Cancellations included at no charge
  • Free Plan

  • $0

    per month

  • Number of included transactions

    10
  • Average price per transaction0 cents
  • Counts as transactionseManifest, ISF, PTT, SNP,
    Type 86, FSN, Manifest Query
  • CBP Responses included at no charge
  • 24/7 Support
  • On-Boarding Assistance
  • Monitoring Dashboard & Email Alerts
  • Changes & Cancellations included at no charge
  • Grow

  • $49

    per month

  • Number of included transactions

    200
  • Average price per transaction25 cents
  • Counts as transactionseManifest, ISF, PTT, SNP,
    Type 86, FSN, Manifest Query
  • CBP Responses included at no charge
  • 24/7 Support
  • On-Boarding Assistance
  • Monitoring Dashboard & Email Alerts
  • Changes & Cancellations included at no charge
  • Express

  • $99

    per month

  • Number of included transactions

    650
  • Average price per transaction15 cents
  • Counts as transactionseManifest, ISF, PTT, SNP,
    Type 86, FSN, Manifest Query
  • CBP Responses included at no charge
  • 24/7 Support
  • On-Boarding Assistance
  • Monitoring Dashboard & Email Alerts
  • Changes & Cancellations included at no charge
  • Scale

  • $299

    per month

  • Number of included transactions

    3000
  • Average price per transaction10 cents
  • Counts as transactionseManifest, ISF, PTT, SNP,
    Type 86, FSN, Manifest Query
  • CBP Responses included at no charge
  • 24/7 Support
  • On-Boarding Assistance
  • Monitoring Dashboard & Email Alerts
  • Changes & Cancellations included at no charge
Click here to expand!Click here to collapse!
  • Select your plan

  • Number of included transactionsNumber of included transactions
  • Average price per transactionAverage price per transaction
  • Counts as transactionsCounts as transactions
  • CBP Responses included at no chargeCBP Responses included at no charge
  • 24/7 Support24/7 Support
  • On-Boarding AssistanceOn-Boarding Assistance
  • Monitoring Dashboard & Email AlertsMonitoring Dashboard & Email Alerts
  • Changes & Cancellations included at no chargeChanges & Cancellations included at no charge
  • Consolidator

  • $499

    per month

  • Number of included transactions10,000
  • Average price per transaction5 cents
  • Counts as transactionseManifest, ISF, PTT, SNP,
    Type 86, FSN, Manifest Query
  • CBP Responses included at no charge
  • 24/7 Support
  • On-Boarding Assistance
  • Monitoring Dashboard & Email Alerts
  • Changes & Cancellations included at no charge
  • Business

  • $999

    per month

  • Number of included transactions25,000
  • Average price per transaction4 cents
  • Counts as transactionseManifest, ISF, PTT, SNP,
    Type 86, FSN, Manifest Query
  • CBP Responses included at no charge
  • 24/7 Support
  • On-Boarding Assistance
  • Monitoring Dashboard & Email Alerts
  • Changes & Cancellations included at no charge
  • Enterprise

  • $1499

    per month

  • Number of included transactions50,000
  • Average price per transaction3 cents
  • Counts as transactionseManifest, ISF, PTT, SNP,
    Type 86, FSN, Manifest Query
  • CBP Responses included at no charge
  • 24/7 Support
  • On-Boarding Assistance
  • Monitoring Dashboard & Email Alerts
  • Changes & Cancellations included at no charge
  • eCommerce

  • $1999

    per month

  • Number of included transactions100,000
  • Average price per transaction2 cents
  • Counts as transactionseManifest, ISF, PTT, SNP,
    Type 86, FSN, Manifest Query
  • CBP Responses included at no charge
  • 24/7 Support
  • On-Boarding Assistance
  • Monitoring Dashboard & Email Alerts
  • Changes & Cancellations included at no charge
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