What is the FDA Prior Notice?
To fulfill the provisions of the Bioterrorism Act, the Food and Drug Administration (FDA) issued a final regulation that requires advance notice to be given for all incoming shipments of imported food into the United States.
Since May 6, 2009, the FDA has required food importers in the United States to submit a Prior Notice of any imports of human food and animal food imported into the United States, unless the particular food has been exempted from such provisions.
Why is Prior Notice Required
By giving Prior Notice of any imported animal food or foods for human consumption, the FDA will have time to:
- Evaluate and review the information before the food arrives in the United States
- Effectively deploy resources and conduct inspections on shipments
- Intercept any contaminated shipments
What Industries are Affected by the New Regulations
Any industry sectors that import, transport, or export food through or into the United States are impacted by the prior notice regulations. Some industry sectors impacted include:
- Foreign and domestic cross-border transporters using air, rail, ship, and truck transport
- Foreign and domestic importers
- Foreign and domestic exporters
- Foreign and domestic brokers and filers
- Foreign and domestic growers and manufacturers
What is Defined as Food Under Prior Notice
Under the new regulations, food is defined as
- Articles that may be used as drink or food by man or other animals
- Chewing gum
- Articles used in the manufacturer of food items and chewing gum
What Food Items Require Prior Notice
All food imports that are subject to regulation require Prior Notice, even though certain exemptions may apply. Food imports requiring prior notice include
- Foods imported for distribution, storage, or use in the United States; may include trade and gifts, food for quality control/quality assurance, and market research samples.
- Food on transit across the United States destined for another country.
- Food imported for export or food intended to be used in Foreign Trade Zone unless exemptions apply.
Some of the exemptions that may apply include:
- Food brought into the United States for a person’s use that may include consumption by themselves, friends, or family and not for distribution or sale
- Food made by a person in their residence and sent to the US for nonbusiness reasons that may include a gift for a person in the United States
- Food exported outside the US that will not leave the port of arrival until it is exported
- Egg products, poultry products, or meat food products which when imported are under the exclusive jurisdiction of the USDA under the Egg Products Inspection Act, the Poultry Products Inspection Act, and the Federal Meat Inspection Act.
- Food in diplomatic pouches/bags is exempted under the Diplomatic Relations of The Vienna Convention.
Who Can Give Prior Notice
Any person including US agents, individuals, importers, manufacturers, brokers, and exporters may submit the required prior notice information.
If food is imported and there is no adequate Prior Notice given, the shipment may be refused entry at the port. Under the FDA regulations, FDA staff may impose injunctions, hold, refusals, debarment, and prosecution depending on the severity of the failure to provide proper and timely Prior Notice in compliance with the Prior Notice regulations of the FDA.
Prior Notice has to be submitted electronically through the Prior Notice System Interface (PNSI) of the FDA or the Automated Commercial Environment (ACE) or the Automated Broker Interface (ABI) System of the Customs and Border Protection agency (CBP).
When to Give Prior Notice
The FDA must receive the electronic Prior Notice before the arrival of the food shipment at the American port of entry. It is important to note that the mode of transport will determine the deadline for submitting the Prior Notice.
Overall, FDA needs to get and confirm the receipt of the Prior Notice no more than 30 days before the arrival of a shipment if the submission is through either ACS or ABI. When submitting through the PNSI portal, The Prior Notice has to be received no more than 15 days before the arrival of the food shipment.
Specific FDA PN deadlines for submission by mode of transport:
- Shipments arriving via road have to have the FDA PN filed at least two hours before arrival at the port of entry.
- Shipments arriving via rail or air need to have FDA PN filed at least four hours before arrival at the port of entry.
- Shipments arriving by water need to have FDA PN filed no less than eight hours before arrival at the port of entry.
- Shipments arriving via international mail will need to have FDA PN submitted before the food is sent.
- Shipments belonging to or otherwise accompanying persons will have to have their notices submitted according to the time frame of the mode of transport.
What Information is Required for Prior Notice
Brokers or importers already provide much of the information needed for Prior Notice through other documentation provided to the CBP upon the importation of food products. Still, some of the information that they will have to provide under these new regulations include:
- Name, email, telephone number, and business address of the person submitting the Prior Notice in addition to the company address and name if applicable
- Name, company name, email, telephone number, and business address of the person transmitting the Prior Notice if the person doing so is doing it on behalf of someone else
- CBP identifier if available and the entry type
- Identification of each article in the shipment by estimated quantity, common market name or product name, FDA product code, code or lot number, or any other identifier
- If it is a manufactured or processed food – the manufacturer’s name, country, city, registration number, and address
- For foods in their natural state, the growing location, and the name of the grower if it is known
- FDA country of production
- Shipper’s full address and name
- Country from which the shipment has been exported or if sent by international mail, the country from which the shipment was mailed, and the anticipated date of export.
- Arrival information, which includes anticipated time, date, and location, and in case of international mail, the recipient’s name and address in the US.
- Full name and address of the consignee, owner, and importer unless the food shipment is offered for import or is imported for transshipment across the United States under a transportation and exportation entry. In the instance of importation via international mail the address of the American recipient and their address
- Mode of transportation and carrier except for shipments by international mail
- Planned shipment information except for international mail shipments
- Countries to which the article was being imported were denied entry
Prior Notice Confirmation Number & Envelope Number
After submitting the FDA PN and the data is accepted by the FDA, you will receive a PNC # (Prior Notice Confirmation Number). The PNC # is your proof of FDA acceptance. The PNC # can be referenced on the box that you are shipping to the USA.
An envelope number is a confirmation number for the passing of the FDA PN message between CBP & FDA.
After getting your FDA PN accepted you may print a summary document showing the details included in the FDA PN submission along with the envelope and PNC #.
Getting Help on Prior Notice Submission
Exporters, brokers, and individuals can get help on the submission of Prior Notices by contacting CustomsCity Global Solutions Inc. CustomsCity provide an option to manually enter the FDA PN into a web-based portal. There is also an upload option to easily create thousands of FDA PN at one time. Affordable monthly price plan options are available by clicking here.
Frequently Asked Questions
FDA Prior Notice (including prior notice FDA and US FDA prior notice) is a requirement by the U.S. Food and Drug Administration for certain regulated products, such as food, cosmetics, and supplements, entering the United States. It helps the FDA review shipments before arrival, enhancing safety and compliance while reducing holds and refusals.
For CBP ecommerce and D2C ecommerce shipments, FDA prior notice must still be submitted if the products fall under FDA regulation. Even for low-value parcels sold direct to consumer, failure to provide accurate US FDA prior notice can lead to delays or rejection at the border.
The US FDA prior notice must be submitted to the FDA before the cargo arrives at the port or border crossing. This includes D2C and B2B shipments with regulated goods, and it should be completed accurately and on time to avoid holds or penalties.
Yes — modern customs clearance software solutions can automate FDA prior notice filings and compliance checks. This reduces manual entry, improves accuracy for prior notice FDA submissions, and helps ecommerce and logistics teams stay compliant without slowing down shipment timelines.
