What Is FDA Prior Notice
FDA Prior Notice is a mandatory requirement issued by the U.S. Food and Drug Administration (FDA) for any food, beverage, or dietary product entering the United States for human or animal consumption. It allows both the FDA and U.S. Customs and Border Protection (CBP) to review shipment details before arrival. If Prior Notice is not filed or is filed incorrectly, the shipment may be refused entry, detained, or destroyed.
When Is Prior Notice Required
Prior Notice must be filed for any imported food item that meets all of the following conditions:
It is entering the United States, regardless of shipping method
It is intended for human or animal consumption
It falls under FDA jurisdiction rather than USDA
Even small shipments, promotional samples, or personal gifts require Prior Notice if they contain food, beverages, or dietary products.
Timing requirements:
Submit Prior Notice at least 2 hours before arrival at the border for ground transport
Submit Prior Notice at least 4 hours before arrival for air shipments
Common Examples of Products That Require Prior Notice
Packaged or prepared foods such as snacks, sauces, soups, and candies
Beverages including juices, teas, soft drinks, and energy drinks
Dietary supplements and vitamins
Pet food, treats, and animal nutritional products
Spices, condiments, and baking ingredients
Ready to eat, frozen, dehydrated, or shelf stable meals
Regulatory Requirements for Pet Food and Treats
Pet food and animal feed products are regulated by the FDA Center for Veterinary Medicine and require Prior Notice under the same rules that apply to human food imports.
This includes:
Dry, wet, frozen, or dehydrated pet food
Pet treats, chews, biscuits, and snacks
Nutritional supplements or vitamins for pets or livestock
Animal feed and meal based products
Even if sent as samples or gifts, these items still require Prior Notice.
Best Practices for Pet Food Descriptions
Use clear descriptions on your commercial invoice, such as:
Dehydrated beef liver pet treats for animal consumption
Dry dog food chicken and rice formula, 2 kg bag
Clear descriptions help the FDA identify the product quickly and reduce delays.
Products That Do Not Require Prior Notice
The following products do not require FDA Prior Notice, although some may still be regulated under different authorities:
Non food items such as cosmetics, apparel, electronics
Pharmaceuticals regulated by other FDA divisions
Food produced in the United States and returning without modification
In transit shipments that do not enter U.S. commerce
USDA regulated items, including meat, poultry, and certain egg products
Where and How to File FDA Prior Notice
Prior Notice can be filed directly through the FDA Prior Notice System Interface (PNSI):
https://www.access.fda.gov/
This online system allows shippers or importers to submit Prior Notice without using a broker. After filing, you will receive a Prior Notice Confirmation Number (PNCN), which must be:
Provided to the carrier, or
Included on the commercial invoice in the International Details section
Attach a printed copy of the PNCN to the shipment whenever possible.
Is a Tracking Number Required
A tracking number is not required at the time of filing, since it may not yet be available.
If you have it, include it to assist with matching the Prior Notice to the physical shipment.
Exception
For international mail shipments (postal service), the FDA requires the mail service name and tracking number on the Prior Notice submission.
Regardless of carrier, the PNCN must be given to the courier before export, and a printed copy should travel with the shipment.
Information Required to File Prior Notice
When filing through the FDA PNSI, have the following details ready:
Complete product description, such as roasted coffee beans 250 g vacuum pack
Manufacturer name and address
Shipper and importer details
Country of production and shipment
Quantity, packaging type, and declared value
Tracking number if available
Estimated date and port of arrival into the United States
Why Prior Notice Matters
Filing Prior Notice ensures:
Faster customs clearance
Fewer inspection related delays
Compliance with FDA import regulations
Avoidance of shipment refusal or destruction
Prevention of fines or penalties
If the FDA cannot locate a valid Prior Notice before the shipment arrives, the goods may be detained or refused.
Who Is Responsible for Filing
The shipper or exporter is responsible for ensuring that FDA Prior Notice is submitted correctly and on time.
Summary Table
| Requirement | Applies To | Filed By | Tracking # Needed? | Consequence if Missing |
|---|---|---|---|---|
| FDA Prior Notice | All food, beverage, dietary, and pet-food products for human or animal consumption entering the U.S. | Shipper or exporter | Optional (required for international mail) | Delay, return, or destruction by FDA/CBP |
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