KGP FDA
Free Preliminary Assessment

FDA – Food and Dietary Supplements

Prior Notice

Fee: $125 / shipment (Mention customs clearance and IOR needs in the form)

Prior Notice must be submitted to FDA for human and animal food entering the United States, including samples and gifts. The notice must be submitted before the food arrives at the port of arrival: no less than 2 hours before arrival by land, 4 hours by rail or air, and 8 hours by sea.

Who Is Obligated?

Every shipment of food to the United States. There are exceptions, such as meat, poultry and egg products under USDA jurisdiction and food carried by a traveler for personal use. Food with no prior notice, or with an inaccurate or late notice, is held at the port and may be refused entry.

What We Do

  • We submit the Prior Notice for each shipment.
  • We send the confirmation number to you and your importer.
  • We check the shipment details before submitting the notice.

What You Receive

  • Prior Notice confirmation number
  • Summary of the information used in the notice

Prior Notice Application

Shipment, party, and product details so that we can file Prior Notice with the FDA for a food shipment bound for the United States.

  1. 1 Shipment
  2. 2 Parties
  3. 3 Products
  4. 4 Submit
1. Shipment
Mode of transport *

Your details are used only to prepare your application. An unfinished application is kept in this tab.

Frequently Asked Questions

I am sending samples or gifts. Do I still need to file a notice?
Yes. Prior Notice is required for human and animal food entering the United States, including samples and gifts.
How far in advance must the notice be submitted?
Before the food arrives at the port of arrival: no less than 2 hours before arrival by land, 4 hours by rail or air, and 8 hours by sea. You only need to send us the shipment details before then.
What happens if no notice is submitted?
Food with no prior notice, or with an inaccurate or late notice, is held at the port and may be refused entry.
Does Prior Notice also require facility registration?
The notice requires the FDA registration number of the facility that manufactured the food. If your facility is not registered, facility registration must be completed first.

Sources: 21 CFR 1.277; 21 CFR 1.279; 21 CFR 1.281; 21 CFR 1.283.