The difference at a glance
| Food facility registration | Prior Notice | |
|---|---|---|
| What it covers | A facility that makes, packs or stores food | One food shipment coming into the U.S. |
| How often | Once, then renewed every two years (October to December of even years) | Every shipment, before it arrives |
| Who usually files | The facility, or its U.S. Agent or consultant | The importer, customs broker or shipper |
| What happens without it | Shipments from the facility can be held at the port | The shipment can be refused or held at the port |
How they connect
A Prior Notice must include the FDA registration number of the facility that made the food. If the facility is not registered, or the number is wrong, the Prior Notice is not correct and the shipment can be held. So registration comes first.
When Prior Notice must be filed
Prior Notice must reach FDA before the food arrives. The minimum times depend on how the food travels:
- 2 hours before arrival by road
- 4 hours before arrival by air or rail
- 8 hours before arrival by water
- Before the package is sent, for international mail
After filing, FDA gives a Prior Notice confirmation number, which must travel with the shipment.
Questions
I have a registration number. Do I still need Prior Notice?
Yes. Registration covers the facility. Prior Notice is still needed for every shipment.
Do samples and online orders need Prior Notice?
Yes, food shipped to the U.S. generally needs Prior Notice, including commercial samples and parcels sent to customers. There are only narrow exceptions, such as food carried by travelers for personal use.
Can Regovant file Prior Notice for us?
Yes. We file Prior Notice for $25 per shipment and send you the confirmation number.
How Regovant can help
Regovant LLC registers food, cosmetic, device and drug facilities with FDA, checks your D-U-N-S details and acts as your U.S. Agent. Food facility registration with U.S. Agent service is $269 per year. See all guides or services and prices.