Every food, beverage or supplement shipment to the U.S. needs a Prior Notice before it arrives. Send us the shipment details. We file it with FDA and email you the Prior Notice Confirmation Number for your courier, broker or parcel.
Quick answer: FDA Prior Notice is required for every shipment of food entering the United States, including samples and courier parcels. It must be confirmed by FDA at least 2 hours (road), 4 hours (air or rail) or 8 hours (sea) before arrival. For international mail, it must be filed before the parcel is sent. Without it, the shipment is refused and held at the port.
FDA counts the time from when it confirms the Prior Notice, not from when you start the filing. File as soon as the shipping details are fixed.
| How the food arrives | File at least | File no earlier than |
|---|---|---|
| 🚢 Sea freight | 8 hours before arrival | 15 days before arrival (FDA Prior Notice System) 30 days if filed through the customs entry (ACE) |
| ✈️ Air freight & express courier | 4 hours before arrival | |
| 🚚 Road / 🚆 rail | 2 hours (road) · 4 hours (rail) | |
| 📮 International mail | Before the parcel is sent. The confirmation number must go with the parcel. | |
Source: 21 CFR 1.279.
Use the form below or email us the invoice, packing list or airway bill.
Correct FDA product code, the manufacturer's FDA registration, and the arrival port and time.
Submitted in FDA's Prior Notice system for each product in the shipment.
We email the Prior Notice Confirmation Number. Give it to your courier or broker, or attach it to the parcel.
⚠️ The most common reason for a hold: the manufacturer's FDA food facility registration is missing or expired. Food facility registrations expire on December 31 of every even year. If your manufacturer is not registered, we can register it — $300 including U.S. Agent.
If you ship food or supplements to the U.S. often (for example to Amazon FBA) and have no U.S. company, you also need an FSVP importer named on each entry.
Pay online now, or send the details first. We confirm by email before filing.
Fill in what you know. We reply by email to confirm anything missing, then file.
You can also email the commercial invoice and packing list to info@orionexregulatory.com.
Prior Notice is an advance notice to FDA about a food shipment coming into the United States. It is required for food, beverages, dietary supplements, food ingredients and animal food under the Bioterrorism Act (21 CFR Part 1, Subpart I). FDA uses it to decide whether to inspect the shipment when it arrives.
FDA must confirm it at least 2 hours before arrival by road, 4 hours by air or rail, and 8 hours by sea. It can be filed up to 15 days before arrival in FDA's Prior Notice System Interface. For international mail, it must be filed before the parcel is sent.
No. Registration is for the manufacturing facility and is renewed every two years. Prior Notice is filed for each shipment. The manufacturer's registration number is part of the Prior Notice, so an unregistered or expired facility causes the shipment to be held.
Yes. Commercial samples, trade-show goods and food sent by a business by courier or mail all need Prior Notice. The main exemptions are food carried in a traveller's own baggage for personal use, homemade food sent by one person to another as a non-business gift, and meat, poultry and egg products regulated only by USDA.
Food arriving without valid Prior Notice is refused and held at the port or in a secure facility until it is fixed or exported. Storage and demurrage costs fall on the shipper or importer.
Some brokers and couriers file Prior Notice as part of the customs entry, often for an extra fee. Others will not accept food unless you already have a Prior Notice Confirmation Number. For international mail, the confirmation number must travel with the parcel.
Work begins within one business day of receiving complete shipment details. For a shipment leaving soon, choose 'Urgent' on the form and send the details as early as you can.
Send the details now. We file and email you the confirmation number.