FDA & Food
FDA prior notice for imported food: requirements and deadlines
Who files FDA prior notice, the deadline for each mode of transport, what the PN confirmation number is, and what happens to food that arrives without it.
October 1, 2026: new data for food sent by international mail
From October 1, 2026, a prior notice for food sent by international mail must also give the name of the mail service and the mail tracking number (21 CFR 1.281(b)(10)).
FDA prior notice is advance information about imported food that the Food and Drug Administration must confirm before the food arrives in the United States. It comes from the Bioterrorism Act of 2002, which added section 801(m) to the Federal Food, Drug, and Cosmetic Act. The rules are in 21 CFR 1.276 to 1.285.
FDA uses the notice to decide, before arrival, if it will inspect the food. Food without adequate prior notice is refused and stays at the port. It is not delivered to the importer.
Which food needs FDA prior notice?
All food for humans and animals that is imported or offered for import (21 CFR 1.277(a)). This includes gifts, trade and quality control samples, food in transit to another country, food for later export and food for a foreign trade zone.
Food has a wide meaning: fruits, vegetables, seafood, dairy, eggs, animal feed and pet food, ingredients and additives, dietary supplements, infant formula, beverages (including alcohol and bottled water), live food animals, snacks, candy and canned foods (21 CFR 1.276(b)(5)). Food contact substances and pesticides are not included. Food from a farm that does not register with FDA still needs prior notice.
What food is exempt from prior notice?
21 CFR 1.277(b) lists seven exclusions:
- Food for personal use that a person carries, or that travels with the person, on arrival.
- Food that a person made at home and sends as a personal gift (not for business) to a person in the United States.
- Food that is imported and then exported without leaving the port of arrival.
- Meat food products under the exclusive jurisdiction of USDA.
- Poultry products under the exclusive jurisdiction of USDA.
- Egg products under the exclusive jurisdiction of USDA.
- Food in a diplomatic bag (Vienna Convention, Article 27(3)).
Trade samples in your luggage are not exempt, because they are for business use.
What are the FDA prior notice deadlines?
FDA must confirm the notice a set time before the food reaches the port of arrival (21 CFR 1.279). The clock starts when FDA confirms the notice, not when you send it.
| Mode of transport | FDA confirmation no later than |
|---|---|
| Land by road (truck, bus, car) | 2 hours before arrival |
| Land by rail | 4 hours before arrival |
| Air (including express couriers) | 4 hours before arrival |
| Water | 8 hours before arrival |
| International mail | Before the food is sent to the United States |
The port of arrival is the first U.S. port: the port of unloading for water and air, and the border crossing for land (21 CFR 1.276(b)(11)). It can differ from the port where the entry is filed, for example when the food moves in-bond to an inland port.
Who can submit prior notice?
Any person with knowledge of the required information (21 CFR 1.278). That person is the submitter. Another person, for example a customs broker, can send the data as the transmitter. The data must be in English and in Latin letters (21 CFR 1.280(a)).
ACE or the Prior Notice System Interface (PNSI)?
There are two electronic routes to FDA (21 CFR 1.280). Both are open 24 hours a day, 7 days a week.
| ACE (through ABI) | FDA PNSI | |
|---|---|---|
| Who can use it | Brokers and self-filers that CBP authorizes for ABI | Anyone with an account at access.fda.gov |
| Filed with | The CBP entry, an in-bond, or as a stand-alone notice | Separately, on the FDA website |
| Earliest submission | 30 calendar days before arrival | 15 calendar days before arrival |
| Typical use | Commercial shipments that a broker enters | Mail, in-bonds, foreign trade zones, and when ABI is down |
If the broker's system or ABI does not work, the notice must go through PNSI (21 CFR 1.280(b)). The earliest-submission limits do not apply to international mail.
What is the PN confirmation number, and what must travel with the goods?
When FDA confirms a notice for review, it replies with a Prior Notice (PN) confirmation number (21 CFR 1.279(d)). Each article of food needs its own notice and number. The number must travel with the food in these cases:
- International mail: on the customs declaration (CN22, CN23 or the U.S. equivalent) (21 CFR 1.279(e)).
- Filed in PNSI: with the food, for CBP or FDA on arrival (21 CFR 1.279(g)).
- Carried by a traveler, not for personal use: a copy of the confirmation, for CBP or FDA on arrival (21 CFR 1.279(f)).
When a broker files in ACE with the entry, FDA sends the number to the broker in ACE.
How does prior notice work for mail and courier shipments?
International mail means a foreign postal service. Express couriers are not international mail, unless they work as the agent of a foreign postal service (21 CFR 1.276(b)(8)).
International mail
The notice must be confirmed before the parcel is mailed, with the number on the CN22 or CN23. It gives the U.S. recipient and the date of mailing, and from October 1, 2026 the mail service and tracking number. If the notice is inadequate or the number is missing, CBP holds the parcel for 72 hours for FDA. FDA can return the refused parcel to the sender, or destroy it if there is no return address (21 CFR 1.283(e)). For other mail holds, see detained mail and CBP Form 3509.
From October 22, 2026, mail of $2,500 or less with FDA requirements needs formal entry or entry type 13. CBP also updated the draft ACE guide for stand-alone prior notice for entry type 13.
Express couriers
Food by FedEx, UPS or DHL follows the deadline for its mode: 4 hours by air, 2 hours by road. The courier tracking number can replace the arrival details and the air waybill number (21 CFR 1.281(a)). See courier-held parcels if a courier holds your food.
What information does prior notice require?
21 CFR 1.281(a) lists the data. The main items are:
- The submitter and transmitter, the entry type and the CBP entry or in-bond number.
- The FDA product code, the common name, the quantity and, where FDA requires them, lot codes.
- For processed food, the manufacturer and its FDA registration number. For fresh food, the grower, if known.
- The FDA country of production, the shipper and the country of shipment.
- The port, date and time of arrival, the carrier and the shipment numbers (bill of lading, flight, container).
- The importer, owner and ultimate consignee, and any country that refused the food.
Food from a foreign facility that must register and is not registered is held under 21 CFR 1.285. See FDA food facility registration, and renew by December 31, 2026.
What happens if prior notice is missing, late or inaccurate?
The food is subject to refusal of admission under section 801(m)(1) (21 CFR 1.283). A late notice is not refused if FDA already reviewed it and told CBP its decision. Refused food:
- Stays in the port of entry, or a secure facility that FDA knows of, as general order merchandise.
- Moves only under a custodial bond and is not delivered to the importer, owner or consignee.
- Can be exported with CBP concurrence. FDA and CBP do not pay storage or transport.
If the notice was missing or inaccurate and the food stays, submit a correct notice within 10 calendar days of the refusal. To dispute the refusal, ask FDA for review within 5 calendar days. Otherwise the food can only be sold for export or destroyed, unless CBP and FDA agree otherwise. See FDA holds and detentions.
FDA and CBP: who does what?
FDA receives and confirms the notice and decides if the food needs an inspection. CBP controls the cargo at the port, holds refused food and handles the entry and duties. A release under the prior notice rule is not an FDA admission decision (21 CFR 1.283(g)).
FSVP: your ongoing obligation
Beyond prior notice, the Foreign Supplier Verification Program (FSVP) requires importers to verify that their foreign suppliers produce food that meets US safety standards. This is an ongoing compliance obligation, not just a one-time filing. Your customs broker can help you understand your FSVP requirements.
Questions
Does food that I order online for personal use need prior notice?
Yes. The personal use exclusion applies only to food that you carry or that travels with you when you arrive. Food shipped to you by mail or courier needs prior notice. For mail, the seller is the practical filer, because the confirmation number must be on the CN22 or CN23.
Does FDA charge a fee for prior notice?
No. FDA does not charge a fee to file prior notice or to use PNSI. A customs broker that files prior notice through ACE can charge for that service. Ask your broker if prior notice is part of the entry price or a separate line.
Does a PN confirmation number mean that FDA released my food?
No. The number shows only that FDA received the prior notice for review. FDA can still hold the food for an examination or a sample. The food must also meet all other FDA rules, for example labeling, facility registration and FSVP.
Can one prior notice cover repeat shipments of the same product?
No. Each article of food in each shipment needs its own prior notice and gets its own confirmation number. A notice also cannot be filed more than 30 days (ACE) or 15 days (PNSI) before arrival, so a standing notice for many shipments is not possible.
What if the arrival time or quantity changes after FDA confirms the notice?
Changes to the quantity, the arrival details or the shipment numbers do not need a new notice. Other changes do, for example a different product, manufacturer or shipper. Cancel the old notice in PNSI, or ask CBP to cancel the entry if it was filed in ACE (21 CFR 1.282).
Are homemade gifts and bought gifts treated the same?
No. Food that a person made at home and sends as a personal gift is excluded. Food bought in a store and sent as a gift needs prior notice. FDA has an enforcement policy for bought gifts that an individual sends for non-business purposes, but the rule still applies.
Who files prior notice when Allied is our customs broker?
Allied files prior notice through ACE with the entry data. Before the shipment leaves, send us the product, the manufacturer and its FDA registration number, the shipper and the arrival details. For mail, the foreign shipper is the practical filer, because the number must be on the parcel before it is sent.
60% of our business is FDA/agricultural
Send us the product, the manufacturer and the arrival details before the shipment leaves. We file prior notice through ACE with the entry.
Sources
- 21 CFR 1.276: definitions
- 21 CFR 1.277: scope and exclusions
- 21 CFR 1.278: who may submit
- 21 CFR 1.279: deadlines and PN confirmation number
- 21 CFR 1.280: ACE and PNSI
- 21 CFR 1.281: required information
- 21 CFR 1.282: changes after confirmation
- 21 CFR 1.283: refusal and hold
- 21 CFR 1.285: food from unregistered facilities
- Federal Register, September 25, 2025: mail tracking number final rule
- FDA: Prior Notice of Imported Food Questions and Answers (Edition 4)
- FDA: Filing Prior Notice of Imported Foods