FDA Prior Notice is a notification submitted to the FDA for every food shipment entering the United States before the shipment reaches its port of entry. It is distinct from facility registration: registration is a notification that must be renewed every two years, whereas Prior Notice is filed separately for each shipment. When the notification is approved, the FDA issues a PN Confirmation Number, and the notification period begins with this number.
The timeframes vary depending on the mode of transport and are defined in hours: 2 hours for road transport, 4 hours for rail and air transport, and 8 hours for sea transport. There is also an upper limit: sending the notification too early is not permitted. For international mail, however, the rule works quite differently—the notification must be sent before the goods are dispatched.
Below, we discuss who is responsible for filing the notification, the timeline, the rules that will change at the end of 2025, and the procedure to follow if a notification is missing.
What is FDA Prior Notice, and who submits it?
Prior Notice is the advance notification to the FDA of food imported into or presented for import into the United States. Its purpose is to allow the inspection authority at the port of entry to plan for the shipment’s arrival before it arrives. The notice is typically submitted by the importer or a customs broker acting on the importer’s behalf; the manufacturer is not required to submit it directly.
There are two submission channels: the FDA’s own interface, PNSI, and the customs-side channels ABI, ACE, and ITDS. The channel used for submission also determines how far in advance the notification can be submitted.
The manufacturer’s role here is indirect but crucial. The notification requires the facility registration number, as well as information about the manufacturer and the shipper. Since this information comes from the facility, the notification may be incomplete if the registration number is not up to date. We’ve addressed situations where the registration status is compromised in our article on FDA registration revocation and re-registration.
How long are the prior notice periods?
21 CFR 1.279 specifies different time frames depending on the mode of transportation. The notification must be submitted at least this long before the goods arrive at the point of entry. In addition, the earliest the notification can be submitted is limited depending on the channel.
| Transport mode | What is the latest time? | Reference |
|---|---|---|
| Highway | 2 hours before arrival | 21 CFR 1.279 |
| Railroad | 4 hours before arrival | 21 CFR 1.279 |
| Airline | 4 hours before arrival | 21 CFR 1.279 |
| Maritime | 8 hours before arrival | 21 CFR 1.279 |
| International mail | Before the goods are shipped to the U.S. | 21 CFR 1.279 |
| Delivery channel | When is the earliest |
|---|---|
| FDA PNSI | No more than 15 calendar days before the expected arrival date |
| ABI, ACE, ITDS | No more than 30 calendar days before the expected arrival date |
Since most shipments from Turkey to the U.S. are sent by sea, in practice, an 8-hour timeframe and a 30-day upper limit are typically discussed. If the estimated arrival time on the ocean bill of lading changes, the notification must be adjusted accordingly.
When is a notice considered to have been submitted?
When the FDA accepts a submission for review, it sends a confirmation message that includes a PN Confirmation Number. The submission is considered filed as soon as the FDA approves it for review, and the timeline begins at that point. In other words, the date of approval—not the date of submission—is the determining factor.
How do the rules apply to food sent by mail?
For food items sent via international mail, there is a different rule than the time-based deadline: the notification must be made before the goods are shipped to the U.S. Additionally, the PN Confirmation Number must appear on the customs declaration (CN22, CN23, or the equivalent in the U.S.) that accompanies the package.
This issue often comes up in connection with sample and first-batch shipments. Sending the sample via courier and then filing the notification reverses the order required by the regulation.
A regulation published in the Federal Register on September 25, 2025 (90 FR 46045) added another field here. Effective October 1, 2026, the name of the shipping company and the tracking number are required when declaring food sent via international mail. This date coincides with the opening of the 2026 registration renewal window; details can be found in our FDA registration renewal guide.
Bu madde yalnızca uluslararası posta ile giden gıdayı kapsıyor: numune, küçük parti ve e-ticaret paketleri. Konteynerle ya da hava kargosuyla giden ticari yüklerin bildirimi değişmiyor, onlar yukarıdaki saat esaslı sürelerle devam ediyor. Kural yeni de değil, 25 Eylül 2025’te yayımlanmıştı; 1 Ekim 2026 yürürlük tarihi. Postayla numune yollayan bir ihracatçı için pratik karşılığı şu: takip numarası bildirim yapılmadan önce elde olmalı, yani kargo kaydı bildirimden önce açılıyor.
What information is required in the Prior Notice?
The declaration contains a set of information identifying the shipment. It includes the product description and quantity, the manufacturer’s and shipper’s information, the facility registration number, the country of origin of the goods, the carrier, and the expected destination and date of arrival. The sender’s own information is also recorded.
Most of these fields are populated based on documents provided by the manufacturer. When the information on the invoice, packing list, and bill of lading does not match, a discrepancy may also arise on the declaration side. Therefore, having the set of documents verified by a single point of contact before shipment eliminates the need to treat the declaration as a separate task.
If a shipment contains more than one product, a notification is issued for each item. The most common issue with mixed loads is that an item may be overlooked. While this may only affect that specific item—rather than the entire load—in practice, it can result in the entire shipment being delayed.
What happens if a notification is missing?
Food imported or presented for import without adequate prior notice may be refused entry under Section 801(m)(1) of the Act. If the refused goods are not immediately exported under customs supervision, they are held under appropriate bond. The location at the port where the goods will be held must be reported to the FDA before the goods are moved there.
A notification may be submitted at a later date, or an FDA review may be requested. If neither of these actions is taken and the export does not take place, the goods are handled in accordance with the general provisions of customs regulations and, unless the parties agree otherwise, may only be sold for export or destroyed.
The process is slightly different for international mail. If the declaration is incomplete or the confirmation number has not been included as required, the package is held by customs for 72 hours pending FDA review and a decision. If the FDA rejects the shipment under Section 801(m)(1) and a return address is provided, the package may be returned to the sender with a note indicating that it was rejected.
| Status | Duration | Source |
|---|---|---|
| Submission of Prior Notice Following a Rejected or Held Shipment | 10 days | 90 FR 46045, effective October 27, 2025 |
| Submission of Facility Registration for a Shipment Held Due to an Unregistered Facility | 30 calendar days | 90 FR 46045, effective October 27, 2025 |
| Customs detention period if the declaration on a package received by mail is insufficient | 72 hours | 21 CFR 1.283 |
These time limits are at the heart of the changes coming at the end of 2025. Previously, there was no defined maximum time limit for post-refusal and post-hold submissions; now there is. Considering the cost of pending shipments, it makes more sense to act early rather than wait until the very end.
What do I need to do to keep the notification secure?
Most of the information in the declaration comes from the manufacturer, so that’s where some of the errors originate. When the following four items are included as standard components of the information package sent to the customs broker, friction on the declaration side is reduced.
| Pencil | Why is it important? |
|---|---|
| Current facility registration number | As stated in the notice, if the registration has not been renewed, the number may no longer be valid |
| The manufacturer and shipper information must match the information on the documents | The difference between a declaration and a notification can raise additional questions |
| Accurate product description and quantity | The content of the statement must correspond to the actual action |
| Notification of a Change in the Estimated Time of Arrival | The time limits are based on the arrival time |
The U.S. Agent is not required to submit this notification, but questions directed by the FDA to the facility may be relayed through the agent. The agent’s role and the verification process are detailed in our FDA U.S. Agent Guide. For the procedure to follow when an inspection begins at the point of entry, please refer to our Import Refusal Guide.
Frequently Asked Questions
Should the manufacturer send the Prior Notice?
It is not mandatory. The notification is typically submitted by the importer in the U.S. or the importer’s customs broker. The manufacturer is responsible for providing accurate and up-to-date facility and product information as required in the notification.
Are "Prior Notice" and "facility registration" the same thing?
No. The facility registration is a notification that is renewed every two years, while Prior Notice is filed separately for each shipment. The facility registration number is required for the Prior Notice filing; in other words, the two are linked but are not the same process.
The notification has been approved—does this mean FDA approval?
No. The PN Confirmation Number is a number indicating that the notification is under review. The FDA does not approve food facilities or shipments; the decision at the point of entry is handled as a separate process.
If my arrival date changes, do I need to resubmit the notification?
Since the timeframes are based on the estimated arrival time, any change in the estimated arrival time must be reflected in the declaration. In practice, this is handled by the customs broker, but it is the shipper’s responsibility to notify the broker of the change in a timely manner.
Is prior notice also required when sending a sample?
Food shipments intended for purposes other than personal use are subject to declaration. For food sent via international mail, the declaration must be made before the shipment is dispatched, and the approval number appears on the customs declaration. Effective October 1, 2026, the name of the shipping company and the tracking number will also be required.
Conclusion
FDA Prior Notice is a notification that must be submitted for every shipment and is subject to specific timeframes measured in hours: 2 hours for road transport, 4 hours for rail and air transport, and 8 hours for sea transport. For mail, the notification is submitted before the goods are shipped, and the approval number is added to the customs declaration.
The regulation, which took effect at the end of 2025, established a deadline for submitting information for shipments that were rejected or held, and made it mandatory to include a tracking number for shipments starting October 1, 2026. Since the rules are subject to change, it’s a good idea to verify them on fda.gov before proceeding.
To set up your notification, registration, and customs compliance together, you can contact us through our FDA registration and certification services or our U.S. and Canadian customs processes page.
Son güncelleme: 10 Eylül 2026
