FDA Prior Notice: Who Files It, and When Is It Due?

Who submits it, through which system, by what deadline, and what if it goes wrong?

Importers and food brands shipping into the US often ask us:

"Our factory is registered with FDA. Do we still need Prior Notice?"

"Do the tasting samples for our trade show booth count?"

"We ship online orders to US customers by courier. Does each parcel need one?"

The short answer: anyone who has the shipment data can file FDA Prior Notice, but FDA has to confirm it before a deadline set by how the food arrives. Samples, trade-show tastings and parcels shipped by a store all need it.

Prior Notice is an electronic notice to FDA for each shipment of food, filed before it reaches the US. Per FDA's Prior Notice page, the Federal Food, Drug, and Cosmetic Act requires it for imported food, including animal feed. Facility registration does not replace it.

Our post on FSVP and FDA registration covered who does what across all three. This one goes deeper on the notice itself.

1. Who can file the notice?

Anyone who knows the required information can file it. Under 21 CFR 1.278, that person is the submitter. The submitter can have a transmitter send the data, and the two can be the same person.

What data do you need? The main items under 21 CFR 1.281 are:

The manufacturer's name and FDA registration number, or its full address and the reason the number is not given
The name and full address of the US importer
The country the food ships from, the port of arrival and the expected arrival details

FDA's CPG 110.310 says FDA intends to reject a notice without a valid registration number or one of the listed reasons. FSVP data is not a field in the notice.

Language matters too. Under 21 CFR 1.280, everything goes in English. Only a person's name, a company name and a street name may be in another language, and even those must use the Latin alphabet.

When anyone can file, it is easy to assume someone else will. The question is not who is allowed to file, but who has agreed to file this shipment. Settle that in writing before the goods leave the factory.

2. Two filing channels: CBP's ABI/ACE and FDA's PNSI

The notice is filed electronically, through one of two channels under 21 CFR 1.280:

ABI/ACE/ITDS: CBP's system, reached through a customs broker's or self-filer's software.
PNSI (Prior Notice System Interface): FDA's own portal. Per FDA's filing page, it is open to individuals and companies that cannot, or choose not to, file through CBP.

If the broker's system or the ABI/ACE link is down, the notice must go through PNSI. PNSI is not just a backup for broker outages; any company can use it from the start. If you are the importer of record, ask your broker early whether the notice goes with the entry or your team files it in PNSI. Our importer of record guide covers the broker's role.

3. FDA Prior Notice deadlines by mode of transport

FDA must confirm the notice at least 2 hours before arrival by road, 4 hours by rail, 4 hours by air and 8 hours by water (21 CFR 1.279). The port of arrival is the port of unloading, or the first border crossing by land (21 CFR 1.276).

Route	Latest	Earliest	Confirmation number	Rule
Ocean freight	8 hours before arrival	PNSI 15 days, ABI/ACE 30 days	PNSI filings: give it to CBP or FDA on arrival	21 CFR 1.279
Air freight	4 hours before arrival	PNSI 15 days, ABI/ACE 30 days	PNSI filings: give it to CBP or FDA on arrival	21 CFR 1.279
Road / rail	2 / 4 hours before arrival	PNSI 15 days, ABI/ACE 30 days	PNSI filings: give it to CBP or FDA on arrival	21 CFR 1.279
Express courier (FedEx, UPS, DHL)	Deadline for the mode (4 hours by air)	PNSI 15 days, ABI/ACE 30 days	Courier tracking number can replace arrival details	21 CFR 1.276, 1.281
International mail	Before the parcel is sent	No 15- or 30-day limit	On the customs declaration (CN22 or CN23)	21 CFR 1.279

Under 21 CFR 1.279, the notice counts as submitted, and the hours start, when FDA confirms it. The deadline runs from FDA's confirmation, not from when you hit submit.

For example, an air shipment landing at 6 p.m. needs FDA's confirmation by 2 p.m. If it comes at 3 p.m., the food lands before 4 hours have passed. Under 21 CFR 1.283, that is untimely notice and the food is subject to refusal, unless FDA has already reviewed it and told CBP its response.

4. The confirmation number has to travel with the food

When FDA confirms a notice, it replies with a PN Confirmation Number (21 CFR 1.279). Where it goes depends on the route:

International mail: on the customs declaration (CN22 or CN23) attached to the parcel.
Food carried by a traveler and not for personal use: a copy of the confirmation goes to CBP or FDA on arrival.
Anything filed through PNSI: the number goes with the food to CBP or FDA on arrival.

For example, a sales manager flying to a trade show with samples in a suitcase should pack a copy of the confirmation too. The confirmation number is not something you file away; it has to arrive with the food.

5. Samples, trade-show tastings and store parcels need Prior Notice

Samples need Prior Notice. 21 CFR 1.277 covers food for gifts and trade and quality control samples. CPG 110.310 adds that there is no exemption based on the size or value of a shipment.

The CPG's enforcement discretion is narrow:

Small test samples: FDA and CBP may take no action on small samples used only for quality assurance, research or analysis, then used up or destroyed. This does not apply to test-marketing samples, "such as tasting at trade shows or product promotional tasting events."
Personal shipments: staff typically take no action on food sent for non-commercial purposes by an individual. CBP's personal shipments page describes this as enforcement discretion.
Store shipments: in the CPG's example, if a store ships the food, the store is the shipper, and the personal-shipment policy does not apply.

FDA's draft Q&A guidance (Edition 4) also says trade samples carried by a traveler are not exempt. Our de minimis post covers the duty side of shipping orders straight to US customers.

The real exemptions are the ones listed in 21 CFR 1.277:

Food for personal use that a traveler carries on arrival
Food made in someone's home and sent as a personal gift to an individual in the US
Food imported and then exported without leaving the port of arrival
Meat, poultry and egg products under USDA's exclusive jurisdiction
Food in a diplomatic bag

A gift bought in a store does not fit the homemade-gift exemption. Whether the rule applies turns on who ships the food and why, not on how small the shipment is.

6. International mail: file before sending, and add the tracking number

Food sent by international mail needs Prior Notice before the parcel leaves for the US (21 CFR 1.279). The hour-based deadlines do not apply to mail.

Under 21 CFR 1.276, international mail means national postal services. Express couriers such as FedEx, UPS and DHL are not international mail unless they act as an agent of a foreign mail service, so they follow the deadline for their mode.

The 2025 rule added two mail fields:

October 1, 2026: under 21 CFR 1.281, a notice for food arriving by international mail must include the mail service name and the tracking number.
May 1, 2027: FDA says it does not expect industry to submit these two items before this date.

This covers all food sent by international mail, not only samples.

If a mail parcel has inadequate notice or no confirmation number on it, CBP holds it for 72 hours for FDA inspection (21 CFR 1.283). If FDA refuses it and there is a return address, the parcel may go back marked "No Prior Notice - FDA Refused." With no return address, or if the food looks hazardous, FDA may destroy it.

For mail, the deadline is the day the parcel leaves, not the day it lands.

7. Refusals and holds: the 10-day and 30-day windows

Food with no notice, an inaccurate notice or a late notice is subject to refusal of admission (21 CFR 1.283). Unless CBP agrees to an immediate export under its supervision, the food must stay within the port of entry.

Under the same rule:

Status: refused food is treated as general order merchandise under CBP rules.
Resubmission: if there was no notice, file one within 10 calendar days of the refusal notice. If the notice was inaccurate, resubmit within the same 10 days.
No action: if nobody resubmits, requests FDA review or exports, the food may only be sold for export or destroyed, unless CBP and FDA agree otherwise.
Costs: FDA and CBP are not liable for transportation, storage or other costs from a refusal. Raise cost questions with your customs broker before shipping.

The 10-day window comes from the final rule published September 25, 2025 and effective October 27, 2025 (90 FR 46045).

Food from an unregistered foreign facility is not refused but held. Under 21 CFR 1.285, a valid registration number must reach FDA within 30 calendar days of the hold notice, and mail parcels are held by CBP for 72 hours. For the 2026 registration renewal dates, see our FSVP post.

A refusal over the notice gives you 10 days; a hold over registration gives you 30.

Four checks before the next shipment

Run through these before the goods leave.

1. Who files the notice for this shipment, and through ABI/ACE or PNSI?

2. Is the deadline counted from FDA's confirmation, for the actual mode of transport?

3. Are the manufacturer's registration number and the importer's name and address correct, and is the registration current?

4. For samples or mail parcels, is the confirmation number on the customs declaration or in the traveler's bag?

Wrap-up

Because anyone can file, the notice is easy to miss. This post summarizes the rules and is not legal advice. For an unclear shipment, check with a licensed customs broker, FDA counsel or FDA. Per FDA's Prior Notice page, its Division of Targeting and Analysis answers questions 24/7 at 866-521-2297 and prior.notice@fda.hhs.gov.

LinkONE supports FDA facility registration, FSVP documentation and import regulation compliance from its warehouse in Fullerton, California.

In the end, FDA Prior Notice is a filing anyone can make, which is why each shipment needs a named person who will.

Frequently Asked Questions

Who can file FDA Prior Notice?

Anyone with the required information can file it. Under 21 CFR 1.278, that person is the submitter and can have a transmitter send it. It goes through CBP's ABI/ACE or FDA's Prior Notice System Interface (PNSI) (21 CFR 1.280).

Do trade show samples need Prior Notice?

Yes. 21 CFR 1.277 covers food for trade and quality control samples, and CPG 110.310 says there is no exemption based on size or value. The same CPG excludes trade-show tasting and promotional tasting samples from its small-sample policy.

Do FedEx, UPS or DHL shipments follow the international mail rules?

No. Under 21 CFR 1.276, express couriers are not international mail unless they act as an agent of a foreign mail service. A courier shipment needs Prior Notice confirmed before the deadline for its mode, for example 4 hours before arrival by air (21 CFR 1.279).

Does an overseas online store shipping to US customers need Prior Notice?

Yes. CPG 110.310 limits its discretion to food sent for non-commercial purposes by an individual. When a store ships the food, the store is the shipper, and the policy does not apply.

What happens if Prior Notice is late or wrong?

The food is subject to refusal and stays in the port unless CBP agrees to an immediate export (21 CFR 1.283). You can resubmit within 10 calendar days of the refusal notice. With no action, the food may only be sold for export or destroyed, and FDA and CBP are not liable for transportation or storage costs.

Sources

Rules in this post are as of October 2026.

-LinkONE-