Reviewed by Mason Weeda (FDA)
Most food-import trouble starts with FDA Prior Notice, and it almost never looks like trouble at the time. A filing goes in a little late, or with a product code that does not match the entry, and the paperwork seems fine. Then the container is sitting at the port, the demurrage clock is running, and CBP and FDA are working through a file that should have been closed before the ship left the foreign dock.
Two agencies meet your shipment, and they are not reading it the same way. CBP cares about classification, duties, and release. FDA reads the entry for food-safety problems, and it starts with labeling, registration, Prior Notice, and Foreign Supplier Verification Program (FSVP) compliance. If a supplier is loading a container this week, that whole document set should already be done, not half-built.
Which Federal Agencies Control Your Food Import
On the FDA side, the governing texts are the Federal Food, Drug, and Cosmetic Act, FSMA, and 21 CFR Part 1. A shipment can clear one agency and still get held by the other, which is why the first thing to nail down is which agency regulates your product. Meat, poultry, and processed egg products go to USDA, not FDA, and from there the whole import path changes.
For most human food that is not meat or poultry, three FDA items decide whether the goods come in: a timely Prior Notice, an FSVP file, and a live registration for the foreign facility. Miss one and the shipment does not move, no matter how clean the other two are.
FDA Prior Notice Stops Food at the Port When It Is Wrong
Prior Notice is the heads-up that tells FDA food is on the way in. Before it lands, the agency decides what happens to it. Release, inspection, sampling, or a hold. The requirement came out of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and it now lives at 21 CFR Part 1, Subpart I. FDA lays out the steps on its Filing Prior Notice of Imported Foods page.
Get it wrong and FDA can refuse the food under section 801(m) of the FDCA, and CBP will not release refused food without an FDA clearance. That is the whole reason Prior Notice belongs at the front of the compliance check rather than wherever the broker happens to get to it.
Who Can Submit Prior Notice
The rule is broader than most importers assume. Under 21 CFR § 1.278, anyone with knowledge of the required information can file it, which day to day means the importer, the owner, a U.S. agent, or, most often, the licensed customs broker running the entry. Whoever clicks submit owns the accuracy. That detail matters more than it sounds, because “the broker handled it” is not a defense if the broker handled it wrong.
Filings travel through one of two systems.
- PNSI, FDA’s standalone Prior Notice System Interface, used when the filing is not tied to a CBP entry or when a broker files it on its own.
- ACE, CBP’s Automated Commercial Environment, where Prior Notice rides along with the customs entry. Most commercial shipments go this way so everything moves together.
Prior Notice Filing Deadlines by Mode of Transport
How the food travels sets the clock. FDA fixes a minimum advance window by mode, and filing outside it is, by itself, a reason to refuse.
| Mode of Transport | Minimum Advance Notice Before Arrival |
|---|---|
| By land, road | No less than 2 hours |
| By land, rail | No less than 4 hours |
| By air | No less than 4 hours |
| By water (sea) | No less than 8 hours |
Treat those as floors, not goals. Filing early buys FDA time to clear the entry and buys you time to fix a rejected submission before the goods are actually sitting there.
What a Prior Notice Must Contain
Under 21 CFR § 1.281, the filing has to name the food and its FDA product code, the manufacturer, the shipper, and the grower where one applies. It also carries the country of production, the importer, the owner, and the arrival details. One mismatch, a product code or a manufacturer registration number that does not line up with the customs entry, is enough for FDA to kick it back.
Foreign Supplier Verification Program Requirements
FSVP moves the job of vouching for foreign food safety onto the U.S. importer. Under 21 CFR Part 1, Subpart L, the FSVP importer has to verify that each foreign supplier is producing food under processes that meet U.S. safety standards.
The trap is in who counts as that importer. The FSVP importer is the U.S. owner or consignee at the time of entry, or, when there is no U.S. owner or consignee, the U.S. agent the foreign owner names. That is frequently not the same party as the importer of record for customs. A company can be importer of record for the duties while a different entity carries the FSVP obligation, and FDA holds the FSVP importer answerable no matter whose name went on the customs paperwork.
FSVP is also not a one-and-done filing, which catches people. It runs on a written hazard analysis, supplier evaluation, verification activities, corrective actions, and records FDA can ask for at any point. The full mechanics, and how to build a file that actually survives an audit, are in our guide to FSVP importer responsibilities.
Food Facility Registration Before Entry
A facility outside the United States has to register with FDA under 21 CFR Part 1, Subpart H if it manufactures, processes, packs, or holds food meant for U.S. consumption. Registration renews every even-numbered year, in the window from October 1 through December 31. It is an easy date to let slide, and the consequence is not small.
Let it lapse and the food can sit at the port, because a Prior Notice built on an expired or invalid registration number fails for that alone. Foreign facilities also need a U.S. agent for FDA communications. The habit worth building is confirming a new supplier’s registration before the first container leaves, since food facility registration gaps tend to surface only once the goods are already moving and the options have narrowed.
How FDA and CBP Screen Imports at Entry
Once an entry is filed, FDA’s screening tools run the Prior Notice and entry data against risk criteria. The shipment can be released, flagged for more information, held for review, examined, or sampled. A flag is not a refusal yet. What you do in the first 24 to 48 hours usually settles which way it goes. Certificates of analysis, processing records, label files, supplier records, registration documents, handed over fast, can turn a hold back into a release.
Why FDA Detains Food Shipments
Detention is the formal hold FDA puts on a shipment that looks like it violates the FDCA. The agency issues a Notice of FDA Action and gives the importer a limited window to answer with evidence or testimony. If that answer does not land, the food is refused, and refused food has to be exported or destroyed under FDA and CBP supervision.
The reasons repeat year after year:
- Prior Notice that was missing, late, or wrong. This is the one that should never happen and still does, constantly.
- Labeling violations, like no English labeling, missing nutrition facts, or an allergen nobody declared.
- Filth or sanitation findings that usually trace back to conditions at the supplier’s facility.
- Pesticide or contaminant levels over the tolerances FDA enforces.
- An FSVP file the importer cannot produce when the agency asks for it.
Some commodities draw a closer look no matter how clean your file is. Tea, fresh coconut, and certain spices carry contaminant and adulteration histories, so they land in the sampling line more often than a low-risk packaged good ever will.
Import Alerts and Detention Without Physical Examination
When a product, a producer, a country, or a condition builds a track record of violations, FDA can issue an Import Alert that authorizes Detention Without Physical Examination. A shipment caught by one is held on sight, and the burden flips. Now you have to prove the food complies, usually with independent lab results the agency will accept, before anything moves.
Getting off an alert is slow, document-heavy work, built on a petition backed by a run of compliant shipments, and the goods arriving in the meantime stay exposed. Importers buying through intermediaries they do not really know carry an extra layer of risk here, the kind I get into in our look at grey-market import risks, where the chain of custody and the supplier records are harder to stand behind.
And not every hold is about safety. CBP detentions tied to the UFLPA entity list stop shipments over forced-labor concerns entirely. The same container can be facing an FDA question and a CBP question at once, which is its own kind of bad week.
A Pre-Import Compliance Checklist
Before a food shipment leaves the foreign port, confirm all of this is in place:
- Facility registration is active and the FDA registration number is current.
- Prior Notice is built with the right product code, manufacturer, and shipper data, ready to file inside the mode-specific window.
- FSVP records exist for the supplier, including the hazard analysis and the most recent verification activity.
- Labeling meets U.S. rules: English, accurate nutrition facts, full allergen declarations.
- Product testing results are on hand for any commodity with a contaminant history or an active Import Alert.
- The customs entry data matches the Prior Notice exactly, with no codes or addresses out of sync.
An importer who can say yes to all six rarely sees a preventable refusal. The shipments that stall almost always left the foreign port with one of these still open, which is the frustrating part, because that is the cheapest possible place to fix it.
When to Bring in Import Counsel
Routine entries do not need a lawyer. The moments that do are the ones where a wrong answer costs you the goods. A detention with a response clock running. A producer just added to an Import Alert. An FSVP records request from FDA. A run of refusals that says the problem is the program, not the shipment. In those spots the response has to be fast and exact, and how the evidence gets framed can be the difference between a release and a destruction order.
If the goods are already held, the work shifts from preventing the problem to recovering from it. Our guidance on what to do if CBP detains your shipment covers the first moves, and the firm’s customs and trade practice handles detention defense, Import Alert petitions, and FSVP audits directly. If you are building a program from scratch, it also helps to understand the broader FDA compliance obligations sitting behind every food entry.
Importer Questions FDA Sees Often
Who is authorized to submit an FDA Prior Notice?
Broader than people expect. Anyone with knowledge of the required information can submit it, which usually means the importer, the owner, a U.S. agent, or a licensed customs broker filing for the importer. Whoever submits stays responsible for the accuracy.
What are the deadlines for filing Prior Notice?
FDA sets a minimum advance window by mode: no less than 2 hours for arrival by land road, 4 hours by rail, 4 hours by air, and 8 hours by water. File earlier than that when you can, because it leaves room to fix a rejected submission before the goods arrive.
Are any food items exempt from Prior Notice?
Yes, though the exemptions are narrow. Food an individual carries for personal use, and certain food made by an individual at home and shipped as a non-commercial gift, fall outside it. Food imported for resale does not, and commercial samples generally still need Prior Notice.
What is the difference between filing in PNSI and ACE?
PNSI is FDA’s standalone portal, used when the filing is not tied to a CBP entry. ACE is CBP’s system, where Prior Notice is filed together with the customs entry. Most commercial shipments go through ACE so the data moves with the entry.
What is the difference between the FSVP importer and the importer of record?
The importer of record answers to CBP for the entry and the duties. The FSVP importer is the U.S. owner or consignee at entry, or the U.S. agent of a foreign owner. FDA holds that FSVP importer answerable for supplier verification even when someone else filed with customs.
If FDA detains my food shipment, what happens next?
FDA sends a Notice of FDA Action stating the apparent violation, and you get a limited window to come back with evidence or testimony. If that does not resolve it, FDA refuses the food, and the goods have to be exported or destroyed.
How does an Import Alert affect my shipments?
An Import Alert can put your product on Detention Without Physical Examination, so shipments are held on sight and you have to prove compliance, often with independent lab results, before entry. Getting removed takes a documented petition showing a run of compliant shipments over time.
What FDA documentation is required to import food into the U.S.?
FDA does not ask for one master form. What it actually reaches for, during a screening hold or a records request, is four things: the foreign facility’s current registration number, the Prior Notice confirmation with a product code and manufacturer data that match the customs entry, the FSVP importer’s hazard analysis and latest supplier verification, and label proof showing English text, nutrition facts, and allergen declarations. Missing FSVP records is one of the more common reasons a routine hold turns into a longer review, since unlike Prior Notice, nobody checks that file exists until FDA asks for it. J. Mason Weeda works with importers on building files that hold up when FDA asks.
This article is for informational purposes only and does not constitute legal advice. Consult a qualified attorney about your specific situation. For questions about importing food into the United States, contact the OFW Law team.
Facing a Detention or Building Your Import Compliance Program?
OFW Law represents importers on Prior Notice and FSVP compliance, FDA detentions, and Import Alert petitions. Connect with our customs and trade team about your shipment or your compliance program.
