Food that arrives at a US port without the right FDA paperwork is not simply delayed. Under FDA's rules it can be refused, held at the port or in a secure facility, and kept away from the buyer until the gap is fixed or the cargo is exported or destroyed. Three separate obligations sit behind that outcome: Prior Notice filed before the cargo arrives, FDA food facility registration of the manufacturer, and a Foreign Supplier Verification Program (FSVP) run by a named US importer. They are filed by different people, on different clocks, and the customs broker is not automatically responsible for all of them.
This guide covers what the regulations actually say, as of October 2026, for shippers, importers and the forwarders and brokers who handle their food cargo. It is a practical explainer, not legal advice. It covers FDA only. Meat, poultry and egg products, plant and animal health permits, and the ordinary customs entry are separate matters, set out near the end.
The three FDA obligations at a glance
| Obligation | What it is | Who carries it | When |
|---|---|---|---|
| Prior Notice | An electronic notification to FDA about each food shipment (21 CFR Part 1, Subpart I) | Any person with knowledge of the required data, often the broker as transmitter | Before arrival, with a minimum lead time set by transport mode |
| Facility registration | FDA registration of the facility that manufactures, packs or holds the food (Subpart H) | Owner, operator or agent in charge of the facility, with a US agent for foreign facilities | Before it starts supplying food for US consumption, renewed every even-numbered year |
| FSVP | A written program to evaluate and manage the foreign supplier (Subpart L) | The FSVP importer, defined as the US owner or consignee at entry | Before importing, then ongoing, with the importer identified on every food line at entry |
Prior Notice and FSVP are independent. FDA's own guidance says plainly that complying with FSVP for a food does not exempt it from Prior Notice, because the two serve different purposes: one is advance notification of the shipment, the other is the importer's responsibility for the safety of the supplier.
What counts as food, and what is outside the Prior Notice rule
The definition is wider than most shippers expect. Under the Prior Notice regulation, food includes fruit, vegetables, seafood, dairy, eggs, bakery goods, snacks, candy, canned foods, beverages (including alcoholic beverages and bottled water), dietary supplements and ingredients, infant formula, food and feed additives, live food animals, and animal feed including pet food. Food contact substances and pesticides are excluded.
The rule applies to food imported for use, storage or distribution in the US, which includes trade samples, food in transit through the US to another country, food for future export and food going into a US foreign trade zone. The exclusions are narrow: food an individual carries for personal use, home-made food sent as a non-business gift, food that is imported and then exported without leaving the port of arrival, diplomatic baggage, and meat, poultry and egg products that are under the exclusive jurisdiction of USDA at the time of importation.
Prior Notice: who files, what goes in, and when
Who can file
The regulation lets any person with knowledge of the required information submit a Prior Notice, and that person (the submitter) can use someone else to transmit it. In practice a customs broker or other filer often transmits it for the importer, but the information still has to come from the shipper, manufacturer and importer, and an inaccurate notice is a ground for refusal.
The minimum lead time by transport mode
The Prior Notice must be submitted and confirmed by FDA for review no later than the following before the cargo reaches the port of arrival (21 CFR 1.279):
| Mode | Minimum time before arrival at the port of arrival |
|---|---|
| Land, by road | 2 hours |
| Land, by rail | 4 hours |
| Air | 4 hours |
| Water (ocean vessel) | 8 hours |
Two details catch people out. First, the clock is measured to the port of arrival, which is the port of unloading for sea and air cargo and the border crossing for land cargo. It can differ from the port where the customs entry or in-bond movement is filed. Second, the time starts only when FDA confirms the notice for review, not when someone presses submit. There is also a ceiling: through CBP's system you cannot file more than 30 calendar days before the anticipated arrival, and through FDA's own interface no more than 15 calendar days. Food sent by international mail has its own rule, and each food article needs its own notice, so one notice cannot cover a weekly repeat shipment.
Where it is filed
There are two routes. The first is CBP's Automated Broker Interface within ACE, filed alongside the entry data. The second is the FDA Prior Notice System Interface (PNSI). If a broker's system or ACE is down, the regulation sends filers to PNSI. The practical effect is that for most commercial cargo the notice travels with the entry, but you cannot file a customs entry for food that needs a Prior Notice without one: FDA's guidance explains that HTS codes are flagged to show which foods require it.
The Prior Notice confirmation number
When FDA confirms a submission for review, it returns a PN Confirmation Number. How it travels depends on the route. If the notice was filed through PNSI, the regulation says the number must accompany the food on arrival and be given to CBP or FDA on request, and FDA's guidance says to enter it as an affirmation of compliance when the customs entry is filed. If the notice was filed through ACE, the number comes back to the filer with a "PN received" message, and FDA's guidance recommends the carrier hold a copy of the reply message. The practical rule for a forwarder: get the number into the booking file and the driver's or carrier's papers either way.
A confirmation number is not a release. FDA's guidance is explicit that it only shows the notice was received for review. FDA can still refuse the food if the notice turns out to be inaccurate or untimely, and the food must still meet every other US requirement.
What the notice must contain
Section 1.281 lists up to 18 data elements for a standard shipment. The ones that most often depend on someone upstream are:
- The FDA product code, the common or usual name and the estimated quantity, described from the largest container to the smallest package size.
- The manufacturer, for food that is no longer in its natural state: its name, and either its FDA registration number with city and country, or its full address together with the reason the registration number is not provided.
- The grower, for food in its natural state: name and growing location address, if known, or the consolidator if the growers are not known.
- The FDA country of production, the shipper, and the country from which the article is shipped.
- Anticipated arrival information: port, date and time.
- The importer, owner and ultimate consignee with full addresses, plus carrier code, mode and the bill of lading or airway bill, vessel and voyage, flight, trip, container and rail car numbers as applicable.
- Any country that has refused the article.
If information changes after confirmation, the regulation requires a resubmission, with some exceptions for quantity, arrival details and planned shipment data. A notice filed through PNSI is cancelled in PNSI; one filed through ACE is cancelled by asking CBP to cancel the entry.
What happens to food that arrives without adequate Prior Notice
Section 1.283 sets out three failures, and each makes the food subject to refusal of admission:
- No Prior Notice: the food arrives and nothing has been confirmed.
- Inaccurate Prior Notice: a confirmed notice is found wrong on review or on examination of the cargo.
- Untimely Prior Notice: the full lead time has not elapsed when the cargo arrives, unless FDA has already reviewed the notice and told CBP its response.
Refused food is treated as general order merchandise. Unless CBP agrees to an immediate export under its supervision, it has to stay within the port of entry. It moves under an appropriate custodial bond (see our guide to US customs bonds for how bonds work), cannot be entered, and cannot be delivered to the importer, owner or consignee. The regulation states that neither FDA nor CBP is liable for transport, storage or other expenses resulting from a refusal.
The routes out are time-limited. For a no-notice or inaccurate-notice refusal, a notice must be submitted or resubmitted within 10 calendar days of the refusal notice (or of FDA's answer to a review request). A request for FDA review of whether the notice is complete and accurate must be filed within 5 calendar days of the refusal, and FDA aims to answer within 5 calendar days. The food can instead be exported with CBP concurrence. If none of that happens, it is dealt with under CBP's general order rules and may only be sold for export or destroyed, unless CBP and FDA agree otherwise. FDA's later decision that food is no longer refused for Prior Notice does not mean it is admissible: other FDA rules still apply.
FDA food facility registration and the October to December 2026 window
Facilities that manufacture, process, pack or hold food for US consumption must be registered with FDA, and a foreign facility must name a US agent in its registration. Registration also requires a unique facility identifier recognised by FDA, which is a DUNS number. Registration has to be renewed every other year, between 1 October and 31 December of each even-numbered year. That makes 1 October to 31 December 2026 the current renewal window. Under 21 CFR 1.241, FDA treats a registration that is not renewed in that window as expired, and food from a facility that should have been registered but is not can be held under section 801(l).
The hold works differently from a Prior Notice refusal. The food stays at the port or a secure facility under the same general order treatment, and the facility must be registered and the registration number given to FDA within 30 calendar days of the hold notice. A request for FDA review of whether the facility needed to register must be filed within 5 calendar days of the hold.
The registration number is the thread that ties the two obligations together: it is what the Prior Notice cites for the manufacturer. Checking that a supplier's registration is current before the booking is far cheaper than discovering at the port that it lapsed.
FSVP: the importer is a defined role, not a default
FSVP is the obligation that most often lands on the wrong person. Under 21 CFR 1.500, the importer is the US owner or consignee of the food at the time it is offered for entry. If there is no US owner or consignee at that point, the importer is the US agent or representative of the foreign owner or consignee, and that agent's role must be confirmed in a signed statement of consent. FDA's guidance adds that a foreign owner cannot validly name someone without their knowledge: the designation is not valid unless they sign.
The consequences for roles are direct:
- The FSVP importer may be, but is not required to be, the importer of record at CBP, in FDA's words. The two roles are separate.
- A customs broker that files the entry is the filer, not the FSVP importer, unless it is also the owner or consignee or has signed on as the foreign owner's agent. Do not let a broker be named as FSVP importer by default.
- A named FSVP importer must have a qualified individual develop the program, evaluate the hazards in the food and the risk of the supplier, approve suppliers, carry out verification activities and take corrective action. Records are kept for at least 2 years.
For the broker side of the same role confusion, see our guide to broker versus forwarder versus filing yourself, and for a related importer-identity problem see CBP voiding importer of record numbers.
How the FSVP importer is identified at entry
For each line of food in an entry, the filer has to transmit the FSVP importer's name, email address and a unique facility identifier acceptable to FDA, which in practice is the importer's DUNS number (21 CFR 1.509). FDA's guidance says ACE prompts the filer to send either an entity role code, FSV, which then asks for the name, email and DUNS, or an affirmation of compliance code (FSX for an exempt food, RNE for food imported for research or evaluation). If none is sent, ACE rejects the line. FDA says the DUNS requirement has applied since 24 July 2022, that numbers are free from Dun and Bradstreet, and that the importer is responsible for making sure the information gets to CBP. FDA also publishes a list of FSVP importers built from entry data, and its guidance tells a party wrongly named on it to contact the filer and, if needed, file a FOIA request.
The main exemptions and modified requirements
| Situation | What the regulation says |
|---|---|
| Juice, fish and fishery products | Outside Subpart L if the foreign supplier must comply, and does comply, with the juice or seafood HACCP rules; the importer follows those rules' own importer duties instead (1.501(b)) |
| Research or evaluation food | Exempt if not intended for retail sale, labelled "Food for research or evaluation use", in small quantity, and declared electronically at entry (1.501(c)) |
| Personal consumption | Exempt if small quantity, non-commercial, not sold or distributed (1.501(d)) |
| Alcoholic beverages | Narrow exemption for suppliers that are Treasury-permitted, with limits on non-alcohol food (1.501(e)) |
| Transshipment, or import for processing and export | Exempt if not sold or distributed in the US (1.501(f)) |
| US food exported and returned | Exempt if not further processed abroad (1.501(g)) |
| USDA-regulated meat, poultry, egg products | Exempt from FSVP (1.501(h)); USDA's rules apply instead |
| Very small importers, certain small suppliers | Modified FSVP. A very small importer averages under $1 million a year for human food ($2.5 million for animal food), adjusted for inflation, over a 3-year period (1.512) |
| Food from a country FDA recognises as comparable | Reduced program if the food is not for further processing and FDA's recognition covers it (1.513) |
| Dietary supplement inputs under the supplement cGMP rule | Modified program with identification at entry still required (1.511) |
Even where an exemption or a modified program applies, check whether the entry still has to carry the correct code. An importer that qualifies for deemed compliance because it is a receiving facility under the preventive controls rules is still bound by the identification requirement at entry (1.502(c)).
The penalty for getting this wrong is stated in the regulation, not in a fee schedule: under 1.514 food is subject to refusal if the importer does not comply with FSVP, and importing food without an FSVP that meets the requirements is a prohibited act under the Federal Food, Drug, and Cosmetic Act.
"May proceed" versus hold and refusal at entry
Prior Notice, registration and FSVP identification all feed the same entry review. FDA screens each electronic entry received through ACE, and may also review it manually. FDA's own description of the process is that a message comes back to the filer saying one of four things: the product may proceed into US commerce, additional information is required, an examination is required, or the shipment appears to be subject to refusal of admission. A "may proceed" is the release decision for FDA's purposes. It is not a confirmation number and it is not a guarantee about other agencies.
| Outcome | Typical trigger | What it means for the cargo |
|---|---|---|
| May proceed | FDA's review is satisfied on the submitted data | FDA does not hold the entry; other agencies' requirements are unaffected |
| More information or examination | Data to clarify, or the product selected for a look | Cargo waits for the response or inspection; documents and a reachable filer matter |
| Refusal under 801(m)(1) | No, inaccurate or untimely Prior Notice | Held under general order rules, short post-refusal deadlines, no delivery to the consignee |
| Hold under 801(l) | Food from an unregistered facility that should be registered | Held until registration number provided, 30 calendar day window |
| Refusal under 801(a)(3) for FSVP | Importer fails to comply with FSVP for the food | Food subject to refusal; no US consignee means a US agent must be designated first |
What this guide does not cover
This is the FDA layer only. A food importer can owe more, and the agencies are separate:
- USDA FSIS regulates meat, poultry and egg products at import. Those products sit outside the Prior Notice rule and the FSVP rule because USDA has exclusive jurisdiction over them at importation. If you ship them, start with USDA, not this page.
- USDA APHIS regulates plant and animal health at the border, and some food, for example fresh produce or animal-derived products, can need its permits or inspection. Check its requirements for your specific commodity: FDA clearance does not stand in for APHIS clearance, or the reverse.
- CBP still needs the normal entry, bond, valuation and duty work. See the customs clearance guide and the import documentation checklist.
- Labelling, standards of identity, low-acid canned food process filings, and product-specific import alerts are further FDA topics not covered here.
Recent and pending changes, as of October 2026
- Prior Notice timing. The 2, 4, 4 and 8 hour lead times in section 1.279 are the current text, last amended in 2017.
- September 2025 amendment. FDA's final rule published on 25 September 2025 added a mail tracking number requirement for food arriving by international mail and addressed the post-refusal and post-hold submission windows. The mail element applies from 1 October 2026 in the regulation, and FDA's Prior Notice page describes an enforcement policy on it. If you ship by international mail, read FDA's current notice; it does not change the commercial freight timings above.
- FSVP. No new FSVP rule or compliance-date change appears in the FDA materials reviewed for this guide. The program and the DUNS identification requirement stand as described.
- Food Traceability Rule. This is a separate recordkeeping rule, not a Prior Notice or FSVP requirement. FDA states that Congress directed it not to enforce the rule before 20 July 2028 and that it intends to comply.
- Registration renewal. The biennial renewal window runs from 1 October to 31 December 2026.
A pre-booking checklist for food cargo
- Confirm the shipment is FDA food and not USDA-exclusive meat, poultry or egg product.
- Get the manufacturer's FDA registration number and confirm it is current, particularly during the October to December 2026 renewal window.
- Name the FSVP importer in writing before booking, with its legal name, email address and DUNS number, and keep any US agent's signed statement of consent on file.
- Agree who files Prior Notice and from what data, and set an internal deadline well ahead of the minimum for the mode.
- Put the PN Confirmation Number in the file and in the carrier's papers.
- Plan for the hold. Ask who pays for storage, transport to a secure facility and a custodial bond if the cargo is refused, because the regulation puts that liability on neither agency.
- Check the other agencies. If the cargo includes fresh produce or animal-derived products, ask about APHIS before the cargo sails.
Finding a forwarder or broker who handles food imports
Food is one of the commodity types where the right handler matters more than a headline rate, because the filings, the cold chain and the port timing all land on the same file. Ask any forwarder or broker how they transmit Prior Notice, who they take the FSVP importer details from, and who bears the cost of a hold. You can browse logistics companies by country, city and service in the CargoLinked directory, where listings are self-published and unreviewed, so check credentials and references yourself. Or post your shipment on the requests board, where forwarders eligible to quote can respond with a price and a validity date.
This article explains regulations in general terms as of October 2026 and is not legal advice. For authority, read the text of 21 CFR Part 1, Subpart I and Subpart L, and FDA's guidance on Prior Notice questions and answers and FSVP. Confirm the current position with FDA or a licensed customs broker before relying on it for a specific shipment.
