FDA Prior Notice: Filing Windows, Exemptions and 801(m) Refusals

Every shipment of food bound for the United States has to be announced to FDA before it reaches the port, and the announcement has to be right. FDA prior notice is the advance electronic filing that tells the agency what the food is, who made it, who shipped it and when and where it will arrive. File it late, leave it out or get a required field wrong, and the food is subject to refusal under section 801(m) of the Federal Food, Drug, and Cosmetic Act, held at the port or a secure facility, and kept away from the importer until the problem is fixed.

The requirement dates from the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which added 801(m) to the statute, and the working rules sit in 21 CFR 1 subpart I (sections 1.276 to 1.285). What follows covers who must file and for which products, the minimum lead times by mode, the choice between FDA’s own portal and the customs system, the exemptions that actually apply, and the data errors that most often turn a routine food entry into a refusal. Regulatory text checked against the eCFR as of September 2026.

Who Must File Prior Notice and Which Foods It Covers

The trigger is the product, not the importer. Prior notice applies to food for humans and for animals as defined in FD&C 201(f), and the regulation spells out how wide that is: animal feed including pet food, dietary supplements and dietary ingredients, infant formula, and beverages including alcoholic beverages. Food contact substances and pesticides are excluded from the definition (21 CFR 1.276(b)(5)). A container of canned tuna, a pallet of whey protein, a load of dog treats and a shipment of wine all need a notice.

Scope also reaches shipments that many importers assume are outside it. Section 1.277(a) expressly includes gifts, quality assurance and quality control samples, food for transshipment through the United States, food imported for future export, and food admitted to a foreign-trade zone. A trade show sample carton and an in-bond load crossing from Canada to Mexico are both in.

Medical devices, drugs and cosmetics are not food and never need prior notice. Subpart I applies only to articles of food (1.277). Device entries clear through FDA admissibility review under 801(a) using device registration, establishment and listing data, which is the territory of the FDA initial importer role rather than a prior notice filing.

On who files, the regulation is flexible. Any person with knowledge of the required information can be the submitter, and the submitter may use a transmitter to send it, which in practice is usually the customs broker (1.278). The shipper, the importer or the broker can file. What does not change is that the food is refused if the notice is wrong, whoever typed it, so the allocation of that risk belongs in the contract between the parties.

Prior Notice Timing Windows by Mode of Transport

Section 1.279 sets minimum lead times before arrival at the port of arrival, and they differ by mode. The windows are short enough that a missed filing is usually discovered after the conveyance is already underway, which is why they belong in the booking workflow rather than the arrival workflow.

The clock does not start when the notice is transmitted. It starts when FDA confirms the notice for review (1.279(d)). A truck that reaches the border crossing before the 2 hour window has run from confirmation carries an untimely notice and the food is subject to refusal, unless FDA has already reviewed the notice and advised CBP (1.283(a)(1)(iii)). For road freight in particular, a notice sent while the driver is at the last warehouse before the border can leave no margin at all.

The maximum advance filing is 30 calendar days before arrival when the notice goes through ABI/ACE/ITDS, and 15 calendar days through FDA PNSI (1.279(b)). For ocean freight with long transit times, that ceiling matters: a notice cannot be filed at booking for a voyage that arrives more than 30 days later, so it has to be scheduled into the transit.

From October 1, 2026, a prior notice for food sent by international mail must also carry the name of the mail service and the mail tracking number (21 CFR 1.281(b)(10)).

PNSI vs ACE Filing and the Prior Notice Confirmation Number

Filing is electronic only, through one of two channels (1.280). The first is ABI/ACE/ITDS, used by a licensed broker or a self-filing importer. The second is FDA’s Prior Notice System Interface, PNSI, reached through access.fda.gov. PNSI becomes mandatory when the broker’s or self-filer’s system, or ABI itself, is down. Either way, the notice must be in English, with personal, company and street names allowed in their original language, and every field must use the Latin alphabet.

Inside ACE there are two ways to send it. A stand-alone prior notice carries only the prior notice data. A combined entry sends the prior notice data together with the FDA 801(a) entry data under the same transmission. FDA’s Industry Quick Reference Guide to the ACE Supplemental Guide, dated March 10, 2026, keeps separate data tables for each, and a broker working a mixed book of food and non-food lines needs to know which one the entry is using.

For most commercial food entries handled through customs brokerage, ACE is the practical choice: it allows the longer 30 day window, sits inside the same workflow as the CBP entry and avoids retyping data. PNSI suits a shipper with no broker yet appointed, a one-off sample, or a system outage.

The PN Confirmation Number is FDA’s reply confirming the notice for review (1.279(d)). It is the proof that the clock has started. The regulation requires it to travel with the goods in three cases: food sent by international mail, where it goes on the customs declaration; food carried by or accompanying a traveler; and any food whose notice was filed in PNSI (1.279(e) to (g)). Keep the number on the shipping file for every food line, because it is the first thing anyone asks for when a shipment stops.

Prior Notice Exemptions and What Stays in Scope

The exemptions in 1.277(b) are narrow and specific. They do not follow value, quantity or commercial intent, which is where most wrong assumptions come from.

Two traps sit around these exemptions. The first is mixed jurisdiction: a product that contains meat or poultry but is not under exclusive USDA jurisdiction at the time of import still needs FDA prior notice, so each formulation needs a case-by-case check rather than a blanket rule for the category. The second is the port exemption, which covers only food that never leaves the port of arrival before export. Food moved in-bond to another port, or into a warehouse or zone, is back in scope.

Samples are not exempt. A small sample box of snack bars sent to a buyer for evaluation needs the same notice as a container, including manufacturer data, and a missed notice on a sample gets the same refusal treatment.

• Food for personal use carried by or accompanying an individual.
• Homemade food sent by an individual as a personal, non-business gift.
• Food imported and then exported without leaving the port of arrival.
• Meat food products, poultry products and egg products under the exclusive jurisdiction of USDA under the FMIA, PPIA or EPIA.
• Items in a diplomatic bag under article 27(3) of the Vienna Convention on Diplomatic Relations.

Refusal Under 801(m) and the Filing Errors Behind It

Section 1.283 treats three failures the same way. Food with no prior notice, an inaccurate prior notice or an untimely prior notice is subject to refusal of admission under 801(m)(1). Unless it is immediately exported under CBP supervision, it must be held within the port of entry unless CBP or FDA directs otherwise, and if it goes to a secure facility outside the port, FDA must be told the location before it moves.

This is a harder track than the ordinary FDA review most importers know. The refused food becomes general order merchandise under 19 U.S.C. 1490, moves only under custodial bond, and may not be delivered to any importer, owner or ultimate consignee. Release under the importer’s bond is not available. Neither FDA nor CBP is liable for transportation or storage while it sits, so every day of the hold is charged to the cargo interests.

There is a way back. A post-refusal prior notice must be submitted within 10 calendar days of the refusal notice, both where no notice was filed and where an inaccurate notice has to be cancelled and resubmitted (1.283(c)). If the importer instead asks FDA to review whether the food is in scope or the notice was accurate, that request is due within 5 calendar days of the refusal (1.283(d)), and the 10 days then run from FDA’s response. Miss the deadline, and unless CBP and FDA agree otherwise, the goods move to general order procedures under 19 CFR part 127, where they may only be sold for export or destroyed. If a refused article is exported instead, the notice should be cancelled within 5 business days (1.283(a)(5)).

The exposure goes beyond the shipment. Importing food in violation of 801(m) is a prohibited act under 301(ee) of the FD&C Act, which opens the door to injunction under section 302, prosecution under section 303 and, for felony convictions or a pattern of importing adulterated food, debarment under section 306 (1.284). Food from a foreign facility that is not registered with FDA is held on a separate basis, under 801(l), even when the prior notice itself is perfect.

The data fields that cause most inaccurate notices

Section 1.281(a) lists the required data. The fields below are the ones that most need checking against the cartons, and each one is checkable before the goods move.

• Manufacturer, for food no longer in its natural state: name plus food facility registration number, city and country, or the full address plus the reason no number is given. In ACE the number goes in the PFR affirmation of compliance, or FME with an exemption reason code.
• Grower, for food in its natural state, where known; otherwise the consolidator.
• Shipper, where it differs from the manufacturer.
• The complete FDA product code, built with FDA’s Product Code Builder. A code that describes the wrong product form is an inaccurate notice.
• Quantity described from the largest container down to the smallest package.
• Lot or code numbers where the product rules require them, such as low-acid canned foods, acidified foods and infant formula.
• Carrier SCAC or IATA code, bill of lading or air waybill number, and the anticipated port, date and time of arrival. An express courier tracking number may substitute.
• Importer, owner and ultimate consignee, which are not required for transportation and exportation in-bond moves.
• Any country to which the article has been refused entry.

Building Prior Notice Into the Food Import Workflow

The cleanest programs treat prior notice as a supplier data problem solved before the first order, not a filing problem solved at arrival. Collect the manufacturer’s registration number, full address, product codes and lot coding practice once per SKU, validate them, and store them where the filer can reach them. Registration data is not publicly searchable, so the number has to come from the supplier itself.

The FSVP line belongs in the same checklist. For each food line covered by the Foreign Supplier Verification Program (FSVP), the importer’s name, email and unique facility identifier must be transmitted at entry (21 CFR 1.509(a)); lines that qualify for an FSVP exemption declare it with an exemption code instead. It is a separate requirement from prior notice, but it is reviewed at the same time and a gap there stops the same entry.

Then tie the filing to the transport plan: trigger the notice from the booking confirmation for ocean, from the flight assignment for air, and from the dispatch for road, with the minimum window measured from FDA confirmation rather than transmission. Food is one of several categories of restricted imports into the US, and the same pre-shipment discipline applies to the other agencies that regulate them.

For importers moving food across several modes and origins, running prior notice as part of a wider trade compliance management program keeps supplier data, product codes and filing windows in one place. CargoTrans works with food and beverage importers on exactly this data set, and coordinating the notice with import and export freight means the filing and the transport plan come from the same file.

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