FDA Prior Notice: filing the US food-import notification correctly

title: "FDA Prior Notice: filing the US food-import notification correctly" description: "Every commercial food shipment to the United States needs an FDA Prior Notice filing before arrival. Miss it and the shipment is refused at the port. Here's how the system works." category: "commercial-importing" estimatedReadMinutes: 8 lastUpdated: "2026-06-12"

Prior Notice (PN) is the US Food and Drug Administration's pre-arrival notification system for imported food, beverages, and animal feed under section 801(m) of the Federal Food, Drug, and Cosmetic Act (added by the Bioterrorism Act of 2002). Every commercial food import into the US must be electronically notified to FDA before arrival. Goods that arrive without a confirmed Prior Notice are refused entry and held at the port at the importer's cost until either a corrected PN is filed or the goods are re-exported.

Prior Notice is separate from — and in addition to — the regular CBP entry. It is also separate from FDA's Foreign Supplier Verification Program (FSVP) and Food Facility Registration. All three are required for most commercial food imports.

What counts as "food" under PN

The FDA definition is broad: "articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article." This includes:

Fresh fruit, vegetables, meat, poultry, seafood, dairy
Processed food and beverages of every kind
Dietary supplements (vitamins, minerals, herbal supplements)
Infant formula and baby food
Animal feed and pet food
Ingredients sold to manufacturers (food additives, flavours, colours)
Food contact substances (where the substance is the entity being imported)
Functional foods and "food-as-medicine" products

Excluded from PN: meat and poultry under USDA FSIS jurisdiction (USDA has its own equivalent process); homemade food carried in personal baggage in non-commercial quantities; food for personal consumption sent to a US individual under 5 kg; some research and trade samples below specified thresholds.

When to file

PN must be received and confirmed by FDA before the shipment arrives at the US port of entry. The minimum lead times by mode:

Land arrivals (truck or rail from Canada/Mexico): 2 hours minimum, max 30 days
Air shipments: 4 hours minimum, max 15 days
Sea shipments: 8 hours minimum, max 30 days
International mail: any time before arrival, max 30 days

In practice, most filers submit 24-48 hours before arrival for air and 3-5 days for sea, which gives time to receive the PN confirmation, fix any errors, and present the confirmation number to the customs broker for entry filing.

How to file

PN is submitted through one of two channels:

ACE entry system via the broker's software — most commercial entries combine the FDA PN data with the CBP entry submission in a single ACE filing. The broker submits PN data through the FDA Prior Notice System Interface (PNSI), receives a confirmation number, and includes that number in the customs entry.
FDA's standalone Prior Notice System Interface (PNSI) — a web portal at access.fda.gov for filers who don't have ACE integration (small importers, individuals receiving commercial samples). Free to use but requires an FDA Industry Account and Submitter Identifier.

A complete PN submission requires:

FDA Product Code (a 7-character code from FDA's product code builder)
Manufacturer/processor (Food Facility Registration number, FFR)
Shipper (the entity sending the shipment, with country and address)
Grower (for fresh produce only)
Importer of record (matched to the IRS/EIN)
Mode of transit and carrier
Estimated arrival date, time, and port
Product description (common name, scientific name where applicable, packaging, lot/batch)
Quantity (per FDA's specified UOM)
Country of production
Country of shipment (often different from production country)
All countries through which the article transited

Food Facility Registration: the prerequisite

PN can only be filed for products manufactured at a facility registered with FDA via Food Facility Registration (FFR), required under section 415 of the FD&C Act. FFR is free, biennial (renewed every even-numbered year between October and December), and required for any non-US facility that "manufactures, processes, packs, or holds" food intended for US consumption. Without an active FFR, your supplier's product cannot legally be imported.

Most ecommerce-platform fulfilment failures trace to suppliers without FFR. Verify FFR validity (and that the registration matches the actual production address) before contracting.

Foreign Supplier Verification Program (FSVP)

Since 2017, US importers of food (other than those exempt) must implement an FSVP under FDA's Food Safety Modernization Act. The FSVP requires the importer to:

Identify the supplier (production facility) and the hazards in the food
Determine that the supplier is producing under controls equivalent to US FDA standards (HARPC under 21 CFR 117)
Verify with on-site audits, sampling, or supplier-management records on a schedule based on hazard severity

FSVP records must be maintained at a US location and produced on FDA request. Failure to implement FSVP is grounds for shipment refusal even when the PN is correct.

What goes wrong

No PN confirmation number on the customs entry: the entry is rejected, the shipment goes into FDA hold at port. Daily storage fees accumulate ($30-150 per day per container).
Product code wrong: FDA's automated system flags the entry for manual review, adding 24-72 hours. Critical for refrigerated/perishable shipments.
Facility registration expired: every PN tied to that facility is invalid until renewal. Block on every shipment from the supplier.
Country of production vs country of shipment mismatched: a frequent issue with shipments transiting via consolidation hubs. Both must be declared correctly.
PN filed too early: the 30-day maximum window starts at filing, not at arrival. If your shipment is delayed beyond the window, you'll need to refile.
FDA "Detention Without Physical Examination" (DWPE): an Import Alert applied to a specific supplier, country, or product category. Goods on a current DWPE list are detained by default and require the importer to prove compliance (lab results, FSVP records) before release.

The DWPE / Import Alert system updates monthly. Check accessdata.fda.gov/cms_ia/iaall.html for the live list before sourcing from a new supplier.

Practical compliance flow

For a US importer onboarding a new food supplier:

Verify the supplier's FFR is current via FDA's FFR search.
Verify the supplier and product are not on a current Import Alert.
Build FSVP file: supplier audit, hazard analysis, verification activities.
File Prior Notice 24-72 hours before arrival via the broker's ACE filing.
Confirm PN acceptance (confirmation number issued, no errors).
Customs broker submits the entry with PN confirmation included.
CBP and FDA review; if cleared, goods released; if flagged, sample or refuse.

For occasional importers and ecommerce sellers, working through a US-based fulfilment partner (Amazon Multi-Channel Fulfilment, ShipBob, etc.) outsources the entry and Prior Notice burden to the partner's licensed broker network. Margin cost is typically 5-15% of landed value but eliminates the FFR/FSVP/PN compliance overhead from your operation.