FDA Imports · 21 CFR Part 1 Subpart I

FDA Prior Notice Checker — is it required, and when must you file?

Do you need an FDA Prior Notice and by when? Enter the shipment below for a cited verdict + the exact submit-by datetime. Rules verified (21 CFR 1.276–1.285; effective 2025-10-27).

Prior Notice — Filing Slip21 CFR 1.279 / 1.281
ABI/ACE · PNSI

Minimum file-by lead time before arrival, by mode

  • 2 hRoad
  • 4 hRail
  • 4 hAir
  • 8 hWater
  • pre-mailMail

Floors, not targets. The slip below computes your exact submit-by datetime in port-local time and subtracts a safety buffer — file early.

Shipment parameters

Verdict and deadlines

Rules effective 2025-10-27 · verified 2026-06-16 · dataset 2026.06.16

Determination

Prior Notice IS required

Minimum lead time
8 h

21 CFR 1.279(a)

Must be confirmed by (legal deadline)
2026-07-15 06:00

arrival − 8 h, in America/Los_Angeles

Submit by (with buffer)
2026-07-15 05:30

legal deadline − 30 min buffer

Earliest submission (30-day window)
2026-06-15

CBP ACE Cargo Release window

On track — submit before the deadlines shown.

Required data fields (17)

  • submitter info
  • transmitter info
  • entry type
  • fda product code
  • common name
  • manufacturer registration number or exemption
  • grower full address
  • shipper
  • owner
  • ultimate consignee
  • carrier
  • mode of transport
  • anticipated arrival port
  • anticipated arrival datetime
  • bill of lading or awb master number
  • country of production
  • country from which shipped

Applicable citations

  • 21 CFR 1.279 (timing)
  • 21 CFR 1.281 (required information)

Sources

  • 21 CFR 1.279 — Timing of Prior Notice submissions (lead-time hours by transport mode).
  • 21 CFR 1.281 — Required information for a Prior Notice submission.
  • 21 CFR 1.277(b) — Exemptions: USDA-exclusive, personal-use accompanied, diplomatic bag.
  • Bioterrorism Act 2002 §307 — Statutory authority for Prior Notice (21 U.S.C. 381(m)).
  • FSMA 2011 IFR (effective 2013-05-30) — Refused-country field requirement and additional data elements.
  • FDA Prior Notice Compliance Policy Guide — Operational guidance for ABI/ACE vs PNSI filing channels.

FDA Prior Notice is an advance, electronic notice to the FDA that must be confirmed before a shipment arrives. It is required for virtually all imported food, animal feed, dietary supplements and beverages (drugs, devices and cosmetics follow the separate FDA Import Entry track). The file-by deadline is set by the transport mode: at least 2 hours before arrival by road, 4 hours by air or rail, 8 hours by water, and before the article is mailed for international post. You file it through CBP's ABI/ACE with the entry, or FDA's free PNSI portal. Miss the window and the food can be refused admission and held at the port under §801(m)(1); Prior Notice is separate from, and on top of, the CBP customs entry.

Primary sources: 21 CFR Part 1 Subpart I · FDA Prior Notice guidance.

Which shipments need it
FDA-regulated food, animal feed, dietary supplements and beverages. USDA-exclusive meat/poultry/egg products, personal-use accompanied food, and diplomatic bags are exempt (21 CFR 1.277(b))
File-by window before arrival
Road 2 h · rail 4 h · air 4 h · water 8 h; international mail before the article is mailed (21 CFR 1.279(a)). FDA must have CONFIRMED the notice by then, not merely received it
Who files it
The submitter or transmitter (typically the importer, customs broker, or filing agent) via ABI/ACE (30-day window) or PNSI (15-day window)
If it is late or missing
The entry can be refused and held under FD&C Act §801(m)(1), even when the food itself is compliant. The violation is the missing notice, not the product

What is FDA Prior Notice?

Since the Bioterrorism Act of 2002, the U.S. Food and Drug Administration must receive advance notice of virtually every shipment of food, animal feed, dietary supplements, and beverages imported or offered for import into the United States. The notice is filed electronically — either through CBP's ABI/ACE system together with the customs entry, or through the FDA Prior Notice System Interface (PNSI). Since the FDA final rule effective October 27, 2025, international mail is no longer restricted to PNSI and may be filed through either system. If an adequate Prior Notice has not been confirmed by the statutory deadline, the shipment can be refused admission and held at the port under section 801(m)(1) of the FD&C Act.

The deadline depends on the mode of transport: at least 2 hours before arrival by road, 4 hours by air or by rail, 8 hours by water, and before the shipment is mailed when it travels by international post. Some categories are exempt — meat, poultry, and egg products under exclusive USDA jurisdiction, food carried by an individual for personal use, and diplomatic-bag shipments. This checker walks through those branching rules for you, computes the exact submit-by datetime in port-local time, and lists the data fields 21 CFR 1.281 requires for your filing channel. The rule table it runs on reflects 21 CFR Part 1 Subpart I as amended by the FSMA interim final rule in force since May 30, 2013, and was last verified against the eCFR on 2026-06-16.

How three shipments resolve

Three patterns through the same rule table the checker runs on (21 CFR 1.279(a) lead-time floors, verified against the eCFR on 2026-06-16). All deadlines are computed in local civil time at the US port of arrival and round earlier — the statutory windows are floors, not targets. Enter your own arrival time, mode and filing channel to compute your submit-by time.

Ocean container of dietary supplements into Los Angeles

Water shipments carry the 8-hour floor of 21 CFR 1.279(a)(3): the Prior Notice must be confirmed at least 8 hours before arrival, and the checker subtracts your safety buffer on top. Filing via ABI/ACE together with the customs entry, the earliest CBP accepts the notice is 30 days before arrival. → compute your submit-by time in the checker above.

Air freight of packaged human food into JFK

Air freight takes the 4-hour floor of 21 CFR 1.279(a)(2): confirmed at least 4 hours before arrival, minus your safety buffer. If the shipper files through FDA's PNSI portal instead of a broker, the earliest-submission window is 15 days rather than 30. → compute your submit-by time in the checker above.

Truck crossing at Laredo just after midnight

Road shipments have the shortest floor — 2 hours under 21 CFR 1.279(a)(1) — and for an arrival just after midnight the deadline can land on the previous calendar day. Date rollover at land borders is one of the most common manual-calculation errors this checker exists to catch. → compute your submit-by time in the checker above.

Edge case: international mail has no clock deadline

For food mailed to the US, 21 CFR 1.279(a)(4) requires the notice to be confirmed before the article is mailed — there is no hour count to subtract from an arrival time. Mail was historically PNSI-only, but since the FDA final rule effective October 27, 2025 it can be filed through either PNSI or ABI/ACE. A mail filing adds two extra data fields to the 21 CFR 1.281 checklist — the tracking number and the anticipated mailing date — and the mail-service name plus tracking number become mandatory for all international mail from October 1, 2026.

How this checker works and where the rules come from

The verdict tree, lead-time floors, and required-fields checklist are implemented directly from 21 CFR Part 1 Subpart I (Prior Notice of Imported Food, §§ 1.276–1.285), the Bioterrorism Act of 2002, and FSMA 2011 § 304. Deadlines are computed in port-local civil time and always round earlier (statutory windows are floors). Every output cites the exact provision it derives from. The dataset is versioned (2026.06.16), operator-verified on 2026-06-16, and flagged stale after 180 days.

This tool does not file a Prior Notice for you and does not cover FDA Import Entry requirements for drugs, devices, or cosmetics. Edge cases (e.g. mixed shipments, transshipment, refused articles) should be confirmed with a licensed customs broker.

FDA Prior Notice — frequently asked questions

How many hours before arrival must FDA Prior Notice be filed?
The statutory floors in 21 CFR 1.279(a) — operator-verified against the eCFR on 2026-06-16 — are 2 hours before arrival by road, 4 hours by air or by rail, and 8 hours by water. For international mail there is no clock-based deadline: the notice must be confirmed before the article is mailed. Note the verb — FDA must have CONFIRMED the notice by the deadline, not merely received it, which is why this checker adds a configurable safety buffer (30 minutes by default) on top of the legal cut-off.
What happens if a Prior Notice is late, inadequate, or missing?
Under section 801(m)(1) of the FD&C Act, food arriving without an adequate, confirmed Prior Notice can be refused admission and held at the port or in secure storage until a valid notice is filed and confirmed. In practice that means demurrage charges, missed delivery windows, and — for repeat offenders — closer FDA and CBP scrutiny of future entries. The refusal applies even when the food itself is perfectly compliant: the violation is the missing notice, not the product. If your arrival window has already passed, this checker flags the shipment as high-risk under §801(m)(1) so you can coordinate with your broker before the goods land.
Do I need Prior Notice for food I carry or mail for personal use?
It depends on how the food travels. Food carried by an individual entering the US for personal consumption — in luggage or hand-carried — is exempt under 21 CFR 1.277(b)(1). The same food MAILED to the US is not exempt: a Prior Notice must be confirmed before the package is sent (through PNSI or, since the October 27, 2025 final rule, ABI/ACE). This asymmetry (accompanied = exempt, mailed = covered) is one of the most frequent misunderstandings around Prior Notice, and the reason the checker asks for both shipment use and mode of transport before issuing a verdict.
What is the difference between filing through ABI/ACE and PNSI?
ABI/ACE is CBP's commercial channel: a customs broker (or self-filer) transmits the Prior Notice together with the entry, and CBP accepts it up to 30 days before arrival. PNSI — the FDA Prior Notice System Interface — is FDA's free web portal and accepts submissions up to 15 days before arrival. International mail was historically PNSI-only, but the FDA final rule effective October 27, 2025 removed that exclusivity, so mailed food can now be filed through either system. The checker switches the earliest-submission window between the two automatically; both figures come from the FDA Prior Notice Compliance Policy Guide and the CBP ACE CATAIR.
Which shipments are exempt from FDA Prior Notice?
Three exemptions in 21 CFR 1.277(b) cover most real cases: meat, poultry, and egg products under exclusive USDA jurisdiction (b)(4)-(6); food carried by an individual for personal use, accompanied (b)(1); and diplomatic-bag shipments (b)(7). The edges matter: meat intended for animal feed and natural casings remain under FDA jurisdiction and DO require Prior Notice, while drugs, devices, and cosmetics are not exempt — they are out of scope entirely and follow the FDA Import Entry track instead.
What information does 21 CFR 1.281 require in a Prior Notice?
The base checklist this tool surfaces holds 17 fields: submitter and transmitter identity, entry type, FDA product code, the article's common name, the manufacturer's registration number (or the reason it is exempt), the grower's full address where known, shipper, owner, ultimate consignee, carrier, mode of transport, anticipated arrival port and datetime, the bill of lading or AWB master number, the country of production, and the country from which shipped. Two conditional fields can extend it: the name of any country that previously refused the article (required by the FSMA interim final rule, in force since May 30, 2013) and, for mailed food filed through PNSI, the tracking number plus the anticipated mailing date.
Do dietary supplements and beverages need Prior Notice?
Yes. Dietary supplements and beverages are food for Bioterrorism Act purposes, so the full Prior Notice regime applies to them: the same lead-time floors and the same 21 CFR 1.281 field checklist. Animal feed, live food animals, meat for animal feed, and natural casings are covered too. When a product sits between categories — a supplement marketed with drug claims, for instance — the checker returns a 'verify scope' verdict rather than guessing, and a licensed customs broker or FDA-compliance consultant should make the final call.

Disclaimer

Results are orientative. They do not constitute legal advice and do not substitute for a licensed customs broker, FDA-compliance consultant, or counsel. Consult a qualified professional before submitting a Prior Notice.

Related import tools

Prior Notice is one step of a US food import. These ShipCost Lab tools cover the steps around it: