Scope and exemptions
Prior Notice informs FDA about each applicable food article imported or offered for import, including human and animal food, commercial samples and many gifts. It is not one permanent filing for an exporter or necessarily one notice per container. Exceptions include personal-use food accompanying a traveller, homemade personal gifts sent by their maker, food exported without leaving the arrival port, products under exclusive USDA meat/poultry/egg jurisdiction and diplomatic bags. Check the actual conditions; a commercial courier parcel is not automatically exempt.
Who may submit or transmit?
A person who knows the required information may submit. They may use another person to transmit it, or do both themselves. An importer, broker, exporter or US Agent can act when appropriately informed; the US Agent role does not automatically include paid filing or FSVP importer responsibilities.
Information for each food article
Prepare the FDA product code, food name, estimated quantity and required lot codes; production and shipping countries; shipper, importer, owner and ultimate consignee as applicable; carrier, entry and arrival details. Identify the manufacturer of processed food using its name plus registration number, city and country, or full address and the truthful reason the number is not provided. For food in its natural state, identify the grower and growing location if known; the consolidator alternative applies when the grower is unknown. Never invent a number or exemption.
Registration and identifiers
Food facility registration, including applicable biennial renewal, is separate from Prior Notice. An FFR number is not DUNS/UFI, FEI or a PN confirmation number. FEI lookup does not prove valid food registration. An allowed reason for omitting a registration number does not waive a facility's registration duty. PN does not replace FSVP, food safety or labelling obligations.
When must FDA confirm the notice?
Under 21 CFR 1.279, submit and obtain FDA confirmation for review at least 2 hours before arrival by road, 4 by rail, 4 by air and 8 by water at the US port of arrival. Except international mail, file no more than 15 calendar days before arrival through PNSI or 30 through ABI/ACE. These are maximum advance windows, not minimum waiting periods of 15 or 30 days. Plan sufficient processing time.
International mail and express couriers
International mail requires Prior Notice before dispatch. Private express courier service is not automatically international mail; apply the actual transport requirements. FDA's limited enforcement delay until May 1, 2027 concerns the mail-service name and tracking-number fields only. It does not suspend ordinary Prior Notice or the before-dispatch rule.
Changes after confirmation
Under 21 CFR 1.282, changed required information generally requires resubmission and cancellation of the old notice through the original system. For non-mail shipments, quantity, anticipated arrival and planned shipment details are specified exceptions; for mail, the rule excepts the anticipated mailing date. Check the precise provision and timing before proceeding; not every change needs a new notice, and the exceptions do not excuse a late arrival notification.
What does the confirmation number mean?
FDA confirmation acknowledges receipt for review, not accuracy, approval or guaranteed admission. For PNSI, the number must accompany the food and be provided on arrival; international-mail parcels need it on the customs declaration. Applicable food accompanying a person needs a copy of the confirmation. ABI/ACE shipments generally need no extra PN document except those mail/person cases; retain the reference for coordination.
Missing, late or inadequate notice
Food without adequate, timely notice is subject to refusal and holding under 21 CFR 1.283. Follow FDA/CBP instructions for the actual case; correction alone does not guarantee release, re-export or any particular outcome. Do not move held food without authorization. Delays can create storage costs and spoilage risk.
Common mistakes to avoid
Do not reuse a notice for new food articles, confuse FEI with FFR, use the obsolete five-day maximum, reverse the before-arrival deadlines, lose the confirmation reference or assume confirmation clears the goods. Recheck transport, manufacturer information and applicable exemptions for each filing.
Professional service and fee
FDA does not charge for PNSI submission. FDABridge's professional fee is US$99 per shipment, subject to an agreed scope. A shipment can require several food-article notices; confirm the articles and scope in the quotation. This is not an FDA fee or an import-clearance guarantee. Registration, US Agent and FSVP services are separate unless expressly agreed.
How the service proceeds
Send product, manufacturer/grower and shipment details for review; agree the scope and operational intake cutoff, then arrange filing and receive the confirmation reference. Any professional intake cutoff is separate from the legal deadline. An enquiry acknowledgement is not payment, filing, FDA completion or permission to import.
Common questions
Who may submit or transmit?
A person who knows the required information may submit. They may use another person to transmit it, or do both themselves. An importer, broker, exporter or US Agent can act when appropriately informed; the US Agent role does not automatically include paid filing or FSVP importer responsibilities.
When must FDA confirm the notice?
Under 21 CFR 1.279, submit and obtain FDA confirmation for review at least 2 hours before arrival by road, 4 by rail, 4 by air and 8 by water at the US port of arrival. Except international mail, file no more than 15 calendar days before arrival through PNSI or 30 through ABI/ACE. These are maximum advance windows, not minimum waiting periods of 15 or 30 days. Plan sufficient processing time.
What does the confirmation number mean?
FDA confirmation acknowledges receipt for review, not accuracy, approval or guaranteed admission. For PNSI, the number must accompany the food and be provided on arrival; international-mail parcels need it on the customs declaration. Applicable food accompanying a person needs a copy of the confirmation. ABI/ACE shipments generally need no extra PN document except those mail/person cases; retain the reference for coordination.
Related Articles
FDA Registration Numbers Explained: Check Your Filing Record — https://fdabridge.com/blog/fda-registration-numbers-explained-fei-duns-and-facility-identification
What Is a US FDA Agent for a Foreign Food Facility? — https://fdabridge.com/blog/what-is-a-us-fda-agent-and-why-every-foreign-food-facility-must-have-one
https://fdabridge.com/prior-notice
https://fdabridge.com/contact?service=prior-notice
FDA / 21 CFR
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-I/section-1.277
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-I/section-1.278
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-I/section-1.279
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-I/section-1.281
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-I/section-1.282
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-I/section-1.283
FDA Prior Notice: filing windows, food articles and confirmation
Understand FDA Prior Notice deadlines, exemptions, shipment information and confirmation handling. PNSI allows up to 15 days; ABI/ACE up to 30 days before arrival.