FDA Prior Notice Filing Service for Imported Food
Every shipment of imported human or animal food needs an FDA Prior Notice before it arrives, unless an exemption applies. A missing or wrong Prior Notice means the food is refused and held at the port. We check your shipment details, file through FDA's Prior Notice System Interface (PNSI) within the deadline and send you the confirmation number for $35 per filing.
Shipment coming soon? Send the product details, manufacturer, port and arrival date. We file your Prior Notice and send the confirmation, $35 per filing.
Request Prior Notice FilingPrior Notice Deadlines by Transport Mode
| Transport mode | Minimum time before arrival | Notes |
|---|---|---|
| Road (truck) | 2 hours | Land crossings from Canada and Mexico |
| Rail | 4 hours | Land arrival by train |
| Air | 4 hours | Air cargo and courier shipments |
| Water | 8 hours | Ocean and other vessel shipments |
| International mail | Before the food is sent | Mail service and tracking number added by the 2025 rule |
| Carried by a traveler | Per mode of arrival | Unless it is for personal use |
Deadlines are in 21 CFR 1.279. Through PNSI, you can generally file up to 15 days before arrival; through ACE, up to 30 days.
Who Must File and What Is Exempt
Covered
Human food, animal food and pet food, ingredients, dietary supplements, beverages, and commercial and market-research samples.
Exempt
Personal-use food carried by travelers, homemade personal gifts, food exported without leaving the port, USDA-only meat, poultry and egg products, and diplomatic bags (21 CFR 1.277).
Who can file
Anyone with knowledge of the information: manufacturer, exporter, importer, broker or U.S. Agent. We file for all of them.
What a Prior Notice Includes
Required elements are in 21 CFR 1.281.
If Prior Notice Is Missing or Wrong
Food with no Prior Notice, a late one or inaccurate information is subject to refusal and is held at the port or a secure facility (21 CFR 1.283). Under FDA's 2025 final rule, effective October 27, 2025, a corrected Prior Notice must generally be submitted within 10 calendar days of the refusal notice. If a food facility registration problem causes a hold, a valid registration must be provided within 30 days. If deadlines are missed, the food is treated as general order merchandise and can generally only be exported or destroyed.
We help file the corrected Prior Notice and fix registration problems. See releasing an FDA-held shipment and import refusal prevention.
How We File Your Prior Notice
Confirmation means the filing is complete. It is not FDA approval of the food or the shipment.
Prior Notice Filing Cost
| Item | Price |
|---|---|
| Prior Notice filing, per food article | $35 |
| FDA government fee for Prior Notice | None |
| Recurring or high-volume filings | Quoted on request |
See our full price list.
Other Import Requirements
Registration
The manufacturer must be registered. See foreign food facility registration, domestic food facility registration and registration renewal.
Importer duties
The U.S. importer needs FSVP, and foreign facilities need U.S. Agent services.
Learn more
Read our Prior Notice explained guide for a step-by-step explanation.
File Your FDA Prior Notice
Send us your shipment details. We check them, file through PNSI within the deadline and send the confirmation number.
- $35 per filing; FDA charges no fee.
- Human food, animal food, supplements and beverages.
- Road, rail, air, water and international mail.
Contact our specialists, email info@fdaregistrationassistance.com, or call +1 (928) 275-8333. Pricing · FDA food services.
Request Prior Notice FilingFDA Registration Assistance is a private consulting firm, not FDA or any government agency. FDA registration is not FDA approval, clearance or certification.
Frequently Asked Questions — FDA Prior Notice
What is FDA Prior Notice?
FDA Prior Notice is an advance electronic notice to FDA about human or animal food that is imported or offered for import into the United States. It is required unless an exemption applies (21 CFR Part 1, Subpart I). FDA, working with CBP, uses it to review shipments and target inspections before the food arrives. We prepare and file Prior Notices for importers, exporters, manufacturers and brokers.
Who is responsible for filing Prior Notice?
Any person with knowledge of the required information can submit Prior Notice. That includes the manufacturer, exporter, importer, customs broker or U.S. Agent. The submitter and the transmitter can be different parties. We prepare and transmit the filing using the shipment and facility details you send us.
When must Prior Notice be submitted?
FDA must receive and confirm Prior Notice at least 2 hours before arrival by road, 4 hours by rail, 4 hours by air and 8 hours by water (21 CFR 1.279). For international mail, it must be submitted before the food is sent. Through PNSI, you can generally file no more than 15 calendar days before arrival; through CBP's ACE, no more than 30 days.
What happens if Prior Notice is not filed?
Food with no Prior Notice or an inadequate one is subject to refusal and is held at the port or another secure location unless FDA or CBP directs otherwise (21 CFR 1.283). Holds create storage, demurrage and delay costs. Under the 2025 final rule, a corrected Prior Notice must generally be submitted within 10 calendar days of the refusal notice, or the food can be exported or destroyed.
Does Prior Notice apply to animal feed?
Yes. Prior Notice applies to food for humans and other animals, including pet food, animal feed, ingredients, dietary supplements and beverages, unless an exemption applies. Meat, poultry and egg products under USDA's exclusive jurisdiction are among the exemptions.
What information must a Prior Notice include?
It depends on the entry type and transport mode, but a Prior Notice usually includes the submitter and transmitter, the FDA product code, the common or usual name, quantity, manufacturer and its food facility registration number, FDA country of production, shipper, importer or owner, consignee, port of arrival, carrier and arrival details (21 CFR 1.281). Grower information is needed for some food in its natural state.
Can FDA Registration Assistance file on my behalf?
Yes. We review your shipment information, prepare the Prior Notice, transmit it through FDA's Prior Notice System Interface (PNSI) and send you the confirmation number and confirmation page. You do not need your own PNSI account to use our service.
Is a separate Prior Notice required per shipment?
Prior Notice is filed for each article of food in an entry. A single shipment with several different products, sizes or manufacturers may need several Prior Notices. We organize multi-product and recurring filings so every food article is covered.
What is the FDA Prior Notice System Interface (PNSI)?
PNSI is FDA's online system for submitting Prior Notice directly to FDA. Prior Notice can also be sent through CBP's Automated Commercial Environment (ACE), which most customs brokers use. FDA's help desk handles PNSI account and password questions (FDA Prior Notice page). We file through PNSI for our clients.
What is the cost of Prior Notice filing?
Our fee is $35 per Prior Notice filing. It covers preparation, review, PNSI submission and delivery of the FDA confirmation. FDA charges no government fee for Prior Notice. Because each food article needs its own Prior Notice, a mixed shipment can need several filings. Ask us about recurring or high-volume pricing.
Does Prior Notice apply to mail shipments?
Yes. Food sent by international mail needs Prior Notice unless an exemption applies, and it must be filed before the food is sent. The 2025 final rule adds the mail service name and tracking number to mail Prior Notices starting October 1, 2026. FDA has said it does not expect these two items until May 1, 2027, while systems are updated (FDA Prior Notice page).
Can Prior Notices be amended or cancelled?
After FDA confirms a Prior Notice, the confirmed information generally cannot be changed. If information that requires a new Prior Notice changes, you submit a new one, and FDA recommends cancelling the old one first. Some details, such as the anticipated arrival time and port, can be updated before arrival. We review the change and prepare the replacement filing.
How far in advance should I contact you before my shipment?
Contact us as early as possible, ideally 24 to 48 hours before the filing deadline. That gives us time to check the details, fix discrepancies such as an expired facility registration, and file well within FDA's timeframes. Rush filings are possible when the details are complete.
Does my shipment size or value affect Prior Notice requirements?
No. Prior Notice does not depend on shipment size or value. Commercial samples and market-research samples generally need Prior Notice. Exemptions are specific: food carried by an individual for personal use, certain homemade personal gifts, food exported without leaving the port, certain USDA-regulated products and food in diplomatic bags.
What happens after Prior Notice is accepted by the FDA?
FDA issues a confirmation number when it receives a facially complete Prior Notice. That number is not an FDA approval of the food or the shipment, and FDA can still examine, sample or hold the food. The confirmation should travel with the shipment or be available to the carrier, and specific rules apply to PNSI commercial filings, mail and food carried by travelers.
Can you handle high-volume or recurring Prior Notice filings?
Yes. We manage Prior Notice filings for importers with frequent or high-volume shipments. We keep your product codes, manufacturers and registration numbers on file so each new filing is quick and consistent, and we flag registrations that are close to expiring.
What food imports are exempt from FDA Prior Notice?
The exemptions in 21 CFR 1.277 include food carried by an individual for personal use, food made in a personal residence and sent as a personal gift, food exported without leaving the port of arrival, meat, poultry and egg products under USDA's exclusive jurisdiction, and food in diplomatic bags. Most commercial shipments, including samples, are not exempt.
How early can FDA Prior Notice be filed?
Except for international mail, Prior Notice can generally be filed no more than 15 calendar days before anticipated arrival through PNSI, or no more than 30 calendar days through CBP's ACE. The minimum lead time still depends on the transport mode.
Is Prior Notice the same as FSVP or FDA Food Facility Registration?
No. Prior Notice is a shipment-level notice for each food article. Food facility registration applies to facilities that make, process, pack or hold food for U.S. consumption (foreign food facility registration). FSVP places supplier-verification duties on the U.S. importer (FSVP). A single import usually involves all three, and Prior Notice must list the manufacturer's registration number.
What is the 10-day rule after an FDA Prior Notice refusal?
Under FDA's 2025 final rule, effective October 27, 2025, when food is refused for inadequate Prior Notice, the required Prior Notice must be submitted or resubmitted within 10 calendar days of the refusal notice, or within 10 days of FDA's response if you asked for FDA review. If it is not done in time, the food is treated as general order merchandise and can generally only be exported or destroyed.
Request Prior Notice Filing
Tell us what your company makes, sells, or distributes, where each product is manufactured or packed, your U.S. importer or buyer arrangement, label readiness, and target shipment date.
Submitting this inquiry does not purchase a service or authorize paid work. Our team can discuss the scope and required materials before you commission assistance. Fields marked with an asterisk are required.