On this page
- What Do You Need to Import Food into the USA?
- What Is FDA Prior Notice and When Must You File It?
- How Do Facility Registration and FSVP Work?
- What Labelling and Customs Entry Rules Apply?
- Which US Import Steps Fall to Which Party?
- Why Are Food Shipments Detained or Refused?
- How Do You Source Agro Products from an Indian Exporter for the US?
- Frequently asked questions
FDA prior notice is an advance electronic notice that must reach the US Food and Drug Administration (FDA) before any food shipment arrives in the United States. For ocean freight it must be filed at least 8 hours before the vessel arrives at the port, and the shipment cannot be admitted without it. Prior notice is only one step. To import food into the USA you also need a registered food facility, a Foreign Supplier Verification Program (FSVP), correct labelling and a customs entry. This guide explains each step and who is responsible for it.
Key takeaways
- Prior notice is required by the Bioterrorism Act of 2002 and the rules in 21 CFR Part 1, Subpart I.
- Minimum lead times are 2 hours by road, 4 hours by rail or air and 8 hours by water before arrival.
- Food with no prior notice, or with inaccurate prior notice, is refused admission and held at the port.
- The US importer usually owns the FSVP and the customs entry, but the exporter must supply accurate facility, product and shipment data.
What Do You Need to Import Food into the USA?
To import food into the USA you need five things in place: a registered foreign food facility, a US importer that meets FSVP rules, a valid prior notice for each shipment, labelling that meets FDA rules, and a customs entry filed with US Customs and Border Protection (CBP). FDA does not pre-approve foods; it reviews each entry and may sample or hold the goods.
Most of these duties sit with the US side of the trade, but the data in every filing comes from the exporter. Errors at the origin are a common cause of delays at the US port.
What Is FDA Prior Notice and When Must You File It?
FDA prior notice is a filing that tells FDA what food is coming, who made it, who shipped it and when it will arrive. It became law under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. It applies to food for humans and animals, including bulk pulses, spices and seeds.
The time limits are set in 21 CFR 1.279. Prior notice must be received and confirmed by FDA:
- at least 2 hours before arrival for food arriving by road;
- at least 4 hours before arrival for food arriving by rail or by air;
- at least 8 hours before arrival for food arriving by water;
- before the parcel is sent, for food sent by international mail.
There is also a maximum lead time. A notice filed through CBP’s Automated Commercial Environment (ACE) can be submitted up to 30 calendar days before arrival. A notice filed directly through FDA’s Prior Notice System Interface (PNSI) can be submitted up to 15 calendar days before arrival. Once FDA accepts the notice, the filer receives a prior notice confirmation number.
The notice includes the product identity and FDA product code, the quantity, the manufacturer and its facility registration number, the grower if known, the country of production, the shipper, the importer, owner and consignee, the carrier, the anticipated port and time of arrival, and any country that has refused the same food. Under 21 CFR 1.278, prior notice may be submitted by any person with knowledge of this information.
How Do Facility Registration and FSVP Work?
Any facility that manufactures, processes, packs or holds food for consumption in the USA must register with FDA. This includes foreign facilities, such as an Indian cleaning or packing plant, unless the food is further processed or packed by another foreign facility before export. A foreign facility must name a US agent in its registration. Registrations must be renewed every two years, between 1 October and 31 December of each even-numbered year, so 2026 is a renewal year. Our guide to FDA food facility registration and FSMA covers the process in detail.
The Foreign Supplier Verification Program (FSVP) is a rule under the FDA Food Safety Modernization Act (FSMA). It requires the US importer to verify that each foreign supplier produces food that meets US safety standards. The importer analyses hazards, evaluates the supplier and verifies it through lab reports, audits or sampling. The FSVP importer is the US owner or consignee of the food at entry. If there is none, it is the US agent or representative of the foreign owner. The importer’s FSVP identifier is declared on the customs entry.
The exporter supports FSVP with specifications, lot-wise Certificates of Analysis, residue and microbiological reports, process details and licences; our lab testing page lists the tests we run before loading.
What Labelling and Customs Entry Rules Apply?
Food sold to US consumers must carry an English label that meets FDA rules in 21 CFR Part 101. The core elements are the statement of identity, the net quantity in both metric and US units, an ingredient list, a Nutrition Facts panel (unless exempt), the name and address of the manufacturer, packer or distributor, and an allergen declaration. Sesame became the ninth major food allergen in the USA under the FASTER Act from 1 January 2023; see our note on sesame allergen labelling rules. CBP also requires the country of origin to be marked.
On the customs side, the US importer, usually through a licensed customs broker, files the entry in ACE with a customs bond. For ocean cargo, an Importer Security Filing (ISF, also called 10+2) must be filed with CBP at least 24 hours before the goods are loaded on the vessel abroad. The correct tariff classification matters for duty; you can check the code for each product with our HS code finder.
Which US Import Steps Fall to Which Party?
The US importer or its customs broker files most of the US documents, while the exporter supplies the facility, product and shipment data and the quality documents. The table below shows a typical split of duties for a sea shipment of agro products from India.
| Step | When | Usually done by | What the exporter provides |
|---|---|---|---|
| Food facility registration | Before the first shipment; renew in Oct–Dec of even years | Foreign facility, with its US agent | Registration number of the facility that packs or processes the food |
| FSVP supplier approval | Before the first shipment, then ongoing | US importer (FSVP importer) | Specifications, test reports, process details, licences |
| Importer Security Filing (ISF 10+2) | 24 hours before loading at the foreign port | US importer or broker | Seller, manufacturer, container stuffing location, consolidator |
| FDA prior notice | At least 8 hours before arrival by sea; up to 30 days ahead in ACE | Customs broker or importer | Product details, quantity, lot codes, vessel and arrival data |
| CBP entry and bond | At or before arrival | Licensed customs broker | Commercial invoice, packing list, bill of lading, certificate of origin |
| FDA admissibility review | After entry is filed | FDA | Certificate of Analysis and lab reports if FDA asks |
| Labelling compliance | Before production of retail packs | US brand owner or importer | Correct printing of the agreed label and lot codes |
The Indian export documents, such as the phytosanitary certificate, certificate of origin and shipping bill, are covered in our guide to export documentation.
Why Are Food Shipments Detained or Refused?
Food is most often held at a US port because the paperwork is wrong or because FDA suspects a safety problem. Under 21 CFR 1.283, food that arrives without prior notice, or with inaccurate prior notice, is refused admission and held at the port or in secure storage until the problem is fixed.
Common reasons for detention or refusal include:
- Prior notice problems: no notice, a late notice, or a notice whose product, quantity or facility does not match the shipment.
- Facility registration problems: a missing, expired or incorrect registration number for the manufacturer.
- Contamination: Salmonella in spices and seeds, filth, or insect damage.
- Pesticide residues: residues above US tolerances, or of a pesticide with no US tolerance for that crop.
- Labelling faults: missing allergen statements, missing English labelling, or wrong net quantity.
Most of these risks are prevented at the origin. Test every lot against US limits and keep lot codes on bags and documents identical. A held container also costs demurrage and storage, which you can include in your planning with our landed cost calculator.
Related reading: SFDA Registration and Food Import Requirements for Saudi Arabia and GACC Registration: How to Export Food to China from India.
How Do You Source Agro Products from an Indian Exporter for the US?
Choose an exporter that understands FDA prior notice, FSVP and US residue limits, and that can supply clean, consistent data for every filing. Ask for lot-wise lab reports and sample documents before the first order. Confirm in the contract who files the ISF and the prior notice, and send the exporter your FSVP document list early.
Elysium Agri Corporation exports pulses, chickpeas, sesame, spices, peanuts, psyllium and other agro products from Jamnagar, Gujarat. We hold an Import Export Code, APEDA and Spices Board registrations and an FSSAI Central Licence, all listed on our certificates page. For US buyers, we test each lot against US limits, share facility and shipment data with your broker before arrival, and supply the documents your FSVP file needs.
Tell us the product, grade, quantity and US port, and we will send a quote with the document set for your shipment. Request a US shipment quote →
Frequently asked questions
What is FDA prior notice for food imports?
FDA prior notice is an advance electronic notice telling the US Food and Drug Administration about a food shipment before it arrives. It lists the product, quantity, manufacturer, shipper, importer, carrier and arrival details. It is required for almost all food for humans and animals under the Bioterrorism Act of 2002 and FDA rules in 21 CFR Part 1, Subpart I.
When must prior notice be submitted for food shipped to the US?
FDA must receive and confirm prior notice at least 2 hours before arrival by road, 4 hours by rail or air, and 8 hours by water. For international mail it must be filed before the parcel is sent. A notice filed through CBP's ACE system can be submitted up to 30 days ahead, or up to 15 days ahead through FDA's PNSI.
What are the requirements to import food into the USA?
You need a food facility registered with FDA for the plant that makes or packs the food, a US importer that runs a Foreign Supplier Verification Program, a confirmed prior notice for each shipment, labelling that meets FDA rules, and a customs entry with a bond filed by a broker. Ocean cargo also needs an Importer Security Filing before loading.
Who submits FDA prior notice, the importer or the exporter?
FDA allows any person with knowledge of the required information to submit prior notice. In practice, the US importer's customs broker usually files it in ACE together with the customs entry. The exporter must supply accurate product, quantity, lot, facility registration and shipping details in time, because errors in this data are a common cause of port holds.
What happens if prior notice is missing or incorrect?
Food that arrives without prior notice, or with inaccurate prior notice, is refused admission and held at the port or in secure storage until a valid notice is filed and FDA releases it. The importer pays storage and demurrage during the hold. Repeated or serious violations can also lead to civil penalties or criminal prosecution under US law.
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