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How to import food into the USA: FDA, customs, FSVP and duties explained

Updated

To import food to the USA, two separate systems have to say yes: FDA, which cares about the food, and U.S. Customs and Border Protection (CBP), which cares about the shipment. This guide walks through each step in the order it happens, who is responsible for it, and where first shipments usually go wrong.

This guide is about the mechanics of a food import: the filings, roles and checks between your factory and a released shipment in the U.S. If you are still deciding whether and how to enter the U.S. market at all, start with how to sell food products in the U.S., which covers buyers, channels and strategy. Come back here when you are ready to move goods.

Two systems: FDA and customs

Every food import passes through two gates at the same time.

  • FDA checks that the food can legally enter: the facility that made it is registered, the shipment was announced through Prior Notice, an importer has taken responsibility for supplier verification (FSVP), and the label follows U.S. rules.
  • CBP checks the shipment as merchandise: who the importer of record is, what the goods are, where they come from, what they are worth, and what duties and fees are owed.

The two are connected. Customs entry data is shared with FDA, and FDA can hold a shipment that customs would otherwise release. Passing one gate does not mean you passed the other.

One exception to note first: FDA covers most packaged food, plus pet food, but meat, poultry and certain egg products are regulated by USDA's Food Safety and Inspection Service (FSIS), and alcoholic beverages by the Alcohol and Tobacco Tax and Trade Bureau (TTB). Those products follow different import rules. Everything below assumes an FDA-regulated product.

The steps to import food to the USA, in order

Some steps happen once, before your first shipment. Others repeat with every shipment. Getting the order right is most of the work.

Diagram 1 The food import route, from factory to release
  1. Before production Get ready once Confirm the agency, register the facility, name a U.S. Agent, check the label.
  2. Before booking Assign the roles Choose the importer of record and the FSVP importer, and arrange a bond. Abanro handles customs clearance.
  3. Before loading File ISF Ocean shipments only. Filed before the cargo is loaded abroad.
  4. Before arrival Submit Prior Notice Tells FDA the food is coming, for every shipment and mode.
  5. At arrival Customs entry Entry filed, duties and fees owed, FDA reviews the entry data.
  6. After clearance Release and delivery Goods released, picked up and delivered to the U.S. warehouse.

1. Confirm the agency and product category

Confirm that your product is FDA-regulated, then check whether it falls into a category with extra rules. Low-acid canned foods and acidified foods, for example, have additional FDA registration and process filing requirements that must be in place before they ship.

2. Register the facility and name a U.S. Agent

Facilities that manufacture, process, pack or hold food for U.S. consumption must register with FDA, and a foreign facility must designate a U.S. Agent. Registrations are renewed every two years, between October 1 and December 31 of each even-numbered year (FDA food facility registration). If your registration has lapsed, fix that before you plan a shipment.

3. Check the label before you print

Food sold in the U.S. needs an English label with a Nutrition Facts panel in U.S. format, an ingredient list, major food allergens declared, net quantity in U.S. units (metric may also appear), and the name and place of business of the manufacturer, packer or distributor (FDA food labeling). Label problems are far cheaper to fix in artwork than on a pallet that has already crossed the ocean.

4. Identify the FSVP importer

Under the Foreign Supplier Verification Program, the FSVP importer must verify that its foreign suppliers meet U.S. food safety standards (FDA FSVP rule). The FSVP importer is generally the U.S. owner or consignee at the time of entry. If there is none, a U.S. agent or representative of the foreign owner or consignee must be designated in writing. The FSVP importer must be identified at entry, including a DUNS number. If your brand has no U.S. entity, this is one of the key decisions, and entering the U.S. food market without a U.S. company explains the options.

5. Choose the importer of record, broker and bond

Every import needs an importer of record (IOR), the party legally responsible for the customs entry, and a customs entry itself. A foreign company can usually act as its own IOR, typically through a licensed customs broker. Formal entries need a customs bond, either single-entry or continuous (more on this under duties below).

6. File the ISF for ocean freight

Ocean shipments require an Importer Security Filing, often called ISF or "10+2", filed before the cargo is loaded at the foreign port. It is usually submitted by a customs broker or forwarder on the importer's behalf, so the data (seller, buyer, manufacturer, origin, tariff numbers and more) has to be ready before the container or LCL booking closes. Air and courier shipments do not use ISF.

7. Submit Prior Notice

FDA must receive Prior Notice before each food shipment arrives, for commercial shipments by any mode, including courier and mail (FDA Prior Notice guidance). The confirmation number travels with the shipment. A missing or inaccurate Prior Notice is one of the most avoidable reasons food gets held.

8. File the customs entry and pay duties and fees

When the goods arrive, the entry is filed with CBP, using the commercial invoice, packing list, transport document and product classification. Duties and fees become payable, and FDA reviews the entry data.

9. FDA review, possible exam or sampling

FDA may let the shipment proceed, ask for more information, or hold it for examination or sampling. Some products and origins face more scrutiny than others.

10. Release and delivery

Once both CBP and FDA release the shipment, it can be picked up and delivered. Plan this leg in advance: a warehouse that expects the delivery, has your packing list and can receive and inspect the goods saves time and storage charges at the port or terminal.

Who does each step, and when

Most first-time importers lose time because nobody owns a step. Use this table to assign every line before you book freight.

Food import steps, who is responsible and when each happens
StepWho is usually responsibleWhen
Confirm agency and categoryBrand or exporterBefore product development or export planning
Facility registration and U.S. AgentThe facility owner, with a U.S. Agent it designatesBefore shipping, renewed every two years
Label complianceBrand or exporterBefore printing packaging
FSVP verificationThe FSVP importer (U.S. owner or consignee, or a designated U.S. agent or representative)Before entry, identified at every entry
Importer of record and bondThe IOR, often through its customs brokerBefore the shipment arrives
ISF (ocean only)Importer, usually through a broker or forwarderBefore loading at the foreign port
Prior NoticeOften the customs broker or forwarder, with data from the exporterBefore arrival, every shipment
Customs entry, duties and feesIOR, filed by its licensed customs brokerAt arrival
Responding to an FDA holdImporter and broker, with documents from the exporterAs soon as the hold is issued
Pickup and deliveryForwarder, trucker or U.S. operations partnerAfter release

Abanro handles the customs clearance process for you as part of the same shipment. We can receive the goods at our facility in Orange County, California, near the Ports of Los Angeles and Long Beach, and you, your designated U.S. importer or, in eligible cases, Abanro acts as importer of record.

Duties, fees and the customs bond

What you pay at the border depends on three things.

  • Classification. Every product has a classification in the Harmonized Tariff Schedule of the United States (HTSUS). The classification sets the base duty rate, so a wrong code means a wrong landed cost, and possibly a problem later.
  • Country of origin. The same product can face different duty treatment depending on where it was made. Additional tariffs can apply to certain origins and products, and they change, so check current rates for your exact product before you price it for U.S. buyers.
  • Fees. Merchandise processing fees apply to entries. Your broker's fees and any port or terminal charges are on top.

Formal or informal entry. Commercial shipments valued over $2,500 generally require a formal entry, which needs a customs bond. A single-entry bond covers one shipment; a continuous bond covers all entries over a period and usually makes sense once you import regularly. Shipments at or below $2,500 can generally use an informal entry. Either way, FDA requirements still apply in full.

Treat duty rates as a moving input, not a fixed number. Confirm the rate for your exact product, classification and origin before every price list you send to U.S. buyers. What it costs to test a food product in the U.S. shows where duties sit among the other costs of a first shipment.

Why food shipments get held

A hold is not a verdict. It means FDA or CBP wants to look closer before the goods move. Most holds on first food shipments trace back to a short list of causes.

  • Prior Notice problems: missing, late, or with details that do not match the shipment.
  • Facility registration: the producing facility is not registered, or its registration was not renewed.
  • FSVP importer not identified: no FSVP importer named at entry, or missing details such as the DUNS number.
  • Label issues: no Nutrition Facts panel in U.S. format, undeclared major allergens, missing English, or net quantity without U.S. units.
  • Document mismatches: the invoice, packing list, ISF and Prior Notice describe the goods differently.
  • Product or origin under closer scrutiny: some foods and origins are examined or sampled more often.
  • Category filings missing: for example, required process filings for low-acid canned or acidified foods.
Diagram 2 What can happen after FDA reviews a food entry
FDA reviews the entry data Usually after the customs entry is filed
  • May proceed
    • No further review
    • Customs release can follow
    • Goods move to delivery
  • Held for review
    • Exam, sampling or a request for information
    • Respond fast with complete documents
    • Storage charges keep running
    Many holds resolve when the right documents arrive.
  • Refused admission
    • Issue could not be resolved
    • Goods cannot enter as shipped
    • Options narrow sharply
    Prevention before shipping is far cheaper.

If a shipment is already stuck, speed matters. Shipment Recovery helps when a U.S.-bound shipment is held, refused or stranded. It cannot guarantee a release, but a clear, complete answer gives you the best chance.

What changed for small shipments

For years, many exporters sent samples and small test orders as low-value parcels and expected them to arrive duty-free. That no longer works. The U.S. duty-free de minimis treatment for low-value shipments was suspended for all countries from August 29, 2025, CBP made that suspension indefinite in 2026, and by law it is set to end on July 1, 2027. In practice, small shipments are generally no longer duty-free just because they are low value.

Two things did not change. Small food shipments still need Prior Notice, including by courier and mail. And they still need a customs entry, with duties owed under the HTSUS. If your first move is a few cartons rather than a container, read how to ship your first 100 products to the USA without a container to compare courier, air freight and LCL.

Example: a first pallet of jam

Imagine a family-owned jam producer outside the U.S. sending its first mixed pallet by LCL ocean freight to a California warehouse. It has no U.S. company.

Before production: it confirms jam is FDA-regulated, checks its facility registration is current, and names a U.S. Agent. It redesigns the back label with a U.S. Nutrition Facts panel, allergen declaration, ounces alongside grams, and the producer's name and address.

Before booking: it decides to act as its own importer of record through a customs broker, arranges a single-entry bond because the pallet's value calls for a formal entry, and designates a U.S. representative in writing to act as FSVP importer.

Before loading: the forwarder files the ISF with data the producer supplied. Before arrival: Prior Notice is submitted and the confirmation is shared with everyone involved.

At arrival: the broker files the entry, duties and fees are paid at the rate for the jam's classification and origin, and FDA reviews the entry. Once released, the pallet is trucked to the warehouse, received against the packing list and stored until buyer orders come in.

Nothing in this example is exotic. The difference between a smooth first import and a held one is usually whether each of these steps had an owner before the goods left the factory.

Common mistakes

  1. Printing packaging before the label is checked. Relabeling after arrival is slow and, for compliance problems flagged by FDA, not always possible.
  2. Assuming the broker handles FSVP. Filing the entry and verifying suppliers are different responsibilities. Make sure someone has accepted the FSVP role in writing.
  3. Letting registration lapse. A renewal missed in an even-numbered year can stop shipments that were planned months earlier.
  4. Pricing with last year's duty rate. Additional tariffs change. Check before every price list.
  5. Sending samples as gifts or low-value parcels. Commercial samples still need Prior Notice, and de minimis is no longer a shortcut.
  6. No plan after release. Goods sitting at a terminal accumulate charges. Book delivery and storage before the ship arrives.
  7. Mismatched documents. The same product described three ways across the invoice, ISF and Prior Notice invites questions.

Plan your first food import

Before you book freight, write down the owner of every step in the table above: who registers, who checks the label, who is the importer of record, who is the FSVP importer, who files ISF and Prior Notice, and where the goods go after release. If any line is blank, that is where your shipment is most likely to stop.

Abanro works with international sellers on exactly this handoff. Abanro handles the customs clearance process for you as part of the same shipment. We then receive, store and prepare food at our California facility through food product prep, including carton and barcode labeling for the next leg. Specialized regulatory work, such as facility registration, U.S. Agent services and FSVP, is handled by specialized third parties, and we can help you identify what you need.

Tell us what you are shipping, from where, and by which mode.

Get a U.S. customs clearance quote

This guide is general information, not legal or regulatory advice. Requirements depend on your product, origin and shipment, and duties, taxes and government charges are paid at actual cost. The brand, its designated U.S. importer or, in eligible cases, Abanro acts as importer of record, and Abanro does not guarantee clearance or release.

Questions

Do I need FDA approval to import food into the USA?

Most foods do not need FDA approval before import. They need to comply: the producing facility is registered with FDA, Prior Notice is submitted for each shipment, an FSVP importer is identified at entry, and the label meets U.S. rules. Some categories, such as low-acid canned and acidified foods, have additional FDA registration and process filing requirements.

Can a foreign company import food into the U.S. without a U.S. company?

Usually, yes. A foreign company can generally act as its own importer of record, typically through a licensed customs broker, and will need a customs bond for formal entries. The FSVP role has its own rules: if there is no U.S. owner or consignee at entry, a U.S. agent or representative must be designated in writing to act as FSVP importer.

Is Prior Notice needed if I send food samples by courier?

Yes. FDA requires Prior Notice before food shipments arrive, for commercial shipments by any mode, including courier and mail. Customs entry rules also still apply to the shipment.

How do I find the duty rate for my food product?

The duty rate depends on how the product is classified in the Harmonized Tariff Schedule of the United States (HTSUS) and on its country of origin. Additional tariffs can apply and change, so confirm the current rate for your exact product and origin with your customs broker before you set U.S. prices.

What happens if FDA holds my shipment?

FDA may examine or sample the goods, or ask for more information. Depending on the finding, the shipment may then be released, or it may be refused admission if the issue cannot be resolved. Storage charges usually keep running while goods are held, so a fast, complete response matters.

Who handles customs clearance?

Abanro handles U.S. customs clearance as part of your shipment. The brand, its designated U.S. importer or, in eligible cases, Abanro acts as importer of record, and duties, taxes and government charges are billed separately at actual cost.

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