How to export food products to the USA: FDA registration, FSVP, labeling and prior notice (2026 guide)

Two federal agencies handle most food imports. The Food and Drug Administration (FDA) sets the safety and labeling rules for most foods and reviews import information to decide which shipments to examine or sample on arrival. U.S. Customs and Border Protection (CBP) handles the entry itself: the importer of record, the customs bond, classification and duties. Meat, poultry and egg products fall mainly under the U.S. Department of Agriculture and are not covered here.

For most foods there is no single approval to apply for. FDA does not pre-approve food labels, and CBP does not require an import license, although other agencies may require permits for some products. Instead, registrations, notifications and records must be in place before the goods arrive. For most packaged foods and ingredients, the work falls into six steps:

1. Register the facility with FDA, and renew it on time
2. Appoint a US agent for the foreign facility
3. Agree who will act as the FSVP importer
4. Make the label US-compliant
5. Submit prior notice for every shipment
6. Clear CBP entry with an importer of record and a customs bond

Some categories carry extra rules, for example low-acid canned and acidified foods, seafood and juice. If your product is in one of them, plan for additional filings.

Domestic and foreign facilities that manufacture, process, pack or hold food for consumption in the United States must register with FDA, unless an exemption applies. For an exporter, that usually means the factory that makes or packs the product, and possibly the warehouse that holds it before export.

If one foreign facility sends food to another for further manufacturing or processing, including packaging, FDA's guidance says that, generally, only the second facility needs to register for that food. That changes if the second facility only adds a label or does something similarly minor: then the first facility must register too. Farms, restaurants, retail food establishments and facilities regulated exclusively by USDA are among the operations that don't have to register.

What to know about registration:

• It is electronic and free. Facilities register through an FDA Industry Systems (FIS) account, with no fee for registration or renewal.
• It needs a unique facility identifier. FDA currently recognizes the DUNS number, and checks that its address matches the registered facility address.
• It must be renewed every two years, between October 1 and December 31 of each even-numbered year.

2026 is a renewal year. FDA has said it will consider the registration expired for any facility that fails to renew by December 31, 2026. If you already ship to the US, check your status in FIS now. Keep the registration current: prior notice for most processed foods asks for the manufacturer's registration number.

Every foreign facility registered with FDA must designate a US agent who lives or maintains a place of business in the United States and is physically present there. The agent is the communications link between your facility and FDA, and may also be authorized to register the facility for you.

The US agent doesn't have to be your importer or distributor, but it should respond quickly when FDA gets in touch. FDA's U.S. Agent Voluntary Identification System (VIS) lets agents identify the facilities they represent.

The Foreign Supplier Verification Programs (FSVP) rule, issued under the FDA Food Safety Modernization Act (FSMA), makes a US party responsible for verifying the foreign suppliers of imported food. FDA defines the FSVP importer as the US owner or consignee of the food at the time of entry. If there is none, it is the US agent or representative of the foreign owner or consignee, confirmed in a signed statement of consent.

For most foods, the FSVP importer must:

• Identify the known or reasonably foreseeable hazards in each food
• Evaluate the risk posed by the food and the foreign supplier's performance
• Approve suppliers and decide how to verify them, for example through on-site audits, sampling and testing, or review of food safety records
• Take prompt corrective action if a supplier falls short
• Keep an FSVP for each food from each foreign supplier, and reevaluate it at least every three years

At entry, the FSVP importer's name, email address and unique facility identifier (currently a DUNS number) must be provided for each line of food. Some foods are exempt or partly exempt, including juice and seafood covered by FDA's HACCP rules and certain alcoholic beverages. Very small importers, and importers of food from certain small suppliers, have modified requirements.

For an exporter, FSVP matters in two ways. First, your US buyer will usually ask for documents to support its program: specifications, your food safety plan, audit reports and certificates of analysis. A certificate under a recognized scheme such as BRCGS, IFS or FSSC 22000 helps, but it doesn't replace the importer's FSVP. Second, if you ship before you have a US buyer, someone in the United States still has to take the FSVP importer role. Agree who, in writing, before the first shipment.

A label designed for Europe rarely works in the United States as it is. FDA's Food Labeling Guide sets out where each statement goes:

• Principal display panel (front): the statement of identity (the common or usual name of the food) and the net quantity of contents. The net quantity generally goes in the bottom 30 percent of the panel and is stated in both metric and US customary units, for example "Net wt 8 oz (227 g)".
• Information panel: the name and place of business of the manufacturer, packer or distributor, the ingredient list, the Nutrition Facts label and any required allergen labeling, with no unrelated material in between. If the company named is not the manufacturer, add a qualifier such as "Distributed by".
• Language: if any foreign language appears on the label, all required statements must appear in English and in that language.
• Country of origin: a CBP marking rule rather than an FDA one. It must be conspicuous and, where the label shows a US name or address, generally placed close to it.

Nutrition Facts. The updated format has been mandatory since 2020 for larger manufacturers and 2021 for smaller ones. It declares added sugars, uses serving sizes based on what people actually eat, and for some package sizes needs "per serving" and "per package" columns. Single-ingredient sugars such as pure honey don't have to declare the gram amount of added sugars, but they still show the percent Daily Value for added sugars. Foods with insignificant amounts of all required nutrients, such as plain coffee, tea and spices, can be exempt if the label makes no nutrition claims.

Allergens. US law recognizes nine major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame became the ninth on January 1, 2023, under the FASTER Act. The label must name the specific tree nut (for example almonds or walnuts) and the species of fish or crustacean shellfish, either within the ingredient list or in a "Contains" statement immediately after or next to it. The EU and UK use a different list of 14 allergens and different presentation rules, so a European allergen panel can't simply be copied.

Claims. Nutrient content claims such as "sugar free", "high in fiber" or "light" have defined meanings in FDA rules, and health-related claims are restricted. Review every claim before you print.

FDA must receive prior notice of all food for humans and animals imported or offered for import into the United States, unless an exemption applies.

• Who files: anyone with knowledge of the shipment, including the importer, a customs broker, the manufacturer, the exporter or the US agent. Often the customs broker files it together with the entry.
• How: through CBP's Automated Broker Interface and ACE, or through FDA's Prior Notice System Interface (PNSI).

Timing depends on how the food arrives:

Prior notice can't be submitted more than 30 calendar days before arrival through ACE, or 15 calendar days through PNSI. Food that arrives with inadequate prior notice is subject to refusal and, if refused, is held at the port or another secure location until the problem is resolved.

Commercial samples sent to US buyers generally need prior notice too. For food sent by international mail, a final rule FDA issued in September 2025 requires prior notice to include the name of the mail service and the mail tracking number.

• An importer of record: the owner or purchaser of the goods, or a licensed customs broker designated by them. The importer of record is responsible for the accuracy of the entry and for duties, taxes and fees, even when a broker files.
• An importer number: the importer's IRS business number, or a CBP-assigned number requested on CBP Form 5106.
• A customs bond: CBP requires one for commercial imports above a set value and for goods subject to other federal agencies' requirements, which include most food. Plan for a single-entry or continuous bond, arranged through a surety, on every commercial food shipment.
• Importer Security Filing (ISF, "10+2"): for ocean shipments, advance cargo information sent electronically to CBP by the ISF importer or its agent, generally at least 24 hours before the cargo is loaded at the foreign port.
• Entry and entry summary: entry documents within 15 calendar days of arrival, then the entry summary (CBP Form 7501) and estimated duties within 10 working days.
• Classification and duty: the rate depends on the product's Harmonized Tariff Schedule classification and origin. Rates and additional duties can change, so confirm them with your customs broker for each shipment.
• Examinations: CBP may examine any shipment, and the importer bears the cost of making the goods available. FDA can also examine or sample food at entry.

• Facility registration active and renewed for 2026, with a DUNS number that matches the registered address
• US agent appointed and reachable
• FSVP importer agreed in writing, with your supplier documents ready
• US label checked before printing: identity, net quantity, ingredients, Nutrition Facts, allergens, origin and claims, rather than relabeling after arrival
• Customs broker appointed, with importer of record, bond and ISF confirmed
• Duty, bond, brokerage and warehousing built into the landed cost, not just the ex-works price
• Prior notice timing in the shipping plan, including for samples

Union Trade helps food and beverage producers prepare for the US market. We help you check labels and claims against US requirements, agree who holds each role (US agent, FSVP importer, importer of record), build the landed cost and approach US importers, distributors and buyers. We work alongside licensed customs brokers and regulatory consultants: we coordinate, they file and advise. See US market entry & import readiness, or tell us about your brand.

This guide is general information, not legal advice. Rules change, so check the official sources below before you ship.