Selling Food Into the US: What Exporters Need to Get Right

Last reviewed: July 2026. US import rules change frequently — see "Verify before you ship" at the end of this guide.

Most guides to US food import rules are written for US importers. This one is written for you — the exporter or supplier shipping food into the United States from abroad. That distinction matters more than it sounds, because the single most useful thing to understand about US food regulation is this: for much of it, you are not the legally regulated party. Your US buyer is. But almost every obligation that lands on them converts into a demand on you — for documents, for registration numbers, for verification records. Suppliers who understand that conversion win business. Suppliers who don't get quietly dropped, usually without being told why.

Three gates, not one

Three questions get collapsed into one, and they are not the same. A consignment can clear the first and fail the second; a product can satisfy both and still lose the order at the third.

1. Entry — can the goods lawfully arrive? FDA registration, Prior Notice, CBP entry, FSIS country and establishment eligibility, APHIS requirements, permits and certificates.
2. Sale — can the product lawfully be sold once inside? Classification, labelling, allergens, Nutrition Facts, ingredients and additives, claims, organic and bioengineered disclosure, product-specific rules.
3. Buyer acceptance — will a US buyer actually take it? FSVP documentation, supplier approval, audits, COAs, traceability, specifications and certifications — most of which go beyond the statutory minimum.

A note on wording throughout this guide: where something is required by US law we say so plainly; where it is something US buyers commonly demand but the law does not require, we say that too. Confusing the two is how exporters either over-invest in certificates nobody asked for, or lose a deal to a requirement they assumed was optional.

The four gatekeepers, and which one governs your product

Four US agencies stand between your product and a US warehouse. Knowing which one governs you is step one — the requirements barely overlap.

Category-specific regulators can also apply. USDA's Agricultural Marketing Service (AMS) administers the National Organic Program and the National Bioengineered Food Disclosure Standard; the Alcohol and Tobacco Tax and Trade Bureau (TTB) applies to alcoholic beverages. These are not universal border agencies, but they can decide whether your particular product is saleable.

The FSIS distinction is the one that surprises people. For FDA-regulated food, you register and ship. For meat and poultry, the US must first determine that your entire national inspection system is "equivalent" to its own, then approve your specific establishment. There is no workaround, no paperwork substitute, and no amount of buyer enthusiasm that overcomes it. If you produce meat or poultry in a country without equivalence status, you cannot lawfully export the relevant FSIS-regulated product to the US until that country becomes eligible — a government-to-government matter, not something a supplier can resolve.

Before registration: classify the product

The first question is not which registration you need. It is which regulatory category your product sits in — because that decides everything downstream.

A product that looks like ordinary packaged food may in fact be treated as a dietary supplement, a beverage, an infant formula, a medical food, a food containing an unapproved additive or colour additive, a seafood or juice product under its own HACCP regime, an acidified or low-acid canned food requiring separate establishment registration and filed scheduled processes, an alcoholic beverage, or animal food. Each carries different registration, documentation and labelling obligations.

Alcoholic beverages are a particular trap. FDA requirements may still apply, but the product can also fall under the Alcohol and Tobacco Tax and Trade Bureau (TTB), with its own permits, labelling approval and formula requirements depending on the product. If you export wine, beer or spirits, TTB is a separate workstream, not a footnote to FDA compliance.

Get classification wrong and you build the wrong compliance file — usually discovering it at the port, which is the most expensive place to learn.

FDA Food Facility Registration — and the 2026 renewal window you cannot miss

If your facility manufactures, processes, packs, or holds food destined for US consumption, and is not covered by an applicable registration exemption, it must be registered with FDA. This applies to foreign facilities exactly as it applies to domestic ones. Registration is free. Failing to hold one is not a technicality: food from an unregistered facility is legally adulterated and cannot lawfully enter the United States.

What registration requires

• FDA currently recognizes the Dun & Bradstreet DUNS number as the acceptable Unique Facility Identifier (UFI) for food facility registration. FDA will not confirm a registration or renewal until it has verified the UFI against the facility's address. The DUNS must correspond to the actual registered facility location — not a corporate headquarters.
• A US Agent. Every foreign facility must designate a US Agent who is physically in the United States and available during US business hours. The agent is FDA's point of contact for you — including for inspection notices and emergencies. Note that the US Agent for facility registration and the FSVP importer are different legal roles. They may be the same organisation in some supply chains, but they are not interchangeable.
• Registration of the correct facility. Register the plant that actually makes the food, not the corporate headquarters or the trading arm. A frequent practical error is registering the corporate headquarters rather than the facility that actually manufactures or handles the food.

The renewal trap — and why 2026 matters right now

Registration is not permanent. It must be renewed every two years, during a window that runs from October 1 to December 31 of every even-numbered year. 2026 is a renewal year. The window opens October 1, 2026 and closes at 11:59 PM on December 31, 2026.

There is no grace period. If you do not renew inside that window, FDA considers the registration expired and removes it from the system. Subsequent Prior Notice filings and import entries may fail because the facility registration cannot be validated, and shipments can be refused at the port. It does not matter when you first registered — a facility that registers on September 30, 2026 must still renew between October 1 and December 31, 2026.

Two practical points. A biennial renewal cannot be completed outside the renewal window — but registration information can and should be kept updated throughout the year; updating and renewing are different functions. And renewal is the right moment to confirm your US Agent is still willing to act and your DUNS details are still accurate, because a stale agent designation surfaces at the worst possible time.

Prior Notice — your buyer may file it, but you supply what makes it work

Before any food shipment arrives in the US, FDA must receive advance electronic notice of it. Under 21 CFR 1.278 a prior notice may be submitted by any person with knowledge of the required information, and FDA applies no geographic restriction to the submitter — so you can file it yourself through FDA's Prior Notice System Interface (PNSI). In practice the US importer or their customs broker usually transmits it, but the submission is built almost entirely from information only you can supply. But the filing is built almost entirely from information only you can supply, and a bad filing kills the shipment. FDA distinguishes the submitter (responsible for the information) from the transmitter (who sends it). Knowing you can be the submitter is useful leverage when a broker is slow.

The timing windows (21 CFR 1.279)

There are also outer limits: filings made through CBP's ABI/ACE/ITDS may not be submitted more than 30 calendar days before anticipated arrival; filings through FDA's own Prior Notice System Interface (PNSI) may not be submitted more than 15 calendar days before. Note that the clock starts when FDA confirms the submission for review, not when it is sent.

Where exporters break Prior Notice

• Supplying stale or lapsed facility information. FDA validates the manufacturer/producer information in a Prior Notice against its records. A mismatch between the actual producing facility and what was submitted — including a registration that has lapsed because the biennial renewal was missed — can trigger delays or holds. This is why the two sections of this guide connect.
• Naming the wrong manufacturer. Prior Notice requires the actual facility that produced, processed, or packed the food — not the exporter, trading company, or broker who arranged the sale. If you are a trading intermediary, you must supply the producing facility's details, not your own.
• Giving your buyer the information late. A 2-hour road window is unforgiving. If your broker is chasing you for a registration number while the truck is moving, you have already created a problem.
• Changing details after confirmation. Once FDA has confirmed a Prior Notice, it cannot be amended — a new one must be submitted. Certain changes after confirmation require a new prior notice, which restarts the applicable clock. Some changes — such as estimated quantity or anticipated arrival — may be treated differently, so check FDA's current rules before assuming a new filing is needed.

FSVP — your buyer's legal obligation, your document burden

The Foreign Supplier Verification Program is the rule most misunderstood by exporters, and the one that most often explains why a promising deal goes quiet.

Under FSVP, the US importer — defined as the US owner or consignee of the food at the time of entry — must verify that you, their foreign supplier, produce food in a manner that provides the same level of public health protection required under the applicable US food safety regulations (the preventive controls or produce safety regulations, as appropriate). They must perform a hazard analysis for each food, evaluate and approve you as a supplier, conduct verification activities, and keep records that FDA can inspect. They must identify themselves at entry with their name, email address, and DUNS number, and an entry that does not properly identify the FSVP importer can be rejected or delayed.

FSVP applies broadly, but not universally. Certain foods and certain importer or supplier sizes have exemptions or modified requirements. Notably, juice and fish and fishery products subject to FDA's HACCP regulations (21 CFR Parts 120 and 123) are exempt from FSVP — importers instead comply with the importer requirements of those regulations. Other exemptions and modified requirements can apply to very small importers, certain small foreign suppliers, dietary supplements, food for research or evaluation, alcoholic beverages, and food from countries whose food safety systems FDA has officially recognized as comparable or equivalent. Do not assume FSVP applies — or that it doesn't — without checking your specific product. The exemption and modified-requirement analysis is product- and importer-specific — being small does not create a blanket exemption.

Read that again with commercial eyes. Your US buyer is legally required to hold a documented verification file on you. If you cannot supply the evidence that fills that file, they are not being difficult when they push you for paperwork — they physically cannot buy from you and stay compliant. An exporter who responds to FSVP document requests slowly, partially, or defensively is telling their buyer that doing business will create regulatory risk. That is a quiet, permanent disqualification.

What your buyer will need from you

• Evidence of your food safety system. FDA does not generally require a GFSI-benchmarked certificate as a condition of FSVP compliance — but in practice many US buyers use GFSI certification (BRCGS, FSSC 22000, SQF) as supplier evidence inside their own verification programmes. A documented HACCP plan is the minimum most buyers will engage with.
• Audit reports, including the audit summary rather than just the certificate.
• Certificates of Analysis for the relevant hazards — real lab results, not marketing spec sheets.
• Evidence that you control the specific hazards their hazard analysis identified (pathogens, allergens, mycotoxins, heavy metals, pesticide residues, undeclared additives, as applicable to your product).
• Corrective action records where something has previously gone wrong.
• A willingness to support appropriate verification activities, which are risk-based and may include on-site audits, sampling and testing, or review of your food safety records. Where a hazard you control could cause serious adverse health consequences or death (a "SAHCODHA" hazard), an on-site audit before importing the food and at least annually thereafter is the default requirement — unless your buyer documents in writing that other or less frequent verification is adequate.

One structural warning worth knowing: if there is no US owner or consignee at the time of entry — which happens when an exporter ships into a US warehouse before a buyer is found, or sells on delivered terms with no US purchaser yet in place — then the FSVP importer becomes the US agent or representative of the foreign owner, confirmed by a signed statement of consent. In plain terms: someone in the US has to take on the FSVP burden, and if you have structured the deal so that nobody has, that person may end up being your representative. Do not stumble into this arrangement without understanding what you are agreeing to.

FSVP is actively enforced: FDA continues to conduct FSVP inspections and issue warning letters, and non-compliant importers can be placed on Import Alert 99-41, which subjects their shipments to Detention Without Physical Examination. If your buyer lands on that list, your goods stop moving too — regardless of whether you did anything wrong.

Importer of Record is not the same thing as FSVP importer

This distinction catches exporters out constantly, and FDA is explicit about it: the FSVP importer may be — but is not necessarily — the CBP importer of record. The Importer of Record carries the customs responsibility (entry, classification, duties, bond). The FSVP importer carries the FDA food safety verification responsibility. They are often the same company. They do not have to be, and in some supply chains they deliberately are not.

Do not assume the party handling customs is also the party holding your FSVP file. Confirm both roles explicitly, in writing, before you ship. An exporter who discovers at the port that nobody was designated as the FSVP importer has a stranded container and no quick fix.

Labeling — the cheapest way to lose a container

US labeling rules are prescriptive, and non-compliance is a misbranding violation that can get a shipment refused even when the food itself is perfectly safe. Labels are also the one thing you control completely, which makes label failures particularly unforgivable in a buyer's eyes.

The non-negotiables

• Statement of identity — the common or usual name of the food, prominently on the principal display panel.
• Net quantity of contents — in both US customary and metric units.
• Ingredient statement — in descending order of predominance by weight, using common names US consumers would recognise.
• Nutrition Facts panel — in the current mandated format, with added sugars declared.
• Name and place of business of the manufacturer, packer, or distributor.
• Allergen declaration — see below.
• English language. Mandatory labelling information must be presented in English; additional languages may be used provided the labelling remains compliant.

The nine major allergens

US law requires declaration of nine major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Sesame is the newest, added by the FASTER Act and required since January 1, 2023.

Sesame is where exporters still get caught. Many origin markets do not treat it as a major allergen, so it slips through on labels designed for domestic or EU sale. It must be declared — either in the ingredient list under its common name, or in a "Contains" statement. An undeclared allergen is one of the fastest routes to a refusal and a recall.

Bioengineered (BE) food disclosure

Separate from FDA labeling, USDA's National Bioengineered Food Disclosure Standard requires disclosure for foods that meet USDA's definition of a bioengineered food — the test is USDA's own legal definition of a bioengineered food, so the presence of a genetically engineered input does not automatically mean the finished food requires disclosure. Check the definition against your actual product. Disclosure can be made by on-package text, the BE symbol, an electronic/digital link, or a text-message option. This is a distinct requirement from allergen and Nutrition Facts labeling, and it is missed regularly by exporters who assume FDA rules are the whole picture.

Claims are not free

"Healthy," "low sodium," "high in fiber," and similar nutrient content claims are legally defined terms with specific criteria — not marketing language. FDA has issued a final rule updating the definition of "healthy"; manufacturers using that claim have until February 25, 2028 to comply. If you make a defined claim and your product does not meet the criteria, the product is misbranded. If you are exporting a product whose home-market packaging carries claims that were legal there, assume nothing carries over. The claim itself remains voluntary — the rule governs products that choose to use it, not a general labelling deadline.

Certificates and category-specific traps

Phytosanitary certificates (plant products)

Issued by your national plant protection authority, certifying the consignment meets the destination's plant-health requirements. Requirements are destination-specific and product-specific — a certificate that satisfied one market says nothing about the US. Some products additionally require an import permit, treatment, or fumigation with documented evidence. Confirm requirements against APHIS before you commit to a shipment window, not after.

Seafood

Seafood carries its own mandatory HACCP regime (21 CFR Part 123). Both processors and importers have obligations, and importers must have written verification that imported seafood was produced under HACCP conditions. Species authenticity and correct labelling of the market name are enforced, and intentional species substitution can trigger serious misbranding or adulteration consequences, and may be treated as economically motivated adulteration depending on the circumstances.

Low-acid canned foods and acidified foods

If you produce shelf-stable canned, jarred, or pouched foods that are low-acid or acidified — and this catches far more exporters than expected, including some commercially shelf-stable sauces, vegetables in brine and ready meals — you face an additional, separate registration. You must register the establishment (obtaining a Food Canning Establishment number) and file your scheduled processes with FDA before shipping. This is on top of ordinary food facility registration, not instead of it. Discovering this at the port is a very expensive way to learn it.

Juice

Juice products are subject to their own HACCP regulation (21 CFR Part 120), including pathogen-reduction requirements. As with seafood, a general food safety plan is not a substitute for the specific regulatory scheme. If your product could be classified as both a juice and another type of processed food, settle the regulatory classification before assuming the general preventive-controls or FSVP pathway applies.

Organic

To be sold as organic in the US, imported product must comply with the USDA National Organic Program, either through certification to the NOP by an accredited certifier or under a recognised equivalency arrangement. Critically, the certification must cover the actual scope of the transaction — the specific products, operations, handling activities and supply-chain entities covered by the applicable certification or arrangement. Scope mismatches are the most common organic import failure, and organic buyers are specialists who will check. Foreign organic certificates are not automatically accepted on their own — they must be issued under a USDA-recognised arrangement or by a USDA-accredited certifier.

When it goes wrong: holds, refusals, and import alerts

Understanding the enforcement machinery is not pessimism — it is how you price risk and how you reassure a buyer who has been burned before.

Detention and refusal

FDA may detain a shipment that appears to violate the law. You are given an opportunity to respond and, in some cases, to recondition the goods — for example by relabelling — under FDA supervision. If FDA ultimately refuses admission, the goods must be handled in accordance with FDA and CBP instructions — which can include exportation, destruction, or an approved reconditioning or disposition pathway where one is available. Those costs generally fall on the importer, the exporter, or whichever party bears them under the sale and logistics arrangements; FDA and CBP do not reimburse the commercial cost of detention, and demurrage accrues throughout.

Import alerts and Detention Without Physical Examination

This is the outcome to genuinely fear. An import alert allows FDA to detain future shipments without physically examining them — Detention Without Physical Examination, or DWPE. Import alerts can cover specific manufacturers, firms, products, or broad categories and geographic origins. Once you are captured by one, the presumption inverts: shipments are detained without physical examination until the firm provides evidence sufficient for FDA to consider them admissible under the applicable import-alert procedures — typically private laboratory testing at your cost, shipment after shipment.

Getting removed requires submitting evidence that the underlying conditions have been corrected and that future compliance is reasonably assured, following the applicable FDA import-alert guidance. This takes months and costs real money. Meanwhile, the alert is public. Buyers check.

The commercial lesson: an import alert does not just cost you the shipments it detains. It costs you every buyer who searches your name.

Federal entry is not the whole of US market access

This guide covers federal import requirements, because those decide whether your goods arrive. They do not decide everything about whether your product can be sold once it is here.

Individual states can impose additional requirements affecting labelling, packaging, food standards, environmental and recycling claims, dairy, weights and measures, and alcohol distribution. California's Proposition 65 warning requirements are the example most exporters have heard of, but they are not the only one. Ask your buyer which states the product is destined for, and whether anything applies beyond the federal baseline.

Treating FDA clearance as equivalent to US market compliance is a common and costly assumption.

Verify before you ship (the parts that change)

Some US import rules are stable enough to plan around — the ones above. Others change quarterly, or faster. We deliberately do not state current figures for these, because a number printed here would be wrong by the time you read it. Check these against the primary source, dated, before every quote:

• Tariffs and duty rates. The US tariff landscape has been unusually volatile, with multiple authorities in litigation and rates changing on short notice. Never quote a duty-inclusive (DDP) price to a US buyer without a current, dated verification. Primary source: the Harmonized Tariff Schedule at hts.usitc.gov, plus CBP's current guidance.
• FDA fees. Registration itself is free, but other programs carry fees that are revised annually.
• Front-of-package nutrition labeling. FDA has proposed a mandatory "Nutrition Info box" for the front of most packaged foods, but as of this guide's August 2026 review it remains a proposed rule, not a final one. If finalised, compliance is proposed at three years for larger businesses and four for smaller ones. Do not redesign packaging on the basis of a proposed rule — but do not be caught unaware either.
• FSMA 204 (the Food Traceability Rule). This one is genuinely confusing. The rule's original compliance date was January 20, 2026, but FDA proposed a 30-month extension to July 20, 2028, and Congress subsequently directed FDA not to enforce the rule before July 20, 2028. Some FDA pages have continued to display the original date. The requirements themselves — lot-level traceability, Key Data Elements at Critical Tracking Events, records producible to FDA in a sortable electronic format within 24 hours — are not being softened. FSMA 204 is not a universal traceability requirement for every food: it applies to foods on FDA's Food Traceability List and to entities performing covered activities involving those foods. Foreign firms can be caught when they perform those activities. Determine whether your product and your role place you in scope before building a full KDE and CTE system. Treat the extra time as build time, not as a reprieve.
• Country-specific eligibility for meat and poultry (FSIS equivalence lists), which can and does change.

A supplier who says "duty is currently X, verified against the HTS on [date], subject to change" is more credible than one who quotes a confident number that turns out to be stale. Precision about your own uncertainty is a professional signal, not a weakness.

Pre-shipment checklist

1. Confirm your FDA food facility registration is active — and if reading this in 2026, diarise the October 1 – December 31 renewal window now.
2. Confirm your US Agent is current, contactable, and knows they still act for you.
3. Confirm your DUNS number matches the producing facility's physical address.
4. Confirm which agency actually governs your product — and if it is FSIS, confirm country eligibility and establishment approval before anything else.
5. Give your buyer or their broker the exact manufacturer name, address, and registration number for Prior Notice — early, not as the truck approaches.
6. Check your label against the nine allergens, the Nutrition Facts format, English-language requirements, and BE disclosure.
7. Assemble the FSVP pack your buyer will need: GFSI or HACCP evidence, audit summary, lot-specific COA, hazard controls.
8. Confirm any category-specific regime applies or doesn't: seafood HACCP, juice HACCP, LACF/acidified registration, organic scope.
9. Verify duty exposure against a current source, dated — and say so in your quote.
10. State your Incoterm properly, with the named place.
11. Do not quote DDP into the US unless you fully understand what you are taking on. DDP can require you as a foreign seller to take on significant US import responsibilities, and in some structures the foreign seller becomes the importer of record — bringing customs-entry, bond, duty and regulatory obligations that many exporters underestimate. Many exporters quote DDP casually and discover the consequences at the port.
12. Confirm the product's regulatory classification before you quote — food, supplement, beverage, seafood, juice, LACF or acidified, infant formula, alcohol, animal food.
13. Determine whether APHIS, TTB, USDA AMS or state-level requirements apply on top of FDA.
14. If applicable, confirm whether your product appears on FDA's Food Traceability List and whether your role involves covered activities under FSMA 204.
15. Confirm who is the FSVP importer and who is the importer of record — and document that they are distinct roles, even where the same company fills both.

Answer the questions buyers are actually asking

Serious US buyers screen suppliers on exactly the things in this guide — registration status, certifications, allergen handling, documentation readiness — usually inside the first exchange, and often before price is discussed at all. AgrifoodQuote reads an inbound inquiry, flags every certification, document, and specification the buyer asked for, and shows you what is missing before you reply. You set the price and the terms; the tool makes sure nothing the buyer asked for falls through the cracks.