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How to enter the US market from Italy: first steps for an SME

First steps for an Italian SME selling in the US: market size, what the FDA does and doesn't ask for food and cosmetics, how to look up your tariff code, entity options, channels and support.

How to enter the US market from Italy: first steps for an SME

The US Census Bureau counts $74.4 billion of goods imported from Italy in 2025. Your own share of that pile may be tiny, or zero, and it hardly matters. The first shipment brings the same questions for everybody. What rules does the product have to meet? What duty does it pay? Who imports it, who handles the tax, and who can help you?

This guide covers how to enter the US market in the order an Italian SME meets those questions. In about ten minutes you’ll know how big the market is, what the FDA does and doesn’t ask of food and cosmetics, how to look up your tariff yourself, when a US company makes sense and what support exists. New to all this? Start from the beginner’s map from zero to a first round.

In short

  • The US Census Bureau counts $74.4 billion of goods imported from Italy in 2025, against $76.0 billion in 2024 and $72.8 billion in 2023. ISTAT reports that Italian exports to non-EU countries grew 2.3% in 2025, and that sales to the US dipped 0.4% in December 2025.
  • Food first. The FDA says plainly that it can’t approve, certify or license importers, products, labels or shipments. What it asks is different. Food facilities register. Prior Notice has to be given. Importers follow the Foreign Supplier Verification Program (FSVP).
  • Cosmetics sit under MoCRA. If you make or process them, you register the facility and renew every two years. A responsible person lists each product and keeps the safety records, and serious adverse events get reported within 15 business days.
  • Look up your tariff yourself at hts.usitc.gov. The schedule changes often: revision 20 of the 2026 edition came out on 28 September 2026. We don’t quote duty rates here, because they can change between writing and reading.
  • You can sell in the US without a US company, through an importer. An LLC or a C-corporation, often in Delaware, comes later: when you hold stock, hire staff or raise US money.

Why enter the US market? What the numbers say

Two sets of official numbers, from two countries, in two currencies. Start with Italy’s. ISTAT said on 29 January 2026 that exports to non-EU countries grew 2.3% over 2025 as a whole, while sales to the US dipped 0.4% in December 2025. For the size of the market in dollars, the clearest official source we found is on the American side.

The US Census Bureau’s Trade in Goods with Italy page puts US imports from Italy at $74.4 billion in 2025, $76.0 billion in 2024 and $72.8 billion in 2023. Against 2024 that’s a fall of about 2%. Against 2023 it’s a rise of about 2%. Expect ISTAT’s euro figures to differ from these dollar figures. Each side counts in its own currency and in its own way, so pick one source for your plan and stay with it.

What does that mean for you? A market this deep is also a market where every Italian competitor in your category may already be present. Size says the pool is big. It doesn’t say your product, at your price, wins a place in it. That comes from the scorecard in our market entry strategy guide and from the work below.

What rules does your product have to meet?

A product that’s legal in Italy isn’t automatically legal on an American shelf. Start with who regulates your category. The table covers the two we checked at the source.

ProductWhat the US agency saysWhat it means for you
FoodFDA: it isn’t authorized to approve, certify, license or sanction individual food importers, products, labels or shipments. Facilities must register and Prior Notice must be given. Importers follow the Foreign Supplier Verification Program (FSVP).No FDA approval to wait for, but registration and Prior Notice are required. Agree with your importer who does what on the FSVP before the first order.
CosmeticsFDA, under MoCRA: manufacturers and processors register facilities and renew every two years. A responsible person lists each marketed product with its ingredients, updates the listing annually and keeps safety substantiation records. Serious adverse events are reported within 15 business days.If your company’s name is on the label, you’re the responsible person. Have the safety file and the listing ready before the first shipment.
Everything elseEach category has its own agency and its own rules: electronics, toys, machinery, textiles, wine and spirits.Ask your importer or a US customs broker for the list before you quote. Don’t assume.
Sources: FDA, Importing Food Products into the United States (content current as of December 2024); FDA, MoCRA (updated 10 August 2026). Consulted 5 October 2026.

One thing worth knowing about food. The agency says in so many words that it doesn’t approve or certify importers, products, labels or shipments. Which is why a pitch for an FDA-approved food product should make you suspicious. Ask the seller to say, in writing, what exactly is being offered.

Other products bring other names. The FCC covers devices that use radio signals, Wi-Fi and Bluetooth among them. Many American buyers also ask electrical products for a test-lab mark such as UL. Whether any of this applies to you depends on the product and on the buyer. Ask your importer before you quote.

How do you find the tariff for your product?

The first number to push up your shelf price is duty. The US tariff goes by the name Harmonized Tariff Schedule, or HTS, and the US International Trade Commission keeps it online at hts.usitc.gov. Reading it for your own product takes five steps.

  1. Say your product is a pasta shape or a ceramic tile: your customs paperwork already shows a code for it. Begin there. Its first digits come from the Harmonized System, a coding scheme for products that many countries share.
  2. Now go to hts.usitc.gov and look the code up, or search by words. Several lines may look right. Careful: the US adds digits of its own to the international code, so match the full description, not just the first digits.
  3. Read the notes and the rate columns that apply to you. Then ask whether extra duties are stacked on the base rate for your product or for the country it comes from.
  4. Put today’s date beside the rate you copy. The USITC put out revision 20 of the 2026 schedule on 28 September 2026, which is why a number noted in spring can be stale by now.
  5. Show the code to your importer or customs broker and let them confirm it before any price goes out. A wrong code means a wrong duty.

We don’t quote rates in this guide. A figure lifted from a blog post shouldn’t end up in a quote to a customer. To see how duty stacks up with freight and margins, look at the price walk in the same market entry guide, which uses invented numbers.

Do you need a US company? LLC or C-corporation

Not to start. An importer or distributor buys from you in Italy, and the US side becomes its job. The day you park stock in the US, hire someone there, sell straight to consumers or take money from US investors, a company over there starts to make sense.

The two forms you’ll hear about are the LLC and the C-corporation. The LLC is the lighter one to run. The C-corporation is the form US venture capital investors generally expect, which is why founders who plan to raise pick a Delaware C-corp. State fees are small: Delaware’s minimum franchise tax for a corporation is $175 under the authorized shares method, or $400 under the assumed par value method, plus a $50 annual report fee, due on 1 March (Delaware Division of Corporations, checked 5 October 2026).

The real cost is the work around the company: US tax filings, a US bank account, and an accountant who understands both countries. An Italian company that owns a US subsidiary has duties at home too, so talk to a commercialista before you incorporate.

If investors are in the picture, the structure has its own logic. Our guide to the Delaware flip explains why US investors sometimes ask Italian startups to move the parent company to the US, and investor tax breaks in Italy and the US shows what differs on each side.

Importer, distributor, marketplace or your own shop?

Channels are a menu, and our market entry guide compares them in a table. One question is specific to the US: who is the importer of record? That’s the party legally responsible for the customs entry, and for the duty when the goods arrive. Settle it in writing with every channel. With a distributor it’s usually the distributor. Ship straight to consumers, and it can land on you.

Starting small? A marketplace or your own online shop lets you test demand with a few orders, mostly from consumers (B2C). Importers and distributors work with businesses instead (B2B), and what they offer is a place on the shelf and local logistics. In exchange they take a margin, so compare that margin with the volume they can really deliver.

What changes with payments and tax?

Three things surprise Italian sellers. First, the US has no single national VAT: sales tax is a matter for the individual states, and in some places for cities too. Second, a state can ask a seller to collect its sales tax even without an office there, once the seller has enough of a presence in it, and sales into the state can count. That’s called nexus. Third, currency. Quote in dollars and the exchange rate becomes your risk. Quote in euros and it becomes your buyer’s, who may then ask for a lower price.

Thresholds and rules differ from state to state, so we don’t list them. If you sell to consumers rather than through an importer, get advice from a US-qualified tax professional before the first sale, not after the first letter from a state.

Who can help? ICE, SIMEST and the New York offices

ICE, the Italian Trade Agency, has offices in 70 countries, New York among them. Its guide to exporting and investing in the USA presents itself as a first orientation (“informazioni di primo orientamento”) on rules and procedures for doing business there. Start with it if you want an Italian public body’s view of the US.

On money, SIMEST’s market-entry loan has specific terms for US projects: 8 years including 2 of pre-amortisation, and a 10% grant share, on a page updated on 23 September 2026. SIMEST also announced a New York office in September 2026. The details are in our guide to SIMEST financing. Looking at the southern half of the continent instead? Read how to expand to Latin America.

Your checklist before the first shipment

  • Your importer or distributor agreed in writing, including who is the importer of record.
  • Your product category’s rules checked at the agency, not on a blog.
  • Food: facility registered, Prior Notice planned, FSVP agreed with the importer.
  • Cosmetics: facility registered, products listed, safety file ready, label naming the responsible person.
  • HTS code looked up, with the date you checked written beside it.
  • Price walk built with the duty you found and set against a US shelf price.
  • Price currency chosen, and who carries the exchange risk.
  • A US-qualified tax adviser asked about sales tax, before you sell to consumers.
  • The ICE and SIMEST pages read for US-specific support.
Do I need FDA approval to export food to the US?

No. The agency says it has no power to approve, certify or license an individual food importer, product, label or shipment. What it asks of you is simpler: register the facility, and file Prior Notice for imported food.

How do I find the US tariff for my product?

Open hts.usitc.gov, type in a description of the product or its code, and read the line that matches. Your importer or customs broker should confirm you picked the right one. And write the date down, because the schedule gets revised all the time.

Do I need a US company to sell in the US?

Not to start. You can sell to a US importer or distributor from Italy. Once you keep stock there, hire staff, sell straight to consumers or take money from US investors, a US company begins to make sense.

How much did Italy export to the US in 2025?

About $74.4 billion in 2025, a little under the $76.0 billion of 2024, according to the US Census Bureau. Italy’s own side of the story comes from ISTAT, in euros and counted differently, so don’t blend the two in one calculation.

Can SIMEST help with a US project?

Yes. SIMEST’s market-entry loan has specific terms for US projects: 8 years including 2 of pre-amortisation and a 10% grant share, per its page updated on 23 September 2026. Check the current page before you plan around it.

This article is general information, not legal or tax advice. Rules and tariffs change: check the official agency pages and ask a US-qualified professional before you ship, incorporate or collect sales tax.

Adaxit

Planning your first US shipment or entity? We help you map the market, channel and budget before you spend.

Sources

  1. US Census Bureau, Trade in Goods with Italy, consulted 5 October 2026
  2. ISTAT, Commercio estero extra Ue, dicembre 2025, 29 January 2026
  3. FDA, Importing Food Products into the United States, content current as of December 2024, consulted 5 October 2026
  4. FDA, Modernization of Cosmetics Regulation Act of 2022 (MoCRA), updated 10 August 2026
  5. USITC, Harmonized Tariff Schedule information, consulted 5 October 2026
  6. ICE, Guida: Esportare e Investire negli USA, consulted 5 October 2026
  7. SIMEST, Inserimento sui mercati esteri, updated 23 September 2026, consulted 5 October 2026
  8. Delaware Division of Corporations, Franchise tax, consulted 5 October 2026
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For information only: this is not investment advice or a public offer.

About the author

Cassio Thiengo

Prepares startups and SMEs to raise capital and open new markets across Europe, the US and Latin America, and works with investors from Europe, the Gulf and Asia. Based in Milan.

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