U.S. market entry for international brands fails far more often on paperwork and pricing than on product. We regularly meet Australian, British and Israeli founders with a brand that is genuinely winning at home, a retailer in the United States who is interested, and no viable way to actually ship, clear customs, invoice or price the product without destroying the margin. The United States is not one more export market. It is a different regulatory regime, a different margin structure and a different retail calendar, and the sequence you do things in determines whether the launch is profitable.
Brand Refinery is a CPG consulting firm that helps international consumer brands enter the U.S. market, covering entity and compliance setup, importing, pricing and retail partnerships with Walmart, Target, Kroger, Whole Foods, Costco, Ulta and Sephora. This guide is the sequence we run with founders, in the order it has to happen.
Start With the Question Nobody Asks First
Before entity structures and customs bonds, answer this: at what U.S. retail price does your product still make money, and is that price competitive on a U.S. shelf?
Work it backwards. Take a realistic U.S. shelf price for your category. Remove the retailer's margin. Remove the distributor's margin if you are going through one. Remove trade spend, which for a first year in U.S. retail commonly runs 15 to 25 percent of gross sales. Remove freight, duty and any applicable tariffs, U.S. warehousing, and the cost of the compliance work below. What is left is your contribution per unit.
Many international brands discover at this point that a product with healthy margin at home is break-even or negative in the United States, because the U.S. margin stack has more layers and more promotional expectation than most home markets. That is a strategy finding, not a reason to stop, but it has to be found in a spreadsheet rather than after the first purchase order. Our breakdown of what it actually costs to launch a consumer brand in the U.S. sets out the full cost stack.
If the arithmetic does not work, your options are a different pack size or format for the U.S., a different channel, U.S.-based manufacturing, or a different price positioning. All four are decisions to make before you build the infrastructure.
Step 1: Decide Whether You Need a U.S. Entity
You do not strictly need a U.S. entity to sell into the United States. You do need one for most things you will actually want to do.
A U.S. entity, typically an LLC or C-corporation, gives you a U.S. Employer Identification Number, the ability to open U.S. business banking, a clean way to contract with distributors and retailers, and a domestic party that can serve as importer of record. Most large U.S. retailers strongly prefer, and some effectively require, contracting with a U.S. entity with U.S. banking for payment.
The alternative is selling to a U.S. importer or distributor who buys from you at your port and takes on everything downstream. That is simpler and cheaper to start, and it costs you control and margin. It is a reasonable first step for a brand testing the market and a poor permanent structure for a brand that intends to build one.
Entity structure has tax consequences that vary by your home country's treaty position with the United States. Take advice from a cross-border accountant before you form; this is one of the few decisions that is genuinely expensive to reverse.
Step 2: Sort the Importer of Record and Customs Bond
Every shipment entering the United States needs an importer of record: the party legally responsible for the entry being accurate, and for paying duties, taxes and fees.
- A U.S. entity with an EIN can be importer of record.
- A foreign company can also act as importer of record without a U.S. entity, using a CBP-assigned importer number obtained through CBP Form 5106.
- Or your U.S. distributor can be importer of record, which shifts the liability and the paperwork to them.
You also need a customs bond. A continuous bond covers a year of shipments and must be at least 10 percent of the prior year's duties, taxes and fees, with a $50,000 minimum. Annual premiums for a standard $50,000 continuous bond commonly run in the range of $400 to $700. Single-entry bonds exist for one-off shipments and stop making sense quickly once you ship regularly.
One 2026 note that catches importers out: tariff changes over the past two years have raised duties materially in several categories, and because bond amounts are calculated from prior-year duties, brands whose duty bill has grown may find their existing bond is now insufficient. Review the bond amount with your customs broker rather than assuming last year's figure still applies. Duty and tariff rates are specific to your product's classification and country of origin; get a binding ruling or a broker's written classification rather than relying on a general figure.
Engage a licensed customs broker early. They file the entry, and a good one will catch a classification or valuation problem before it becomes a penalty.
Step 3: FDA Registration and the U.S. Agent
This is where international brands most often lose time.
Food and beverage
Foreign facilities that manufacture, process, pack or hold food for consumption in the United States must register with the FDA. There are limited exemptions, including farms, restaurants and retail food establishments.
Every foreign facility must also designate a U.S. agent for FDA communications. The agent must be located in the United States, available during U.S. business hours, and is the party FDA contacts about inspections and import alerts. This is a named, real responsibility, not a mailing address.
Registrations must be renewed biennially, and the 2026 renewal window runs from October 1 to December 31, 2026. Missing it can result in cancellation of the registration, which stops your shipments at the border until it is restored. If you registered in a previous cycle, put the renewal in the calendar now.
Separately, Prior Notice must be submitted to FDA before every food shipment arrives at a U.S. port of entry, under 21 CFR Part 1 Subpart I. It is filed through FDA's Prior Notice System Interface or through CBP's ACE portal, usually by your broker.
The Foreign Supplier Verification Program
If you are importing food, the U.S. importer carries an FSVP obligation: a written Foreign Supplier Verification Program for each food and each foreign supplier, developed and implemented by a qualified individual. It requires hazard analysis, supplier verification activities, and confirmation that the food is not adulterated and is correctly labeled with respect to allergens. Records are kept for at least two years, and FDA operates an importer portal for electronic records submission.
The practical point for an international brand: if you are the importer of record, FSVP is your obligation, not your co-packer's. If your U.S. distributor is the importer, it is theirs, and they will ask you for the documentation. Either way, someone has to build it, and FSVP inspections are a routine part of FDA's import work.
Beauty and personal care
Cosmetics are governed by the Modernization of Cosmetics Regulation Act. Facility registration identifies where products are made; product listing identifies what is sold. Both are submitted through FDA's Cosmetics Direct portal, and foreign facilities must designate a U.S. agent for registration purposes. Facility registrations renew every two years, but the renewal date is driven by your own initial registration date rather than a single industry-wide deadline, so confirm your specific date rather than assuming a common one. Enforcement and inspection activity has been increasing through 2026.
Our FDA labeling compliance guide covers the labeling rules that apply on top of registration, and our Sephora guide covers the prestige beauty route specifically.
Step 4: Relabel for the United States
Your home-market label will almost certainly not comply. Expect to redesign for:
- U.S. Nutrition Facts or Supplement Facts formatting, which differs from the panels used in the UK, EU, Australia and Israel.
- U.S. units and serving size conventions.
- U.S. allergen declaration requirements.
- Claim rules that differ from home-market rules. Claims that are routine in Australia or the EU can be non-compliant or misleading in the United States.
- Country of origin marking.
Budget for a compliance review by a U.S. regulatory specialist before the print run, not after. Relabeling a container that has already arrived is expensive, and an import alert is worse.
Step 5: Choose the Channel, Then the Retailer
International founders often arrive with one U.S. retailer in mind because a buyer expressed interest at a trade show. Interest is not a plan.
The realistic sequence for most imported brands is:
- A beachhead region, not the whole country. The United States is a continent. A brand that is strong in the Northeast is a real brand; a brand thinly distributed nationally is invisible everywhere.
- A channel that matches your positioning. Natural and specialty retail generally rewards imported provenance and premium pricing. Conventional grocery and mass reward scale and price, which is where imported cost structures struggle most.
- A distributor relationship appropriate to the channel. Our UNFI and KeHE onboarding guide covers the natural channel route and the margin stack it carries.
- Velocity data before expansion. U.S. buyers expand on units per store per week, not on how well the brand performs at home. Home-market success is context; it is not evidence a U.S. buyer will act on.
A Realistic Timeline
For a brand starting from nothing in the United States, plan roughly:
- Months 1 to 2: margin model, channel decision, entity and tax advice.
- Months 2 to 4: entity formation, EIN, banking, customs broker and bond, FDA registration and U.S. agent, FSVP or MoCRA work started.
- Months 3 to 6: U.S. label redesign and compliance review, U.S. pack and pricing architecture, 3PL selection.
- Months 5 to 9: distributor conversations and first buyer meetings.
- Months 9 to 15: first purchase orders, EDI and vendor setup, launch.
Brands that compress this usually do so by selling to a U.S. importer who handles everything, accepting lower margin in exchange for speed. That is a legitimate choice. What does not work is skipping the compliance steps and hoping the shipment clears.
How Brand Refinery Helps
We run this sequence with international founders end to end: the margin model that decides whether to proceed, the entity and compliance setup, the importing infrastructure, the U.S. pack and label architecture, and the distributor and buyer introductions that follow. Our U.S. market entry services are built for exactly this, and we work from offices in Atlanta and Dallas.
If you are an international brand planning a U.S. launch, book a call and we will start with the numbers.
Frequently Asked Questions
Do international brands need a U.S. entity to sell in U.S. retail?
Not strictly, but in practice most do. A U.S. entity provides an EIN, U.S. business banking, a clean contracting party for distributors and retailers, and a domestic importer of record. Many large U.S. retailers strongly prefer or effectively require contracting and paying a U.S. entity. The alternative is selling to a U.S. importer or distributor who buys at your port and handles everything downstream, which is simpler to start but costs margin and control.
What is an importer of record and who should it be?
The importer of record is the party legally responsible for the accuracy of a U.S. customs entry and for paying duties, taxes and fees. It can be a U.S. entity with an EIN, a foreign company using a CBP-assigned importer number obtained through CBP Form 5106, or a U.S. distributor who takes on the role. Whoever is importer of record also carries the Foreign Supplier Verification Program obligation for imported food, so the choice determines where compliance responsibility sits.
When does FDA food facility registration need to be renewed in 2026?
FDA food facility registrations are renewed biennially, and the 2026 renewal window runs from October 1 to December 31, 2026. Failing to renew can result in cancellation of the registration, which prevents shipments from entering the United States until the registration is restored. Foreign facilities must also keep their designated U.S. agent information current, because that agent is the party FDA contacts regarding inspections and import alerts.
What is FSVP and does it apply to my brand?
The Foreign Supplier Verification Program requires the U.S. importer of a food product to maintain a written verification program for each food and each foreign supplier, developed by a qualified individual. It covers hazard analysis, supplier verification activities and confirmation that the food is not adulterated and is correctly labeled for allergens, with records kept at least two years. It applies to the importer of record, so if your brand imports its own product into the United States, the obligation is yours rather than your manufacturer's.
How long does U.S. market entry take for an international CPG brand?
For a brand building its own U.S. infrastructure, a realistic timeline is nine to fifteen months from first planning to first retail purchase order: one to two months for the margin model and channel decision, two to four months for entity, banking, customs and FDA registration, three to six months for label compliance and packaging redesign, and several months for distributor and buyer conversations. Selling through an established U.S. importer is faster but delivers lower margin and less control.
This article is general information for brand operators and is not legal, tax, regulatory or financial advice. Customs classifications, duty and tariff rates, and FDA requirements vary by product and change over time; confirm your specific obligations with a licensed customs broker, a cross-border accountant and a U.S. regulatory specialist before acting.