Expanding Into the United States Without Establishing a U.S. Office

The United States is one of the world's most attractive markets for foreign manufacturers, exporters, and international e-commerce businesses. Companies located in Europe, Asia, Africa, Latin America, the Middle East, and other regions increasingly use Amazon Fulfillment by Amazon (FBA), independent distributors, and third-party logistics providers to reach American customers.

However, importing commercial merchandise into the United States involves more than arranging international transportation. Businesses must determine who will legally act as the Importer of Record, how the merchandise will be declared to U.S. Customs and Border Protection (CBP), and whether additional federal agencies regulate the goods.

A common misconception is that a foreign company must establish a U.S. corporation, rent an American office, or employ personnel in the United States before it can import products under its own business name.

In many circumstances, that is not necessary. U.S. customs regulations permit qualifying nonresident importers to make customs entry through appropriate arrangements. A foreign company may obtain an importer identification number using CBP Form 5106 and work with a licensed customs broker, resident agent, and surety to meet applicable requirements.

This opportunity is particularly important for international Amazon sellers who own inventory overseas and intend to ship products directly to American fulfillment centers while retaining ownership of their merchandise.

This guide explains how these separate requirements work together and how experienced regulatory consultants can coordinate documentation, customs arrangements, FDA compliance, and shipment preparation.

What Is a U.S. Importer of Record?

The Importer of Record, commonly abbreviated as IOR, is the party responsible for making customs entry and meeting the legal requirements associated with the importation of merchandise into the United States.

Under 19 U.S.C. 1484, entry generally may be made by the owner or purchaser of merchandise or a properly designated licensed customs broker acting on behalf of the appropriate party.

The Importer of Record is responsible for exercising reasonable care in declaring imported goods accurately. Hiring a customs broker does not automatically transfer the importer's underlying legal responsibilities to that broker.

The customs importer must also understand that different agencies may use different definitions of importer. A company recognized by CBP as Importer of Record is not necessarily the importer recognized by FDA for food safety, medical devices, or other regulated product categories.

Can a Foreign Company Become an IOR Without a Physical U.S. Presence?

Yes. A qualifying foreign company may act as a nonresident Importer of Record without establishing a physical U.S. office or incorporating a domestic subsidiary solely for customs purposes.

This arrangement is commonly referred to as nonresident importing. It allows foreign businesses to retain commercial control over imported inventory while using professional U.S. customs representatives to perform entry procedures.

Under 19 CFR 141.18, additional requirements apply to nonresident individuals, partnerships, and corporations. These may include a resident agent authorized to accept service of process and appropriate customs bond arrangements.

For a nonresident corporation, the resident agent requirement generally concerns the state where the port of entry is located. The customs broker and legal adviser should confirm the appropriate arrangement for the company's intended ports and entry structure.

A foreign company may also need to evaluate U.S. sales tax, income tax, inventory ownership, product liability, and marketplace obligations. These matters are separate from CBP importer registration and should be reviewed with qualified tax and legal advisers.

Understanding CBP Form 5106: Create or Update Importer Identity

CBP Form 5106 is officially titled "Create/Update Importer Identity Form." It is used to establish or update identification information for importers and certain other parties involved in customs transactions.

Importer identification records help CBP administer customs entries, bonds, release of merchandise, duty collection, refunds, and related compliance activities.

U.S. businesses frequently use an Employer Identification Number (EIN) as their customs importer identification number. Foreign companies that do not possess an appropriate IRS identification number may request a CBP-assigned importer number.

Form 5106 includes provisions for requesting a CBP-assigned number, including circumstances where the applicant is not a U.S. resident or lacks an IRS number.

The applicant should use the currently accepted form and submission instructions, as document revisions and electronic procedures may change.

Official information is available from U.S. Customs and Border Protection .

Step-by-Step Process for a Foreign Company to Become an Importer of Record

The order of individual tasks may vary. For example, customs brokers and sureties may request additional documentation before accepting a foreign importer. Certain FDA registrations or authorizations must be completed before the merchandise is shipped or offered for import.

Importer registration should therefore be viewed as one component of a coordinated import-readiness program rather than a standalone authorization.

Customs Bonds, Power of Attorney, and Resident Agent Requirements

A customs bond provides financial security for obligations owed to CBP. Depending on the transaction, these obligations may include customs duties, taxes, fees, and other amounts covered by the bond.

Foreign companies planning repeated commercial imports often consider continuous bonds. Businesses importing only occasionally may evaluate single-transaction bonds.

Bond availability, required amounts, collateral, premiums, and underwriting conditions depend on the importer, merchandise, shipment values, applicable duties, and surety requirements.

A licensed customs broker generally requires a valid power of attorney authorizing the broker to conduct customs business on the importer's behalf. A broker power of attorney should not be confused with the resident-agent arrangements required under the applicable nonresident-entry rules.

Shipping Products Directly to U.S. Amazon FBA Warehouses

Amazon FBA enables international sellers to store merchandise in Amazon-operated fulfillment centers. Amazon then performs eligible storage, order fulfillment, and customer delivery functions.

However, Amazon does not act as the Importer of Record for FBA inventory shipments. The seller must arrange a suitable importer and customs clearance process.

This distinction is especially important when the foreign seller retains ownership of its products during international transportation and U.S. customs entry.

A foreign seller should not identify Amazon or an Amazon fulfillment center as the Importer of Record without an appropriate legal basis. Amazon's published policy states that its fulfillment centers will not serve as IOR for FBA inventory.

Importer, consignee, delivery destination, and ship-to-party information must be distinguished carefully. The address of an Amazon warehouse is a logistics destination, not automatically the legal identity of the customs importer.

Sellers should also review Amazon's current category restrictions, product documentation requirements, labeling rules, and applicable marketplace policies.

Importing FDA-Regulated Products: Different Products, Different Rules

FDA regulates a broad range of products entering the United States. The applicable requirements depend on product identity, ingredients, intended use, claims, manufacturing activities, and statutory classification.

Obtaining a CBP importer number does not constitute FDA approval, product clearance, establishment registration, or permission to market a regulated product.

Businesses should complete product-specific regulatory assessments before making commercial shipping commitments.

FDA Food Facility Registration: Who Must Register?

Under section 415 of the Federal Food, Drug, and Cosmetic Act, domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the United States generally must register with FDA unless an exemption applies.

The requirement can apply to facilities handling food for humans and animals, including dietary supplements, pet foods, animal feeds, and qualifying medical foods.

A foreign food facility required to register must designate a U.S. Agent for FDA communications. The U.S. Agent serves as a contact point between FDA and the foreign facility.

Registration also requires accurate facility information and an acceptable Unique Facility Identifier (UFI). FDA currently recognizes the D-U-N-S number as an acceptable UFI.

Facility registration is generally associated with the actual regulated facility. A trading company's mailing address or virtual office cannot simply substitute for the physical location of a manufacturing facility.

Food Facility Registration Exemptions

Not every company involved in food commerce must obtain its own food facility registration. The legal requirement depends on the activities conducted at each facility.

Certain farms, qualifying retail food establishments, restaurants, and other operations may qualify for statutory or regulatory exemptions.

A company performing only administrative, brokerage, or sales activities may not operate a facility requiring registration. Nevertheless, its suppliers, manufacturers, packers, or storage facilities may have separate obligations.

Facilities handling food that remains subject to the exclusive jurisdiction of USDA under applicable laws may also be treated differently for FDA food facility registration purposes.

Exemptions must be assessed based on the actual operation, ownership, activities, products, and relevant regulations. A small business is not automatically exempt merely because it has limited sales or few employees.

An exemption from food facility registration also does not necessarily eliminate prior notice, FSVP, labeling, or other applicable import obligations.

FDA Food Facility Registration Renewal: 2026 Deadlines

FDA requires covered food facilities to renew their registration every two years during the period beginning October 1 and ending December 31 of each even-numbered year.

The 2026 renewal period ends at 11:59 p.m. on December 31, 2026, according to FDA's published renewal guidance.

A facility that registered earlier in 2026, before the renewal period, must still renew during the applicable 2026 cycle. Updating a registration is not necessarily the same as completing biennial renewal.

Facilities should verify their legal names, physical addresses, UFI information, business activities, product categories, emergency contacts, and U.S. Agent details.

Required registration information changes generally must be updated within 60 calendar days, subject to applicable rules. Changes in ownership may require cancellation and new registration rather than a routine update.

A registration not properly renewed may expire, disrupting the facility's ability to support lawful food imports.

Government Fees, Service Fees, and Import Compliance Costs

Foreign businesses should distinguish official government charges from professional service fees. Different agencies and regulatory programs use different fee structures.

Additional government user fees may apply to medical devices, drugs, certain pharmaceutical facilities, and other regulated activities. Such fees are not interchangeable with the FDA food facility registration fee.

Customs duties, merchandise processing fees, applicable harbor maintenance fees, tariffs, examination charges, storage, transportation, and other logistics costs must be budgeted separately.

Companies should request an itemized quotation identifying the government charges, professional fees, annual services, and any additional third-party expenses.

Foreign Supplier Verification Program: Why FSVP Is Critical for Foreign Sellers

The Foreign Supplier Verification Program (FSVP) is a major requirement under the FDA Food Safety Modernization Act (FSMA).

FSVP generally requires covered importers to verify that foreign suppliers produce food in accordance with applicable U.S. food safety standards.

Under 21 CFR 1.500, the FSVP importer generally is the U.S. owner or consignee of the food at the time of entry.

If no U.S. owner or consignee exists, the FSVP importer is the U.S. agent or representative of the foreign owner or consignee, as confirmed in a signed statement of consent.

Typical FSVP Activities

A qualified individual must perform applicable FSVP activities. Some foods and importers are exempt or subject to modified requirements.

A foreign seller should not assume that a freight forwarder, customs broker, Amazon, or the food facility's U.S. Agent has automatically agreed to serve as its FSVP importer.

The FSVP importer arrangement must be valid, documented, and supported by the actual compliance activities required for the relevant food.

CBP Importer, FSVP Importer, FDA U.S. Agent, and Initial Importer

International businesses frequently encounter several regulatory terms that sound similar but carry different legal meanings.

A single organization may sometimes perform more than one role, but each role must be independently assessed and appropriately documented.

For example, a U.S. regulatory consultant may serve as the foreign food facility's U.S. Agent while a different organization acts as the FSVP importer and the foreign company remains the CBP IOR.

Medical device Initial Importer requirements are separate from customs importer identification. Designating a foreign company as CBP IOR does not automatically resolve those FDA device obligations.

FDA Prior Notice, Customs Entry, and Import Documentation

Most food imported or offered for import into the United States requires FDA prior notice, unless a specific exemption applies.

Prior notice provides FDA with information about the food, its origin, manufacturer, shipper, and anticipated arrival.

Filing deadlines depend on the transportation mode and applicable regulatory rules. Businesses should coordinate submissions with the customs broker or another authorized filer.

Typical commercial import documentation includes the commercial invoice, packing list, transportation documents, customs entry data, and applicable agency information.

Additional documentation may include product specifications, certificates of analysis, ingredient declarations, manufacturing records, labels, permits, and regulatory authorization records.

Ocean cargo may also require Importer Security Filing (ISF), subject to the applicable shipment and transportation requirements.

Accurate product descriptions and harmonized tariff classifications are essential. Inaccurate customs declarations may cause shipment delays, additional assessments, penalties, or enforcement action.

FDA Labeling and Product Compliance Before Shipping

Foreign manufacturers should review U.S. labeling requirements before printing commercial packaging or shipping inventory to Amazon warehouses.

A product legally marketed in Europe, Asia, or another jurisdiction is not automatically compliant with U.S. requirements.

Disease-treatment claims, unapproved drug ingredients, unsupported health claims, incorrect allergens, and missing required labeling information can create serious compliance concerns.

Amazon may also request documents beyond those required for customs clearance. Sellers should maintain organized regulatory records that can support both FDA inquiries and marketplace reviews.

Consequences of Failing to Meet Customs and FDA Requirements

Incomplete importer registration, inaccurate customs entry information, expired facility registration, or failure to meet applicable FDA requirements may create significant commercial disruption.

Other possible consequences include product relabeling, destruction, exportation, corrective action, increased inspection scrutiny, and financial losses.

Some violations may also lead to civil or criminal enforcement, depending on the facts and applicable law.

Preventive compliance planning is generally more efficient than attempting to resolve a regulatory problem after merchandise reaches a U.S. port of entry.

Why Foreign Companies Benefit From Professional Regulatory Consultants

Running an international business can be stressful. Manufacturers and exporters must manage production schedules, suppliers, quality control, transportation, advertising, sales, customer service, and financial planning.

U.S. customs and FDA compliance introduce another layer of complexity. Requirements may differ by product, business activity, agency, and import transaction.

Experienced regulatory consultants help foreign businesses identify applicable obligations, organize documentation, communicate with service providers, and prepare for regulatory inquiries.

Bilingual consultants can also reduce communication difficulties between foreign manufacturers and U.S. customs brokers, regulatory agencies, logistics providers, and commercial partners.

ITB HOLDINGS LLC offers regulatory consulting and compliance support for foreign companies seeking access to the American market. Services can be coordinated with licensed customs brokers and other qualified professionals where their involvement is required.

Regulatory Services Available Through ITB HOLDINGS LLC

Service scope depends on the product, the company's regulatory responsibilities, the selected engagement, and applicable professional authorizations. Customs brokerage, legal representation, and tax advice should be provided by appropriately qualified professionals.

Supporting Manufacturers, Exporters, and Distributors Worldwide

International companies frequently face similar challenges when entering the U.S. market, regardless of their country of origin.

These challenges include understanding unfamiliar regulatory terminology, identifying the correct importer, meeting documentation requirements, preparing compliant labels, and coordinating with American logistics providers.

Multilingual regulatory assistance can be especially valuable for companies in Europe, Asia, Africa, Latin America, and the Middle East.

A coordinated regulatory approach helps international businesses maintain consistent documentation across manufacturers, freight forwarders, customs brokers, FSVP importers, and marketplace service providers.

Practical Example: A Foreign Food Manufacturer Selling Through Amazon FBA

Consider a foreign manufacturer that produces packaged specialty food products and intends to sell them through Amazon.com.

The company has no employees, office, or subsidiary in the United States. It intends to retain ownership of the inventory while the goods are imported and delivered to Amazon.

The company first confirms that it is eligible to act as a nonresident customs importer. It appoints an appropriate customs broker, addresses the resident-agent requirements, and obtains suitable bond coverage.

With assistance from the broker, the manufacturer submits the required importer identity information through CBP Form 5106 procedures and obtains the appropriate importer identification number.

Separately, the company verifies that its food manufacturing facility has valid FDA registration and an appropriate U.S. Agent.

Since no U.S. owner or consignee exists at the time of entry, the company arranges a qualifying U.S. FSVP importer with documented consent and the necessary compliance program.

Before shipping, the company reviews U.S. food labels, product ingredients, supplier records, prior notice requirements, tariff classification, and Amazon FBA instructions.

The customs broker then coordinates entry of the merchandise. Once customs and applicable FDA release requirements are satisfied, the logistics provider arranges delivery to the designated Amazon fulfillment center.

Pre-Shipment Compliance Checklist for Foreign Companies

Companies should retain copies of relevant registration confirmations, contracts, customs records, supplier documents, labels, shipping records, and compliance assessments.

Documentation should be maintained according to the retention periods applicable to each regulatory program rather than assuming one universal retention period applies to all records.

A U.S. Physical Office Is Not Always Necessary to Import Into the United States

Foreign companies seeking to expand into the American market have several possible import structures. For qualifying businesses, nonresident Importer of Record arrangements provide a practical way to import merchandise without establishing a physical office in the United States.

CBP Form 5106 is an important component of this process because it enables creation or updating of the importer's identity record. Foreign companies lacking an appropriate IRS number may be able to obtain a CBP-assigned importer number.

Nevertheless, successful importing requires more than obtaining an identification number. Businesses must arrange customs entry, suitable bond coverage, appropriate representation, accurate declarations, and compliance with applicable federal regulations.

For FDA-regulated products, additional requirements may include facility registration, biennial renewal, U.S. Agent designation, FSVP compliance, prior notice, product listing, labeling review, or other product-specific authorizations.

Amazon FBA creates valuable distribution opportunities, but it does not eliminate customs or FDA responsibilities. International sellers must establish a compliant importer structure before shipping inventory to fulfillment centers.

By working with experienced regulatory consultants, licensed customs brokers, and other qualified service providers, foreign manufacturers and exporters can better organize their compliance responsibilities, reduce avoidable shipment disruptions, and focus on developing their U.S. commercial activities.