How International Food Businesses
Enter the US Market

Overview

Entering the US food market as a foreign business is a multi-step process involving FDA regulations, US Customs and Border Protection (CBP), business formation, and commercial partnerships. This guide maps the complete pathway.

Step 1 — Determine Your Regulatory Pathway

Not all food products follow the same US regulatory pathway. Your first step is identifying which agency regulates your product:

• FDA — governs most food products including packaged food, fresh produce, seafood, dietary supplements, beverages, and animal food
• USDA FSIS — governs meat, poultry, and certain egg products
• USDA AMS — governs organic certification and certain agricultural commodities
• TTB — governs alcohol beverages

Seafood is regulated by FDA under 21 CFR Part 123 (Seafood HACCP) — a separate pathway from the standard FSVP framework that applies to other food categories.

Step 2 — Form a US Business Entity

While not always legally required, forming a US LLC or corporation is strongly recommended for any foreign food business entering the US market. A US entity allows you to act as the FDA-registered importer, open US bank accounts, sign contracts with US distributors, and build US credit history.

New Mexico and Wyoming are the two most cost-effective states for foreign-owned LLCs. New Mexico has no annual report requirement, making it the lowest ongoing cost option. Wyoming offers stronger privacy protections. Both states allow non-US residents to form and own LLCs remotely without ever visiting the United States.

Step 3 — FDA Food Facility Registration

Foreign food facilities that export to the US must register with FDA. Registration requires designating a US Agent — a US-based person available to receive FDA communications. ClearPath handles FDA registration and US Agent services.

Step 4 — FSVP Compliance

As the US importer, you are required under FSMA to maintain a Foreign Supplier Verification Program for each foreign supplier. Your FSVP plan documents your hazard analysis and supplier verification activities, and must be available to FDA within 24 hours of request.

Step 5 — US Customs Clearance

All commercial food imports must be cleared through US Customs and Border Protection (CBP). This requires a licensed customs broker, FDA Prior Notice filed before the shipment arrives, and in some cases an ISF (Importer Security Filing) submitted 24 hours before vessel loading. A continuous customs bond is required for frequent importers.

Step 6 — US Banking and Payment Infrastructure

Once your LLC is formed and your EIN obtained, you can open a US business bank account. Mercury and Relay are recommended for non-US resident founders — both are online-first banks with strong API integrations and no monthly fees. Wise Business is suitable for international transfers but has limited domestic US banking functionality.