How to Sell Food in the U.S. as a Foreign Company

Step-by-Step: Entering the U.S. Food Market

1. 1

   Register Your Facility with the FDA

   Before you can ship food to the U.S., your manufacturing facility must be registered with the FDA. Registration is done online through the FDA's Unified Registration and Listing System (FURLS). You will receive a registration number that must be renewed every two years. See FDA food facility registration requirements.

2. 2

   Appoint a U.S. Agent

   All foreign food facilities registered with the FDA must designate a U.S. Agent — a person or company physically located in the United States. Your U.S. agent is your official point of contact with the FDA. This is separate from your importer or distributor. See U.S. agent for FDA food facility.

3. 3

   Redesign Your Label for the U.S. Market

   Your current label almost certainly does not meet FDA requirements. You will need an FDA-compliant Nutrition Facts panel, ingredient list in English in descending weight order, allergen declarations (including sesame), net weight in dual units, and a U.S. address. See U.S. food label requirements for exporters.

4. 4

   Find a U.S. Importer or Distributor

   You will need a U.S. Importer of Record (IOR) to legally bring your product through U.S. Customs. This can be a licensed customs broker, a U.S. distributor who buys from you directly, or a specialty food importer. Your U.S. distributor will also be responsible for the Foreign Supplier Verification Program (FSVP) requirements under FSMA.

5. 5

   Submit Prior Notice for Each Shipment

   Before every shipment enters the U.S., your importer must submit Prior Notice to the FDA through the FDA's PNSI system or via U.S. Customs. Notice must be submitted before arrival — at least 2 hours before arrival by air or truck, 4 hours by sea. See FDA compliance for imported food products.

6. 6

   Choose Your Distribution Channel

   Once your product clears customs, you have several options: sell through a U.S. specialty food distributor (like KeHE or UNFI), direct to retail accounts, through Amazon.com, or via an e-commerce storefront shipping from U.S. inventory. Each channel has different requirements for labeling, certifications, and minimum order quantities.

Labeling: The Most Common Barrier

Of all the steps above, label compliance is where most foreign brands get delayed or blocked. The U.S. label format is significantly different from EU, Canadian, Australian, and most international standards. Key differences include:

• The FDA Nutrition Facts panel layout is specific — serving sizes must use RACC values, not your own
• The U.S. has 9 major allergens including sesame (added in 2023) — more than most other countries require
• Net weight must be declared in both ounces/pounds and grams/kilograms
• All mandatory information must be in English with minimum font sizes

Common Mistakes Foreign Companies Make

• ✕
  Shipping without FDA facility registration — shipments are automatically held at the border
• ✕
  Using the home-country label — even a CE-compliant EU label is not FDA-compliant
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  Printing labels before verifying FDA compliance — reprints are expensive and cause launch delays
• ✕
  No U.S. Agent designated — required for all FDA-registered foreign facilities
• ✕
  Choosing a distributor before the label is compliant — distributors often require FDA-ready labels before agreeing to carry a product
• ✕
  Underestimating lead time — FDA registration, label redesign, and finding an importer can take 3–6 months combined

Related Guides

• Export food to USA requirements — complete overview
• FDA food facility registration requirements
• U.S. agent for FDA food facility
• U.S. food label requirements for exporters