Export Food to USA Requirements

The Five Core Requirements

Before your food product can enter the United States, you must satisfy these five federal requirements:

1. 1

   FDA Food Facility Registration

   Your manufacturing facility must be registered with the FDA under the Bioterrorism Act of 2002. Registration must be renewed every two years (in even-numbered years). Without a valid registration number, U.S. Customs can refuse your shipment.

2. 2

   Prior Notice of Imported Food

   You or your U.S. importer must submit Prior Notice to the FDA before your shipment arrives in the U.S. This is submitted through the FDA's Prior Notice System Interface (PNSI) or through U.S. Customs' Automated Broker Interface. Notice must be submitted no more than 15 days before arrival and no later than 2 hours before arrival by air.

3. 3

   U.S. Agent Appointment

   Foreign food facilities must designate a U.S. Agent — a person or company physically located in the United States — who acts as your point of contact with the FDA. Your U.S. agent receives communications from the FDA on your behalf.

4. 4

   U.S.-Compliant Food Labeling

   Your product label must meet FDA requirements before it reaches U.S. shelves. This includes a Nutrition Facts panel, ingredient list, allergen declarations, net weight, manufacturer address, and more — all formatted to U.S. standards, not your home country's.

5. 5

   Importer of Record

   Every food shipment entering the U.S. must have a designated Importer of Record (IOR) — typically a licensed U.S. customs broker or your U.S. distributor. The IOR is legally responsible for ensuring the shipment complies with FDA and CBP rules.

Labeling Is the Most Common Failure Point

Most shipments that are detained or refused at the border are flagged for labeling violations, not food safety issues. The FDA checks that imported food labels comply with the same requirements as domestically produced food.

Labels must be in English (or bilingual if the primary display is in another language). Your home country's nutrition panel, allergen format, or ingredient order may not meet U.S. standards even if it is compliant in your home market.

• U.S. food label requirements for exporters — full breakdown of what must appear on your label
• FDA allergen labeling requirements — the U.S. recognizes 9 major allergens, more than many countries
• FDA Nutrition Facts label format — U.S. format differs significantly from EU and other international standards

Common Mistakes

• ✕
  Shipping without an active FDA facility registration — this results in automatic detention
• ✕
  Missing or late Prior Notice submission — CBP will hold the shipment at the port
• ✕
  Using European or home-country label formats instead of FDA-compliant ones
• ✕
  No designated U.S. Agent — required for all foreign facilities registered with the FDA
• ✕
  Assuming your product is exempt because it is sold in small quantities — most commercial food exports are subject to full FDA requirements
• ✕
  Not accounting for lead time needed to redesign and reprint labels before launch

Related Guides

• FDA food facility registration requirements
• U.S. agent for FDA food facility
• How to sell food in the U.S. as a foreign company
• FDA label requirements for imported food