How to Export to the United States.
A step-by-step guide for foreign manufacturers looking to enter the US market with FDA-regulated products.
Your Roadmap to US Market Entry
Follow these seven steps to ensure your products can legally enter the United States.
Determine Your FDA Category
Identify whether your product falls under food, drugs, medical devices, or cosmetics. Each category has different FDA registration requirements, labeling standards, and compliance obligations. Getting this right from the start prevents costly delays later.
Register Your Facility with FDA
Use the FDA FURLS (Food Facility Registration) or DRLS (Drug Registration and Listing System) online portals to register your manufacturing facility. Food facilities must renew registration biennially during the October-December renewal window.
Designate a U.S. Agent
All foreign facilities registered with the FDA are required to designate a U.S. Agent. This must be a person or business located in the United States that is available to FDA during normal business hours to serve as a communication liaison.
Obtain Required Numbers
Depending on your product type, you may need an FEI (FDA Establishment Identifier), DUNS number, NDC (National Drug Code) for pharmaceuticals, or other identifiers. These numbers are essential for FDA tracking and import entry.
Comply with Labeling Requirements
All products entering the US market must have English-language labels meeting FDA specifications. This includes nutrition facts (for food), drug facts (for OTC drugs), ingredient lists, allergen declarations, and proper net quantity statements.
File Prior Notice (Food)
For food shipments, Prior Notice must be filed with FDA no more than 15 days in advance and no less than 8 hours (vessel), 4 hours (air), or 2 hours (truck/rail) before the product arrives at the US port of entry. This is submitted through the Prior Notice System Interface (PNSI) or through the Automated Commercial Environment (ACE).
Work with a Customs Broker
A licensed customs broker can help you navigate CBP (Customs and Border Protection) clearance, prepare import documentation, and ensure all duties and tariffs are properly handled. This is strongly recommended for first-time exporters.
Common Mistakes to Avoid
These are the most frequent issues we see with first-time exporters.
Not Registering Before Shipping
Your facility must be registered with FDA before products arrive at a US port. Shipments from unregistered facilities will be refused entry.
Expired Registration
Food facility registrations must be renewed biennially. An expired registration means your products cannot legally enter the US.
Missing U.S. Agent
FDA requires an active U.S. Agent at all times. If your agent resigns or becomes unavailable, you must designate a replacement immediately to maintain compliance.
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