U.S. Import Compliance Guide

What Is an Importer of Record

The Importer of Record is the U.S. entity legally responsible for ensuring that imported goods comply with all U.S. Customs and Border Protection and Food and Drug Administration regulations. This is the party that files the customs entry, provides the importer number, maintains import documentation, pays duties and taxes, and accepts legal liability for the shipment.

For FDA-regulated products such as food, dietary supplements, cosmetics, medical devices, and drugs, the Importer of Record is one of the most important roles in the entire supply chain. If the shipment has compliance issues, the responsibility falls on the Importer of Record. Without a properly structured Importer of Record, shipments cannot be cleared into the United States.

At FDA Registration Assistance, we help companies around the world establish compliant U.S. import structures so their products move through customs and FDA review without delays.

Why the Importer of Record Is Critical for U.S. Imports

U.S. Customs does not release goods based on the foreign manufacturer or supplier. Every commercial shipment must have a U.S. Importer of Record that is legally responsible for the entry.

If there are labeling errors, missing FDA registrations, incorrect product classifications, or food safety compliance failures, the Importer of Record is the entity that must resolve the issue. This is why choosing the correct IOR structure is one of the most important compliance decisions for foreign exporters, Amazon sellers, and U.S. distributors.

Who Can Act as Importer of Record

The Importer of Record must be a U.S.-based individual or company with a valid U.S. tax identification number. In many cases this is a U.S. distributor, a U.S. subsidiary of a foreign manufacturer, a U.S. brand owner, or the U.S. purchaser of the goods. A foreign company without a U.S. entity cannot serve as the Importer of Record.

Importer of Record for FDA-Regulated Products

When importing FDA-regulated goods, the Importer of Record must ensure that all regulatory requirements are met before the shipment arrives in the United States. This includes confirming that food facilities are registered, Prior Notice is submitted correctly, labeling is compliant, product codes are accurate, and the correct FSVP Importer is declared for food shipments.

If these elements are not aligned, the shipment may be held at the port, detained by the FDA, refused entry, or placed on an Import Alert.

Importer of Record for Amazon FBA Shipments

Amazon never acts as the Importer of Record for your products. The seller or their designated U.S. entity must serve in this role. One of the most common reasons Amazon food and supplement shipments are rejected at the port is an incorrect Importer of Record structure.

Importer of Record vs Consignee vs FSVP Importer vs U.S. Agent

These roles are frequently confused, yet each one serves a completely different legal and regulatory function. The Importer of Record is responsible for the customs entry and the legal importation of the goods into the United States. The consignee is the party that physically receives the shipment after clearance. The FSVP Importer is responsible for food safety verification for imported food. The U.S. Agent represents a foreign facility for official FDA communications.

When these roles are structured correctly before the shipment leaves the country of origin, imports move through the port without unnecessary delays.

Role Comparison

The Importer of Record carries the legal liability for the shipment. The consignee only receives the goods. The FSVP Importer ensures food safety compliance. The U.S. Agent serves as the regulatory communication link with the FDA.

Incorrect role assignment is one of the most common causes of shipment holds, FDA detention, and Amazon delivery rejections.

Can a Customs Broker Be the Importer of Record

A customs broker cannot act as the Importer of Record. The broker files the entry on behalf of the importer but does not assume legal responsibility for the goods.

What Happens If There Is No Valid Importer of Record

If a shipment arrives without a valid Importer of Record, it cannot be cleared into the United States. The goods may remain at the port until storage charges accumulate, be exported back to the country of origin, or be destroyed.

How FDA Registration Assistance Helps

FDA Registration Assistance works with foreign manufacturers, U.S. importers, Amazon sellers, and global distributors to create compliant import structures that align the Importer of Record, FSVP Importer, U.S. Agent, and consignee correctly. This prevents shipment delays and ensures products enter the U.S. market smoothly and legally.

Frequently Asked Questions About the Importer of Record

What does Importer of Record mean

The Importer of Record is the U.S. entity legally responsible for customs clearance, regulatory compliance, and payment of duties for imported goods.

Does the Importer of Record have to be a U.S. company

Yes. The Importer of Record must have a U.S. presence and a valid U.S. tax identification number.

Can a foreign company be the Importer of Record

A foreign company can only act as the Importer of Record if it has an established U.S. entity with a U.S. tax ID.

Is the Importer of Record the same as the consignee

No. The consignee receives the goods, while the Importer of Record is responsible for the legal importation.

Is the Importer of Record responsible for FDA compliance

Yes. The Importer of Record must ensure that all applicable FDA requirements are met before the shipment arrives.

Who pays duties and taxes

The Importer of Record is responsible for paying duties, taxes, and customs fees.

Can Amazon be the Importer of Record

Amazon does not act as the Importer of Record for seller shipments.

What number is used for the Importer of Record

The importer uses their EIN, SSN, or CBP-assigned importer number.

Is a customs bond required

Most commercial imports require a customs bond issued in the name of the Importer of Record.

Can the Importer of Record and FSVP Importer be the same company

Yes. One U.S. entity can hold both roles if it meets the legal requirements for each.

Can the Importer of Record be changed after the shipment ships

Changing the Importer of Record after shipment departure is difficult and often causes major delays.

What happens if the Importer of Record is incorrect

The shipment may be held, rejected, or refused entry into the United States.

Does every shipment need an Importer of Record

Every commercial shipment entering the United States must have a valid Importer of Record.

Is the Importer of Record the owner of the goods

Not always. Ownership is determined by the commercial terms of sale, while the IOR is the legally responsible importer.

How do I set up an Importer of Record for the first time

You must establish a U.S. entity, obtain a tax ID, secure a customs bond, and align your FDA compliance structure before shipping.

Get Help Setting Up Your Importer of Record

FDA Registration Assistance
+1 (928) 275-8333

info@fdaregistrationassistance.com

Serving clients in more than 75 countries with end-to-end FDA and U.S. import compliance solutions.