Who needs Foreign Food Facility Registration with FDA?

Foreign facilities that manufacture, process, pack, or hold food intended for consumption in the United States are generally required to register with the FDA, depending on the facility role and product type.

Do foreign food facilities need a U.S. Agent?

Yes. Foreign facilities are required to designate a U.S. Agent to serve as the communication point between the facility and FDA. FDA Registration Assistance provides U.S. Agent services for foreign food facilities worldwide.

Is FDA facility registration the same as product approval?

No. FDA Food Facility Registration is a regulatory registration requirement for applicable facilities and is not the same as FDA product approval.

What information is typically needed to register a foreign food facility?

Facilities typically need legal business details, facility address, contact information, emergency contact details, and a designated U.S. Agent. Exact requirements can vary based on facility operations and FDA rules.

Can you help avoid shipment delays at U.S. ports of entry?

Yes. Proper FDA registration and compliance preparation helps reduce the risk of holds, delays, refusals, and enforcement actions at U.S. ports of entry. FDA Registration Assistance supports foreign companies with the required registration steps and related compliance needs.

Do you also support FSVP for U.S. importers buying from foreign suppliers?

Yes. We support U.S. importers with FSVP agent services and documentation to help meet FDA Foreign Supplier Verification Program requirements.

Foreign Food Facility Registration l FDA Experts

Fee: $429 USD / Per Year
(Includes U.S Agent Fee)

FDA Food Import Regulations & Registration Assistance

The United States Food and Drug Administration (FDA) is responsible for ensuring that all food entering the United States—whether produced domestically or imported internationally—is safe for human consumption.

To protect the U.S. food supply, the FDA enforces strict regulatory requirements under federal law. One of the most important laws governing food safety is the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which designates the FDA as the primary food regulatory authority responsible for preventing and responding to potential bioterrorism or intentional contamination of the U.S. food supply.

Under this Act, the FDA has the authority to take all necessary measures to safeguard public health and ensure food safety across the entire supply chain.

FDA Requirements for Importing Food into the United States

To legally manufacture, process, pack, store, or import food into the United States, the FDA requires compliance with two critical regulations:

1. Food Facility Registration (Domestic & Foreign)

All domestic and foreign food facilities that manufacture, process, pack, or hold food for consumption in the United States must be registered with the FDA.

This registration:

Is mandatory
Must be renewed every even-numbered year
Is required before food enters U.S. commerce

2. FDA Prior Notice for Imported Food

The FDA also requires Prior Notice, formally known as Advance Notice of Imported Food Shipments, for every shipment of food entering the United States.

Prior Notice allows the FDA and U.S. Customs and Border Protection (CBP) to:

Review shipment details in advance
Assess potential safety or security risks
Prevent unsafe food from entering the U.S. market

FDA Registration Statistics (as of January 1, 2021)

Foreign Food Facility Registrations: 101,982
Domestic Food Facility Registrations: 80,935

These figures highlight the global scale of FDA oversight and the importance of accurate, compliant registrations.

FDA Registration Assistance – Food Facility & Prior Notice Services

FDA Registration Assistance provides professional regulatory support to both foreign and domestic food facilitiesseeking compliance with FDA requirements.

Our services include:

FDA Food Facility Registration (Domestic & Foreign)
Prior Notice submissions for imported food shipments
Regulatory guidance and ongoing compliance support
Assistance acting as your U.S. Agent when required

We help ensure your registration is completed accurately, efficiently, and in full compliance, reducing the risk of delays, refusals, or FDA enforcement actions.

If you would like more information or need assistance with FDA registration or Prior Notice services, please contact us today.

Frequently Asked Questions (FAQ)

What is FDA Food Facility Registration?

FDA Food Facility Registration is a mandatory requirement for any facility—domestic or foreign—that manufactures, processes, packs, or holds food for consumption in the United States.

Who needs to register with the FDA?

Any food facility involved in producing or handling food destined for the U.S. market must register, including:

Manufacturers
Packers
Warehouses
Distributors
Importers using foreign facilities

Is FDA registration required for foreign facilities?

Yes. Foreign food facilities must be registered and must also appoint a U.S. Agent to communicate with the FDA on their behalf.

What is FDA Prior Notice?

Prior Notice is an advance electronic notification submitted to the FDA before food shipments arrive in the United States. It is required for every imported food shipment, regardless of size or value.