What does a US Importer of Record do for food imports?

A US Importer of Record assumes complete legal and financial responsibility for food shipments entering the United States, including FDA facility registration, FSMA compliance, Prior Notice filing, customs clearance, and payment of all duties and taxes. We ensure your products meet all FDA labelling requirements and coordinate with USDA FSIS for regulated products like meat and poultry.

Do I need FDA registration to import food to the USA?

Yes, FDA facility registration is mandatory under 21 CFR 1.225 for all food facilities, including foreign facilities exporting to the US. Registration must be renewed every two years, and we handle the complete process including initial registration, ongoing compliance, and biennial renewals.

How much does a US Importer of Record cost?

IOR costs vary with shipment value, product complexity and regulatory requirements. Our pricing can include customs bond coverage, FDA compliance management and required documentation. Contact us for a quote based on your food import needs.

What are FDA food labelling requirements for imports?

FDA requires compliance with the Nutrition Labeling and Education Act, including accurate nutritional panels, ingredient declarations in descending order by weight, allergen statements, and proper serving size calculations. We review all labelling for compliance before shipment to prevent costly rejections.

Can a foreign company be a US Importer of Record?

No, the IOR must have a US address, active US phone number, and valid taxpayer identification number. Foreign companies require a US-based IOR partner like Global Import Agent to handle their imports legally and maintain compliance with US regulations.

What happens if food imports don't comply with FDA?

Non-compliant food imports face FDA detention, rejection at the border, or complete destruction at the importer’s expense. Costs can include storage fees, examination charges, and disposal costs. Our proactive compliance approach prevents these expensive outcomes through thorough pre-shipment verification.

Do I need different FDA registrations for food versus medical devices?

Yes, different product categories require specific FDA registrations. Food facilities require FDA food facility registration, medical device companies need establishment registration, and cosmetic facilities have separate registration requirements. We manage all category-specific requirements.

What happens if my shipment is selected for FDA examination?

As your importer of record, we manage all FDA examination processes including providing required documentation, liaising with FDA officials, and coordinating any necessary testing or remediation. We handle all communications and compliance requirements on your behalf.

US Importer of Record for Food Brands: Guide

How Global Import Agent Can Help

International food importers face a complex web of US regulations that can result in costly detention, rejection, or destruction of shipments. As your US Importer of Record, we assume complete legal and financial responsibility for your imports, ensuring compliance with FDA Food Safety Modernization Act (FSMA), facility registration requirements under 21 CFR 1.

225, and proper Prior Notice filing as mandated by 21 CFR 1. 276. Our FDA compliance specialists handle everything from initial facility registration to ongoing nutritional labelling compliance, whilst our customs team manages the required commercial documentation and customs bond arrangements.

We maintain the necessary US address, phone number, and taxpayer identification number required for IOR operations, supporting your market entry.

Complete FDA facility registration and biennial renewals
USDA FSIS coordination for meat, poultry, and egg products
Comprehensive customs bond coverage and entry summary preparation
24/7 monitoring for potential FDA detentions and rapid response protocols

FDA Compliance Management – Complete facility registration, FSMA compliance, Prior Notice filing 2-8 hours before arrival, and ongoing regulatory monitoring
Customs Clearance & Bonding – Minimum £50,000 customs bond coverage, entry summary preparation, duty and tax management, and CBP communication
Documentation & Labelling – FDA nutritional labelling compliance, ingredient declarations, commercial invoice preparation, and bill of lading management

Expert FDA Food Import Compliance Services

Food imports to the United States face some of the world’s strictest regulatory oversight, with the FDA Food Safety Modernization Act (FSMA) requiring comprehensive compliance across manufacturing, labelling, and facility standards. Our team specialises in the intricate requirements of 21 CFR 1.

225 facility registration, ensuring your operations meet FDA Bioterrorism Act registration requirements and maintain current Good Manufacturing Practice (GMP) compliance. Beyond basic registration, we manage the critical Prior Notice requirements mandated by 21 CFR 1. 276, filing notifications 2-8 hours before your shipment’s arrival to prevent costly delays.

For specialised food categories, we coordinate with USDA Food Safety and Inspection Service (FSIS) for meat, poultry, and egg products, securing necessary permits and maintaining ongoing compliance. Our approach includes comprehensive HACCP protocol review and process filing management to ensure your products meet all applicable US food safety standards.

FDA facility registration with biennial renewal management
Complete FSMA compliance including preventive controls verification
Prior Notice filing with automated 2-8 hour advance submission
USDA FSIS coordination for regulated meat and poultry products
Nutritional labelling compliance under FDA Education Act requirements

What We Arrange And Manage End-To-End

1) FDA Facility Registration & Compliance Setup

We establish your FDA facility registration under 21 CFR 1. 225, securing your unique registration number and ensuring compliance with Bioterrorism Act requirements.

Complete facility registration with FDA database
FSMA compliance verification and documentation
Establishment of US agent designation

2) Customs Bond & IOR Documentation

Our team arranges the minimum £50,000 customs bond required for IOR operations and establishes all necessary documentation with US Customs and Border Protection.

Customs bond procurement and ongoing management
US taxpayer identification number setup
Commercial invoice and entry summary preparation

3) Pre-Shipment Compliance Review

Before your goods ship, we conduct comprehensive compliance reviews covering labelling, documentation, and regulatory requirements specific to your food category.

4) Prior Notice Filing & Clearance Management

We file mandatory Prior Notice with FDA 2-8 hours before arrival and manage all clearance procedures, including potential inspections or detentions.

5) Ongoing Compliance & Renewal Management

Our service includes continuous monitoring of regulatory changes, biennial facility registration renewals, and ongoing compliance support for repeat shipments.

Complete US Food Import Support Package

FDA Facility Registration

Complete registration under 21 CFR 1. 225 with biennial renewal management and ongoing compliance monitoring.

Customs Bond Coverage

Minimum £50,000 customs bond with comprehensive coverage for duties, taxes, and potential penalties.

Prior Notice Management

Automated FDA Prior Notice filing 2-8 hours before shipment arrival as required by 21 CFR 1. 276.

USDA FSIS Coordination

Specialist handling of meat, poultry, and egg product imports requiring USDA permits and inspections.

Labelling Compliance Review

FDA nutritional labelling compliance verification and ingredient declaration accuracy under Education Act requirements.

Detention Response Service

24/7 monitoring and rapid response protocols for FDA detentions with expert resolution management.

What Is a US Importer of Record for Food?

A US Importer of Record is the legal entity that assumes complete responsibility for imported goods entering the United States, including compliance with all federal regulations and payment of duties, taxes, and potential penalties.

For food imports, this role is particularly complex due to stringent FDA requirements under the Food Safety Modernization Act (FSMA), facility registration mandates, and specific labelling requirements under the Nutrition Labeling and Education Act.

The IOR must maintain a physical US address, active phone number, and valid taxpayer identification number, whilst ensuring compliance with FDA facility registration (21 CFR 1. 225), Prior Notice requirements (21 CFR 1. 276), and appropriate USDA coordination for regulated products.

Non-compliance can result in FDA detention, shipment rejection, or complete destruction at the importer’s expense, making selection of an experienced food-specialised IOR essential for successful market entry. Before-you-ship checklist:

FDA facility registration completed and current
Nutritional labelling compliance verified for US market
Commercial invoice with accurate product descriptions prepared
USDA permits secured if importing meat, poultry, or eggs
Customs bond coverage confirmed for shipment value

Our process:

Facility registration and compliance verification
Customs bond arrangement and documentation setup
Pre-shipment labelling and regulatory review
Prior Notice filing 2-8 hours before arrival
Customs clearance and ongoing compliance monitoring

Our team includes certified FDA compliance experts with deep knowledge of FSMA requirements, facility registration processes, and food safety regulations. We maintain current certifications and ongoing training to ensure your imports meet the latest regulatory standards.

We assume full legal and financial responsibility as your US Importer of Record, protecting you from costly FDA detentions and penalties. Our proactive approach includes continuous regulatory monitoring and rapid response protocols for any compliance issues.

Beyond IOR services, we provide complete logistics solutions including freight forwarding, warehousing, and customs clearance. Our integrated approach supports coordination between compliance, shipping, and delivery for optimal efficiency.

Our FDA compliance specialists are standing by to discuss your specific import requirements and provide a comprehensive quote for our US Importer of Record services. Contact us today to ensure your food products meet all regulatory standards and reach American consumers safely and legally.

2Before-You-Ship Checklist Before each shipment, we confirm the essentials are in place:

FDA facility registration completed
Product listings and classifications verified
Labelling compliance confirmed
Required certifications obtained
Import documentation prepared

2Initial Compliance Assessment We start with a review of your products and regulatory requirements, identifying the FDA registrations and compliance obligations that apply.

Product classification and regulatory pathway determination
FDA registration requirements analysis
Compliance gap assessment and remediation plan

Our service: US importer of record services · FDA US Agent service

US Importer of Record for Food: FDA Compliance Experts