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U.S. Food Regulatory Authority

The U.S. Food and Drug Administration (FDA) serves as the primary authority overseeing food regulation in the United States. It is tasked with enacting food-related regulations, administering market access procedures, and conducting post-market surveillance. The FDA updates its list of refused import shipments on a monthly basis via its official website.

Official Food Division Website: https://www.fda.gov/food

Applicable Regulatory Legislation

Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)

FDA Food Safety Modernization Act (FSMA)

Title 21 of the Code of Federal Regulations (21 CFR)

Definition and Classification of Food & Facility Registration Rules

Food Facility Registration mandates that all domestic and foreign facilities engaged in manufacturing, processing, packing or holding food intended for human or animal consumption in the United States must complete registration with the FDA.

1.General Foods

Including regular food products, beverages, baked goods, confectioneries and similar items. Compliance requirements consist of facility registration, label review, adherence to FSMA rules, and submission of Prior Notice prior to importation.

2.Special Foods

Low-Acid Canned Foods (LACF), Acidified Foods, infant formula products, certain Dietary Supplements, and specific food/color additives require supplementary product-specific filings in addition to standard formalities.

Food products regulated by the FDA are split into two major categories: human food and animal feed. Acidified Foods and Low-Acid Canned Foods (LACF) carry extra registration obligations.

Prerequisites for Market Access

Complete food facility registration, submit Prior Notice and file required guarantee statements. Additional plant registration and process filings are mandatory for Acidified Foods and Low-Acid Canned Foods (LACF). A valid D-U-N-S Number is required for all facility registrations.

Registration language

English

Mandatory Documentation for Submission

1.Documents for Basic Food Facility Registration

Company D-U-N-S Number, corporate information prepared in English, product specifications and formulations, Letter of Authorization for the U.S. Agent, and electronic signature of the designated responsible party.

2.Documents for Prior Notice Submission

Commercial Invoice, Packing List, Bill of Lading or Air Waybill, product labels (to verify product identity and description), FDA Food Facility Registration Number, product specification sheet and full ingredient list (for FDA Product Code assignment), and relevant certificates if applicable (such as USDA certificates, certificates of origin, Certificates of Analysis).

U.S. Agent System

All overseas manufacturers must appoint a U.S. Agent to serve as the official communication liaison with the FDA. A qualified U.S. Agent is defined as an individual or business entity that resides within the United States or maintains a physical place of business with a tangible presence in U.S. territory.

Filing Procedures, Processing Timelines and Official Fees

1. Registration flow chart

2. Processing Timelines and Fee Information

The FDA does not issue pre-market approvals for food products. Its core responsibilities cover compliance verification of foreign food facilities and processing Prior Notices for customs coordination. The D-U-N-S Number may be supplemented within 60 calendar days after facility registration is finalized, and the official turnaround time for applying for a D-U-N-S Number is approximately 30 days. The FDA imposes no official administrative fees for food facility registration or Prior Notice filings.

Chapter 3 FAQ

Q：What is the scope of FDA's oversight of food facilities?

A：FDA Regulates all foods and food ingredients introduced or offered for sale in interstate commerce, with the exception of meat, poultry, and certain processed egg products regulated by the United States Department of Agriculture (USDA).

The Human Food Program (HFP) works with FDA field offices to ensure that countries' food supplies (with the exception of meat, poultry, and some egg products, which are regulated by the USDA) are safe, hygienic, healthy, and honestly labeled, and that products are safe and properly labeled.

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