Chapter 1 Registration Background

1.Eaa and Introduction

FDA（U.S. FOOD & DRUG Administration) The Food and Drug Administration of the United States of America is responsible for food regulation, market access and post-market supervision. The FDA's website updates the list of rejected imports every month.

2. Supervision and regulation

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

FDA Food Safety Modernization Act (FSMA)

Title 21, Code of Federal Regulations (21 CFR)

3. Food classification

Food products regulated by the FDA, which are classified as human food and animal food, have additional registration requirements for acidified/low-acid canning foods (LACF).

4. Entry requirement

Food plant registration and pre-declaration and completion of warranty statement, additional plant registration and process filing for acidified/low acid canning food (LACF);

A Dun & Bradstreet code is required for factory registration.

5. Registration language

   English

6. U.S.Agent American agent

Manufacturers are required to appoint a U.S. agent to communicate with the FDA.

A U.S. agent is a person, including an individual or business entity, who resides in the United States or has a place of business in the United States and is physically present in the United States.

Chapter 2 Registration process, cycle & Government fee

1. Registration flow chart

2. Registration period and official fees

The FDA is not responsible for food approval, but is responsible for compliance reviews of imported food plants, and submits pre-declarations for customs follow-up. Among them, Dun & Bradstreet code can be supplemented within 60 natural days after the completion of registration, and Dun & Bradstreet code application official provision time is 30 days.

The FDA does not charge an official fee.

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.