FDA Registration and Prior Notice Regulations for Food Importations

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Newsletters

FDA Registration and Prior Notice
Regulations for Food Importations

The FDA has published two interim final regulations that require (1) registration with FDA of all domestic and foreign food facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States, and (2) advance notice to FDA of any shipment of human or animal food imported or offered for import beginning Dec. 12, 2003.

Newsletter Summaries of the New Rules:

FDA Entries With a Disclaim B will be REJECTED as of April 19, 2020
April 16, 2020
UPDATE CBP COVID-19 Relief Imports Web Portal
April 14, 2020
FDA Provides Updates to the Instructions for Filing PPE During COVID-19
April 7, 2020
Update on CBP Collection of Other Agency Import Data
July 14, 2016
FDA Proposes New Foreign Supplier Verification Program
August 28, 2013
"FDA Invites Comments And Questions Regarding Its New Recordkeeping Requirements"
December 8, 2005
"Revised FDA Guidance on Prior Notice Submissions and Enforcement Policy" (November 15, 2004)
"December Update on the FDA Registration And Prior Notice Regulations" (December 4, 2003)
"FDA's New Registration Requirements For Food Facilities And Prior Notice For Food Imports" (October 27, 2003)
"FDA Issues Interim Final Bioterrorism Regulations" (October 9, 2003)

Bioterrorism Act & Regulations:

Other FDA Materials:

Compliance Policy Guide - Guidance for FDA Staff
(December 2003; Revised November 2004 and August 2006)

Filing Prior Notice Materials

Necessity of the Use of Food Product Categories in Registration of Food Facilities (October 2012)

Questions and Answers Regarding Registration of Food Facilities (Ed.6) (November 2014)

CBP Published Guidance on Interim Procedures (Word document)
FDA's Food Facility Registration Forms
Vulnerability Assessments of FoodSystems (February 2012)
Compliance Policy Guide

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