Under the Food Safety Modernization Act (FMSA), all domestic and foreign facilities that manufacture, pack or store food, food ingredients, pet foods or dietary supplements are required to renew their registration with the U.S. Food and Drug Administration (FDA) before the end of 2014 and to re-register every two years thereafter.
Food importers must provide the Food Facility Registration Number of any foreign manufacturer, processor, packer or holder of imported foods or beverages to the FDA and U.S. Customs and Border Protection (CBP) prior to the arrival of the imported food or beverage to the United States, through the FDA Prior Notice filing. Any imported foods or imported beverages not in compliance with FDA’s food facility registration requirements may be refused by FDA or CBP.
Foreign food facilities must also designate a U.S. Agent when registering their food facility with the FDA. The U.S. Agent is a person or entity located within, or that maintains an office, in the United States. The U.S. Agent plays the role of the domestic representative for the foreign facility through which all communication with the FDA takes place.
The FDA provides the following guidance documents to assist companies with the registration process, including information on biennial registration renewal:
- The Guidance for Industry: What You Need to Know About the Registration of Food Facilities – Small Entity Compliance Guide was updated in 2012 to reflect FSMA amendments to the FD&C Act, and contains information regarding: who is required to register and who may be exempt; how often facilities must register and renew registrations; when FDA may suspend a registration; and how facilities may submit their registrations and registration renewals.
- The Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition) was updated in 2012 and contains helpful questions and answers regarding food facility registration. Updates to questions in this edition are based on FSMA amendments.
- The Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registration contains information regarding food-product categories included in the food facility registration form.
Additional information on the Registration of Food Facilities can be found here.