The Food Safety Modernization Act (FSMA) requires facilities that are required to register under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Sec. 415 of the Federal Food, Drug and Cosmetic Act) to reregister with the U.s> Food and Drug Administration (FDA) on every even-numbered year.  This requirement applies to both U.S. and foreign registered facilities.  U.S. and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. are required to register with FDA.  For questions on this requirement please contact Erik Lieberman at +1.202.830.0300 or

FDA has reminded stakeholders today that it has three guidance documents available to provide assistance to registrants with the registration process, including information on biennial registration renewal. These guidance documents are listed below:

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 to FDA.

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.

These documents supersede previously released versions.

Additional Information