AN IMPORTANT MESSAGE FROM THE U.S. FOOD AND DRUG ADMINISTRATION

November 7, 2014

Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities that are required to register with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. To date, FDA has not received your facility’s renewal for period 2014.

• If you registered your food facility before October 1, 2014, you must return to the FDA Industry Systems site at http://www.access.fda.gov/ before December 31, 2014 to renew your registration and to provide us with any updated information, if applicable.
• If you updated your food facility registration before October 1, 2014, you must return to the FDA Industry Systems site at http://www.access.fda.gov/ before December 31, 2014 to renew your registration and to provide us with any updated information, if applicable.
• As a reminder, if you are the new owner of a registered food facility, the previous owner is required to cancel the food facility’s registration within 60 calendar days of the change of ownership and you must re-register the facility reflecting the new ownership (see 21 CFR 1.234 and 1.235).

FDA 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.

For more information, please visit: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm

Please remember that this renewal process repeats every two years on even-numbered years from October 1 through December 31. You may wish to set a reminder.

Please contact the FDA Industry Systems Help Desk at furls@fda.gov, toll-free in the USA 1-800-216-7331, or 301-575-0156 if you require additional assistance.