5 Facts to Help with your FDA Facility Registration Renewal

By Hilary Thesmar, PhD, RD, CFS, Chief Food and Product Safety Officer and Senior Vice President, Food Safety Programs, and Stephanie Harris, Chief Regulatory Officer and Legal Counsel, Food Marketing Institute

It’s that time again. It’s Q4 of 2018 which means that food facilities must renew their registration with the FDA. Renewal of facility registration occurs during Q4—October 1 through December 31—of even numbered years. If you haven’t done so already, the current registration renewal for 2018 will be available through December 31, 2018. Under the Food Safety Modernization Act (FSMA), the FDA requires biennial registration of all domestic and foreign food facilities engaged in manufacturing, processing, packing, or holding food for human or animal consumption in the United States.

Here are 5 facts to help you with your FDA Food Facility Registration Renewal:

1. Facility registration began in 2002 under the Bioterrorism Act

FDA Facility Registration was originally established under the Bioterrorism Act of 2002. However, FSMA amended the Food Drug & Cosmetic Act to require that domestic and foreign facilities provide additional new information to FDA as well as renew their facility registrations every other year.

2. Updating your registration is different than renewing your registration

If your food facility registration is not renewed by 11:59 PM on December 31st, the registration will expire and be removed. The FDA has the authority to suspend the registration of a food facility. The FSMA statute and regulations also state that the failure to register a food facility is a prohibited act.

3. Retail stores do not need to register stores

Farms and retail operations, such as grocery stores, do not have to register, while retailer-owned distribution centers must register as “holding” facilities, and retailer-owned commissaries and central kitchens that are not part of a retail location must also register. See FDA’s Retail Food Establishment Exemption Flowchart to determine if you qualify for the exemption.

4. Registration is simple

Before December 31, go to the FDA registration site and renew your registration electronically. Although registration renewals can be submitted by paper; 2018 is the last renewal that FDA will accept paper submissions.

5. FDA has a number of resources to help companies with the registration process, including information on biennial registration renew.

• Food Facility Biennial Registration Fact Sheet
• Food Facility Registration User Guide: Biennial Registration Renewal
• Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)
• The Guidance for Industry: What You Need to Know About the Registration of Food Facilities – Small Entity Compliance Guide
• Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration

Do you have questions? Feel free to contact FMI Food Safety at foodsafetyteam@fmi.org.