FDA Details Requirements for Small Entity Facility Registration

FDA has issued a Small Entity Compliance Guide (SECG) to help food facilities meet their registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FD&C Act requires that food facilities engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the U.S. register with the FDA. The Food Safety Modernization Act (FSMA) added new registration provisions to the FD&C Act.

In 2016, FDA issued a final rule to reflect these changes, which include the following:

• Facilities are required to provide FDA with assurance that they will be permitted to inspect their facility (in accordance with the FD&C Act).
• Facilities are required to renew their registration every other year.
• FDA now has the authority to suspend a facility’s registration.

Under the 2016 final rule, additional information is also required that supports FDA’s ability to respond quickly to food-related emergencies and that will also help the agency more efficiently use the resources it has for inspections.

The SECG explains which types of facilities are required to register, and when and how to do so. The guide also explains the consequences for facilities that fail to register or to renew their registration as required, when FDA can suspend a facility’s registration, and the effect of a suspension order. To further assist small facilities, the SECG includes an “At-a-Glance” that summarizes all of the key information in the document.  

In addition to the SECG, FDA also updated its Registration of Food Facilities webpage to include a flowchart meant to help facilities determine if they are considered a retail food establishment, which would mean that they are exempt from food facility registration requirements and not required to register.