The U.S. Food and Drug Administration (FDA) has issued the “Compliance Policy Guide Sec. 100.250 Food Facility Registration – Human and Animal Food” (the CPG). The CPG provides guidance for FDA staff pertaining to the enforcement of the food facility registration provisions of section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which were amended by the FDA Food Safety Modernization Act (FSMA). Under these provisions, any food facilities which manufacture, process, pack or hold food for human or animal consumption in the United States must be registered with the FDA. Additionally, each registered facility is required to biennially renew their registrations with the FDA. The CPG further describes the FDA’s authority to suspend a food facility’s registration.
In April 2013, the FDA published a draft of the CPG and of the two comments received, no significant changes were recommended to the draft CPG. Therefore, no substantive changes were made from the draft to the final version of the CPG.
Please note that this CPG replaces the previously issued “Compliance Policy Guide Sec. 110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.”
If you wish to obtain additional information on which food facilities must be registered with the FDA, or if you would like assistance in registering your food facility, please feel free to call me at (305) 260-1053, or email me at JDiaz@bplegal.com.