The U.S. Food and Drug Administration (FDA) announced on June 2, the availability of "Compliance Policy Guide Sec. 100.250 Food Facility Registration – Human and Animal Food" (CPG). The CPG provides guidance for FDA staff on 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 Food Safety Modernization Act (FSMA) to require more information.
By way of background, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) amended the FD&C Act by adding section 415, which requires domestic and foreign facilities that manufacture, process, pack or hold food for consumption in the U.S. to register with FDA. Notably, the implementing rules excluded food contact substances (including packaging materials) and pesticides from the definition of "food," thereby exempting facilities that produce only food contact substances from the rule. Facilities that produce food contact substances that may also be used as direct food ingredients (e.g., pulp that is used in supplements as a source of fiber) are subject to the provisions of section 415 of the FD&C Act and therefore must be registered.
The CPG replaces "Compliance Policy Guide Sec. 110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002," and includes sections on food facility registration requirements, the requirement for biennial registration renewal, and FDA's authority to suspend a food facility's registration.