FDA Releases Compliance Policy Guide on Food Facility Registration
By Heidi Parsons
The U.S. Food and Drug Administration (FDA) on June 2 published the final version of “Compliance Policy Guide Sec. 100.250 Food Facility Registration – Human and Animal Food” (the CPG), which provides guidance for FDA staff on enforcing the food facility registration provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Food Safety Modernization Act. Those provisions include:
- the requirement that certain food facilities register with FDA,
- the requirement that registered facilities biennially renew their registrations with FDA, and
- FDA’s authority to suspend a food facility’s registration.
These registration requirements apply to food facilities that manufacture, process, pack, or hold food for human and animal consumption in the United States. 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.”
In its announcement of the document's availability, FDA noted that in April 2013, FDA published a draft of the CPG and received two comments, both of which did not recommend significant changes to the draft CPG. No substantive changes were made from the draft to final version of the guide.
For more information, see:
FDA's guidance for industry, "What You Need to Know About Registration of Food Facilities" provides information on how to submit registration for a food facility through FDA’s electronic portal at www.access.fda.gov. It also provides information on how to submit paper registration. A 107kb PDF may be downloaded via this link.