On On April 4, 2013, the U.S. Food and Drug Administration (FDA) published its Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration—Human and Animal Food. This compliance policy guide, when finalized, will provide a resource to FDA staff on the requirements of food facility registration under Section 415 of the Federal Food, Drug, and Cosmetic Act (FDCA) and aid the Agency in determining whether parties subject to food facility registration are compliant with all applicable laws and regulations. The draft is available here.
Section 415 was added as an amendment to the FDCA by Section 305 of the Public Health, Security, and Bioterrorism Preparedness and Response Act of 2002. It primarily establishes the requirement that the owner, operator, or agent of a domestic or foreign food facility, as defined by 21 CFR 1.227, where food is manufactured, packed, or held for human or animal consumption, complete food facility registration with the FDA. Failure to maintain such food facility registration, regardless of whether the food actually enters interstate commerce, is prohibited under Section 301(dd) of the FDCA. Applicable exceptions to this requirement are listed in 21 CFR 1.226.
The Food Safety and Modernization Act (FSMA), enacted on January 4, 2011, added additional requirements to Section 415 and the requirements pertaining to food facility registration. Registration applications, for example, must include the email address of the contact person for a domestic facility, the email address of a US agent for a foreign facility, and a guarantee that the FDA will be permitted to inspect the facility as authorized by the FDCA.
Additionally, Section 415 (a)(3), as amended by the FSMA, requires that a food facility registration be renewed by the FDA biennially. More specifically, any food facility that previously registered with the FDA must submit a renewal from October 1 to December 31 of each even numbered year. An abbreviated process is available when no changes have been made to the previously submitted application. The FDA will consider the facility to have failed to comply with the mandatory food facility registration if its registration is not renewed.
Finally, Section 415(b) authorizes the FDA to suspend a facility’s food facility registration under certain circumstances. Particularly, if the FDA finds that food manufactured, processed, packed, received, or held at a registered facility has a reasonable probability of causing serious adverse health consequences to humans or animals, the FDA will suspend the registration of the facility. If a facility with a suspended registration, moreover, introduces food from the facility into interstate or intrastate commerce in the United States, it will be subject to an appropriate enforcement action by the FDA.
In sum, the comment period for the draft ends on May 6, 2013. You can read more detailed information about food facility registration here. If you have any questions about compliance with the food facility registration requirements or how a FDA regulatory attorney may help you, please contact us at: [email protected]. 