FDA Issues Guidance Documents Regarding Food Facility Registration and Biennial Registration Renewal
CFSAN Constituent Update
December 12, 2012
The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d]. The registration requirements in section 415 of the FD&C Act apply to domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. Section 102 of FSMA amended section 415 of the FD&C Act in relevant part to provide that food facilities required to register with FDA must renew their registrations with FDA every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year.
FDA issued a guidance document stating that because there was a delay in FDA’s implementation of biennial registration renewal for the 2012 cycle, and registration renewal did not become available until October 22, 2012, FDA intends to exercise enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013. See Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition). Facilities are encouraged to renew their registrations early.
FSMA also amended section 415 of the FD&C Act to provide FDA with the authority to suspend a food facility’s registration in certain circumstances involving food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals. The guidance documents being issued today are:
Guidance for Industry: What You Need to Know About the Registration of Food Facilities – Small Entity Compliance Guide was updated to reflect the FSMA amendments to the FD&C Act, and contains information regarding: who is required to register and who may be exempt; how often facilities must register and renew registrations; when FDA may suspend a registration, and how facilities may submit their registrations and registration renewals to FDA. Some additional registration information that must be provided in a facility’s registration, as provided by FSMA, include: the email address of the U.S. agent for the foreign facility, and an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.
Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition) contains helpful questions and answers regarding food facility registration. Updates to questions in this edition are based on the FSMA amendments.
These documents supersede previously released versions.