July 25, 2014

FDA Extends Food Facility Registration Renewal Deadline and Issues Guidance Documents

The FDA recently announced that it will defer enforcement of the deadline for the biennial food facility registration renewal from Dec. 31, 2012 until Jan. 31, 2013. The action results from the FDA’s delay in opening the registration renewal process from Oct. 1 until Oct. 22, 2013. The FDA is encouraging companies to complete the process early.

The announcement also noted that the registration form requires three new items of information: (1) an e-mail address for the contact person for the facility or, in the case of a foreign facility, the e-mail address of a U.S. agent for the facility; (2) an assurance that the FDA will be permitted to inspect the facility at all reasonable times and in a reasonable manner; and, (3) if deemed necessary by the FDA, information on additional food categories manufactured, processed, packed or held at the facility. For more information on the additional categories, please see our Alert dated Aug. 24, 2012, which can be found here.

At the same time, the FDA issued two Guidance documents on the food facility registration process. These Guidance documents answer many basic questions about the food facility registration process. The first Guidance document, “Guidance for Industry: What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide,” can be found here, and the second, “Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition),” can be found here.


About the Author

Barnes & Thornburg's Food, Drug & Device Law practice group helps pharmaceutical, biotechnology, medical device, diagnostic, food, dietary supplement and cosmetic companies, as well as other healthcare entities, throughout the product lifecycle, from concept, development and approval to manufacturing, marketing, ongoing compliance, investigation, enforcement actions and litigation. We advise clients on the ever-evolving laws and FDA regulations that govern their products and components. Moreover, we have the government experience and industry knowledge necessary to...


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