• FDA Updates Guidance Related to Food Facility Registration
  • December 6, 2016 | Authors: Colleen M. Heisey; Laura E. Koman; Francoise S. Labrousse; Katherine M. Llewellyn; Cristiana Spontoni
  • Law Firms: Jones Day - Washington Office ; Jones Day - Paris Office ; Jones Day - Brussels Office
  • This month, in the middle of the renewal period for registration of food facilities, FDA has published the seventh edition of its draft guidance "Questions and Answers Regarding Food Facility Registration," which clarifies the Amendments to the Registration of Food Facilities final rule of July 14, 2016 (in effect since September 12, 2016). Details about the final rule can be found in a previous issue of Jones Day's Food, Dietary Supplement & Cosmetics Regulatory Update.

    The draft guidance contains 15 sections with approximately 60 answers to questions, including what information must be submitted to register, update, cancel, or renew registration of a facility, and what the consequences of failing to do so are. Some of the topics that have been clarified by FDA are the meanings for each of the activity types under which a facility can be registered, and the fact that if a facility's initial registration is submitted prior to October 1 of a biennial renewal year (food facility registration is required every other even-numbered year), a renewal must still be submitted for the facility during the period beginning on October 1 and ending on December 31.

    In addition, FDA stated that a company's DUNS number is FDA's preferred unique facility identifier ("UFI"), and the Agency will publish any additional UFIs it might recognize as acceptable before the requirement takes effect on October 1, 2020. FDA will consider comments for finalizing the guidance if submitted by February 6, 2017.