In November 2016, the U.S. Food and Drug Administration (FDA) published draft guidance for industry on Questions and Answers Regarding Food Facility Registration (Seventh Edition).
Pursuant to section 415 of the Food, Drug and Cosmetic Act (FDCA), all U.S. and foreign facilities that process, pack and hold food for consumption in the U.S. must registered with FDA. Foreign facilities must appoint an agent in the U.S. to serve as a point of contact for FDA among other things. The Food Safety Modernization Act (FSMA) added a new requirement for food facilities to renew their registration on every even-numbered year between October 1 and December 31.
The draft guidance may be found here. The draft guidance adds new questions and answers, the key ones of which are summarized in this U.S. Food Imports regulatory alert.