FSMA revised draft released

Going into the Christmas holidays the Food and Drug Administration released a revised draft guidance for industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.”

The late December announcement from the FDA said the revised draft “contains 17 sections of a multi-section guidance intended to provide updated information and answer frequently asked questions regarding FDA registration requirements.”

The 2016 Food Facility Registration biennial renewal period began on Oct. 1 and ended Dec. 31, 2016. Food facilities that manufacture/process, pack or hold food for consumption in the United States are required to register with the FDA.

According to the statement from the FDA, the revised draft guidance “supersedes the version of the food facility registration draft guidance that we announced on Nov. The revised draft guidance now includes ‘Who is Exempt from Registration?’ and ‘Definitions,’ from the draft guidance. Also, this revised draft guidance includes an additional question and answer related to mobile facilities in the Section titled ‘What Information is Required in the Registration?’ When finalized, this guidance is intended to provide updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act).”

Although comments can be made on any guidance at any time, the FDA said “to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 27, 2017.”

For more information on the newest draft, visit
Federal Register Notice
Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry

And for more information on FDA’s Food Safety Modernization Act, visit http://www.fda.gov/fsma.