On August 15, 2012 the Food and Drug Administration (FDA or the Agency) announced in the Federal Register the availability of draft guidance for industry entitled “Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories” (“Draft Guidance”). The Draft Guidance identifies additional food categories to be included in food facility registrations as determined appropriate by FDA. FDA has stated that “this guidance, if finalized. . .will have binding effect.” The Food Marketing Institute (FMI) comments on the binding effect of the Draft Guidance. FMI appreciates the opportunity to comment on this important matter.

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