CFSAN Constituent Update
August 14, 2012
The U.S. Food and Drug Administration today issued draft guidance on the Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories, as provided by section 102 of the FDA Food Safety Modernization Act (FSMA). FSMA amended section 415 of the Federal Food, Drug and Cosmetic Act, which requires both domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with the FDA. Requiring the submission of food product category information as part of a facility's registration is necessary to allow for a quick, accurate, and focused response to an actual or potential bioterrorist incident or other food-related emergency.
The draft guidance updates the previously issued Guidance for Industry: Necessity of the Use of Food Product Categories in Registration of Food Facilities and proposes additional food categories to be included in the food facility registration form as mandatory fields, including food categories that are currently included on the food facility registration form as optional fields. FDA believes that the additional food categories are appropriate for food facility registration and may include such food categories as mandatory fields in the food facility registration form when FDA finalizes the guidance. FDA intends to issue three other updated food facility registration guidance documents to provide more information regarding FSMA amendments to the food facility registration requirements of section 415 of the Federal Food, Drug, and Cosmetic Act some time later this year.
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