FDA has issued a revised guidance that explains the necessity of having food product categories in food facility registrations submitted to FDA under section 415 of the FD&C Act (21 U.S.C. 350d), and that updates the food product categories to be used in food facility registrations. See generally Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition): Guidance for Industry (Sept. 2016).
The guidance updates food product categories for both human food and animal feed. While most FDA guidance documents contain informal recommendations, this guidance contains findings that serve as the predicates for binding requirements on industry.
FDA issued the revised guidance in accordance with section 102 of FSMA, and food companies will be required to select appropriate food product categories from the updated categories during the October – December 2016 registration renewal period. The guidance also describes certain FSMA amendments that allow the FDA to determine appropriate food product categories through guidance.
Updates include:
- Acidified foods and low acid canned foods are no longer listed as food product categories because they are now activity types.
- Additions to animal food categories of botanicals and herbs, direct fed microbials, animal protein products, forage products, human food by-products not otherwise listed, and technical additives. (The “animal protein products” category replaces the previous “animal derived products” category, and the “processed animal waste products” category replaces the “recycled animal waste products” category.)
- Molluscan shellfish is now a food product category (previously, molluscan shellfish establishment was listed among the optional activity types).
Comments on the guidance may be submitted to FDA at any time.
