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FDA Finalizes Guidance on Food Product Categories on Facility Registrations

The Food and Drug Administration formally announced the availability of its final guidance on the “Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories” in a notice set for publication in the Oct. 24 Federal Register. The guidance was issued Oct. 19, in conjunction with the beginning of food facility registration renewal. The guidance includes FDA’s determination that information about food product categories in food facility registrations is necessary for a quick, accurate, and focused response to a food safety related issue or incident, an actual or potential bioterrorist incident, or other food-related emergency, and identifies the additional food product categories included as mandatory fields in food facility registrations, as follows:

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Additional Food Product Categories for Foods for Human Consumption:

  • Acidified Food (see 21 CFR 114.3(b));
  • Baby (Infant and Junior) Food Products Including Infant Formula*;
  • Cheese and Cheese Product Categories: Soft, Ripened Cheese; Semi-Soft Cheese; Hard Cheese; Other Cheeses and Cheese Products;
  • Dietary Supplement Categories: Proteins, Amino Acids, Fats and Lipid Substances; Animal By-Products and Extracts; Herbals and Botanicals;
  • Fishery/Seafood Product Categories: Fin Fish, Whole or Filet; Shellfish; Ready to Eat(RTE) Fishery Products; Processed and Other Fishery Products;
  • Fruit and Fruit Products: Fresh Cut Produce; Raw Agricultural Commodities; Other
  • Fruit and Fruit Products;
  • Fruit or Vegetable Juice, Pulp or Concentrate Products;
  • Low Acid Canned Food (LACF) Products (see 21 CFR 113.3(n));
  • Nuts and Edible Seed Product Categories: Nut and Nut Products; Edible Seed and Edible Seed Products;
  • Shell Egg and Egg Product Categories: Chicken Egg and Egg Products; Other Egg and Egg Products;
  • Vegetable and Vegetable Product Categories: Fresh Cut Products; Raw Agricultural Commodities; Other Vegetable and Vegetable Products; and
  • If none of the human food categories listed in the registration form apply, print the applicable food category or categories.

Additional Food Product Categories for Foods for Animal Consumption:

  • Grain or Grain Products (i.e., barley, grain sorghums, maize, oat, rice, rye, wheat, other grains or grain products)*;
  • Oilseed or Oilseed Products (i.e., cottonseed, soybeans, other oilseeds or oilseed products)*;
  • Alfalfa Products or Lespedeza Products*;Amino Acids or Related Products*;
  • Animal-Derived Products*;
  • Brewer Products*;
  • Chemical Preservatives*;
  • Citrus Products*;
  • Distillery Products*;
  • Enzymes*;
  • Fats or Oils*;
  • Fermentation Products*;
  • Marine Products*;
  • Milk Products*;
  • Minerals or Mineral Products*;
  • Miscellaneous or Special Purpose Products*;
  • Molasses or Molasses Products*;
  • Non-protein Nitrogen Products*;
  • Peanut Products*;
  • Recycled Animal Waste Products*;
  • Screenings*;
  • Vitamins or Vitamin Products*;Yeast Products*;
  • Mixed Feed (e.g., poultry, livestock, equine)*;
  • Pet Food*;
  • Pet Treats or Pet Chews;
  • Pet Nutritional Supplements (e.g., vitamins, minerals); and
  • If none of the above food categories apply, print the applicable food category or categories (that does not or do not appear above).

*Previously included on the food facility registration form as an optional field.

FDA's guidance is available here.

(See ITT's Online Archives 12102221 for summary of the opening of FDA registration renewal, which is required for all food facilities, even those that have already registered, every two years. This year's registration runs until Dec. 31.)