The FDA recently issued a draft Guidance identifying additional categories of food from which food companies will be required to select when completing their facility registrations. Importantly, because the statute authorize FDA to create these categories “through guidance,” once FDA finalizes this Guidance document it will be binding on companies. Regular readers of FDA Guidance documents (or our Alerts summarizing them) know that they typically state that they represent FDA’s current thinking but are not binding. The new food categories will be binding, however, once the Guidance is final.

The Guidance further implements provisions of the Bioterrorism Act from 2002 and Food Safety Modernization Act of 2011 to protect the nation’s food supply. The Guidance states that “FDA believes that information about a facility's food categories is a key element to allow for rapid communications between FDA and facilities directly impacted by actual or potential bioterrorist attacks, other food-related emergencies, or food safety incidents.”

With respect to food intended for human consumption, the Guidance will add the following categories to the registration process:

  • Acidified Food (see 21 CFR 114.3(b));
  • 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;
  • Fisher/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
  • Baby (Infant and Junior) Food Products Including Infant Formula.

In addition, the draft Guidance adds several categories of food for animal consumption, most of which it notes are already included as options.