Member Symposium
Science Policy
David Edwards
Director, Division of Animal Food Ingredients
U.S. Food and Drug Administration
Rockville, Maryland
Austin Therrell
AAFCO
Champaign, Illinois
In the United States, substances intended for use in animal diets are generally considered to be either animal foods or animal drugs. The regulatory classification of a substance relies on its intended use. The Center for Veterinary Medicine (CVM) at the United States Food and Drug Administration regulates animal food substances.
Any substance intentionally added to an animal food must be either an approved food additive as listed in part 573 in Title 21 of the Code of Federal Regulations (21 CFR 573) or a substance that is generally recognized as safe (GRAS) for an intended use, including those listed in 21 CFR 582, 584 and the CVM GRAS Notice Inventory. Also, in coordination with state feed control officials, CVM recognizes ingredients in the Official Publication of the Association of American Feed Control Officials (AAFCO) as being acceptable for use in animal foods.
Currently listed (or soon to be listed) insects for use in animal food have utilized the AAFCO ingredient definition process: Black Soldier Fly Larvae-source of protein and fat for salmonid, poultry, swine, and dogs; black soldier fly larvae oil-energy source for swine, finfish, dog, and cats, and mealworms-source of protein for dogs.
CVM is available to provide written feedback on protocols to ensure data from feeding studies will meet regulatory needs. This feedback will include what endpoints and parameters to be measured will support a submission to the agency. Additional guidance documents on pre-submission and submission procedures are available.