One of the conditions which a drug must fulfill if it is not to be considered as a new drug: or a food must fulfill if it is not to be considered as a food additive. A drug which is GRAS and GRAE need not go through the pre-market approval procedures prescribed in the Federal Food, Drug, and Cosmetic Act for new drugs. General recognition of safety of a drug must be “among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs”, and to acquire general recognition of safety and effectiveness a drug must be ”used to a material extent or for a material time.”
Any additive approved for use in foods must be generally recognized as safe as determined by the Food and Drug Administration (FDA).