“GRAS” is an acronym for the phrase “Generally Recognized as Safe.” Under sections 201(s)
and 409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), any substance that is
intentionally added to food is a food additive, that is subject to premarket review and approval
by FDA, unless the substance is generally recognized, among qualified experts, as having been
adequately shown to be safe under the conditions of its intended use, or unless the use of the
substance is otherwise excepted from the definition of a food additive.2 Sections 201(s) and 409
were enacted in 1958 as part of the Food Additives Amendment to the FD&C Act. FDA has
several lists of substances that are used in food on the basis of the GRAS provision.
