Yes. Because the use of a substance that is GRAS is not subject to premarket review and
approval by FDA, it is impracticable to list all substances that are used in food on the basis of
the GRAS provision (21 CFR 182.1(a) and 21 CFR 582.1(a)). The use of a substance is GRAS
because of widespread knowledge among the community of qualified experts, not because of a
listing or other administrative activity.
