Not necessarily. Under section 201(s) of the FD&C Act, it is the use of a substance, rather than
the substance itself, that is eligible for classification as GRAS (81 Fed. Reg. 54960 at 54963;
August 17, 2016). An evaluation of the safety of the use of an ingredient includes information
about the characteristics of the substance, the estimated dietary exposure under the intended
conditions of use, and the population that will consume the substance. Dietary exposure to a
substance depends on the food categories in which it will be used and the level of use in each
of those food categories. For information about how CFSAN estimates human dietary exposure
to a food substance, see CFSAN’s document entitled “Estimating Dietary Intake of Substances
in Food” (Ref. 1).
Some uses of a human food substance are intended for a narrowly defined population. For
example, some human food substances are intended for consumption by newborn infants who
consume infant formula as the sole item of the diet; in such a circumstance, there may be
special considerations associated with that population but not with general use of the food
substance. Likewise, some substances intended for use in animal food are intended for specific
animal species (such as cattle or swine), or for a specific life stage of an animal species; a
substance that is safe for use in one animal species may not be safe for use in another species
or in the same species at a different stage of life.
