Under section 201(s) of the FD&C Act, a substance that is GRAS under the conditions of its
intended use is excluded from the definition of a food additive. In addition, under section 201(s)
of the FD&C Act the term “food additive” does not include a dietary ingredient used or intended
for use in a dietary supplement as defined in section 201(ff) of the FD&C Act. In other words,
because dietary ingredients intended for use in dietary supplements are already excepted from
the food additive definition, their GRAS status for that use is irrelevant because they are already
exempt from the food additive approval requirement. However, some dietary ingredients that
may be used in a dietary supplement may also be GRAS for use in a conventional food (e.g.,
vitamin C; calcium carbonate). In addition, a substance that is not a dietary ingredient as
defined in section 201(ff)(1) of the FD&C Act must be approved as a food additive when used in
a dietary supplement (e.g., as a coating, filler, or binder) unless the substance is GRAS for that
use or otherwise excepted from the definition of a food additive.
