The GRAS notification procedure is a voluntary procedure under which any person may notify
FDA of a conclusion that a substance is GRAS under the conditions of its intended use in
human food (21 CFR part 170, subpart E) or animal food (21 CFR part 570, subpart E).
Although the GRAS notification procedure is voluntary, FDA strongly encourages any person
4 Note that FDA previously published a notice in the Federal Register explaining its conclusion that the
Dietary Supplement Health and Education Act of 1994 (which established the exception from the
definition of “food additive” in section 201(s) of the FD&C Act for a dietary ingredient of a dietary
supplement) does not apply to products intended for use in animals (61 Fed. Reg. 17706; April 22, 1996). 5 “Dietary ingredient” is defined in section 201(ff)(1) of the FD&C Act and generally includes vitamins,
minerals, herbs and other botanicals, amino acids, dietary substances, and concentrates, metabolites,
constituents, extracts, and combinations of dietary ingredients in the other categories. who intends to market a food substance on the basis of the GRAS provision to submit a GRAS
notice to FDA.
A GRAS notice has seven required parts as shown in Table 3 for a substance intended for use
in human food and as shown in Table 4 for a substance intended for use in animal food.
