[1][3] On August 31, 1960, William W. Goodrich, assistant general counsel of the FDA, addressed the annual meeting (16 Bus.
The purpose of the meeting was the forthcoming March 6, 1961, effective date of the enforcement provisions of the "Food Additives Amendment of 1958", referred to as GRAS.
[4] The Code of Federal Regulations, revised as of April 1, 2020[update],[7] includes (CFR) title 21 170.30(b) that provides general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence needed to obtain approval of the substance as a food additive.
[2] For new proposals, the proponent of the exemption – usually a food manufacturer or ingredient supplier wishing to highlight a food ingredient in its manufactured product – has the burden of providing rigorous scientific evidence that use of the substance in an edible consumer product is safe.
[2] When use of a substance does not qualify for the GRAS exemption, it is subject to the premarket approval mandated by the Federal Food, Drug, and Cosmetic Act.