GRAS affirmation is a process that FDA developed in the 1970s. In response to concerns raised
by new information on cyclamate salts, then-President Nixon directed FDA to re-examine the
safety of substances considered to be GRAS. FDA announced that the agency would evaluate,
by contemporary standards of the time, the available safety information regarding substances
considered to be GRAS. If the re-evaluations confirmed that the uses were GRAS, FDA
promulgated new GRAS regulations, affirming those findings. FDA also established procedures
whereby an individual could voluntarily petition FDA to review the GRAS status of substances
that would not have been considered as part of the agency’s GRAS review.
In a final rule that FDA published on August 17, 2016 (81 Fed. Reg. 54960), FDA removed that
voluntary process from its regulations and replaced it with a voluntary GRAS notification
procedure.
