Explore related questionsWhile the earlier announcement focused on eliminating self-affirmed GRAS, the new proposal takes a different approach by making GRAS notifications mandatory. Acting FDA Commissioner Kyle Diamantas said the proposal would require companies introducing a new GRAS substance or new use to notify FDA of the basis for their conclusion. “By proposing mandatory GRAS notifications, we are closing critical information gaps and giving FDA greater visibility into the substances in our food supply,” Diamantas said. He added that the GRAS pathway was intended to provide an exemption from the otherwise required premarket approval process. Legal authority could be challengedThe proposal could also face scrutiny over FDA’s authority to make GRAS notifications mandatory.