A substance that will be added to food is subject to premarket approval by FDA unless its use is generally recognized as safe (GRAS) by qualified experts.(1) On April 17, 1997, FDA issued a proposed rule (the GRAS proposal; 62 FR 18938) that would establish a notification procedure whereby any person may notify FDA of a determination by that person that a particular use of a substance is GRAS. Although the proposed notification procedure is not yet final, FDA has already received several notices. As described in the GRAS proposal, the agency is evaluating whether each submitted notice provides a sufficient basis for a GRAS determination and whether information in the notice or otherwise available to FDA raises issues that lead the agency to question whether use of the substance is GRAS. Following this evaluation, FDA responds to the notifier by letter.