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FDA Issues New Form to Facilitate Submission of GRAS Notifications

Recently, the U.S. Food and Drug Administration (FDA) made available a new standardized form to facilitate the submission of Generally Recognized as Safe (GRAS) Notifications for human food. GRAS Notification Form 3667 is intended to assist with the assembly and transmittal of a GRAS Notification. It is not intended to replace the existing GRAS Notification form; rather, it is an organizational document that serves as an extended cover sheet for a complete GRAS Notification. Instructions on how to complete the new form are available on FDA's website.

By way of background, FDA first proposed the GRAS Notification procedure in a Proposed Rule published on April 17, 1997 (62 Fed. Reg. 18938-18964). While the proposed notification procedure is not yet the subject of a Final Rule, the Agency started accepting GRAS notifications in 1998. After evaluating a GRAS notice, FDA responds to the Notifier by written correspondence. Generally, FDA either: 1) does not question the basis for the Notifier's GRAS determination; 2) determines that the notice does not provide a sufficient basis for a GRAS determination; or ceases to evaluate the GRAS notice at the Notifier's request. FDA requested further comments on the proposed 1997 GRAS Notification procedure in December 2010.

FDA maintains an inventory of GRAS notices that includes both pending notices and ones that have come to closure, regardless of the nature of the Agency's response.