FDA Seeks New Comments on 1997 Proposed Changes to GRAS Rule

The Food and Drug Administration (FDA) has reopened the comment period
on revisions proposed in 1997 to its rule regarding substances generally
recognized as safe (GRAS). Written or electronic comments are requested by
March 28, 2011.

The proposed revisions would “replace the voluntary GRAS affirmation petition process . . . with a voluntary notification procedure whereby any person may notify us of a determination that a particular use of a substance in human food . . . or in food for animals . . . is GRAS.” The proposal would also “clarify the criteria . . . whereby the use of a substance is not subject to the premarket approval requirements of the [Food, Drug, and Cosmetic Act] because it is GRAS.” The Federal Register notice refers to several developments since 1997, including the use of nanotechnology in foods, a Government Accountability Office (GAO) report on FDA oversight of GRAS foods and the agency’s experience with the notification procedures during an interim period. Additional information about the GAO report appears in Issue 341 of this Update.

In light of these intervening developments as well as comments already received, FDA seeks comments on particular aspects of the proposal. Among them are (i) the use of certain terms and definitions such as “scientific procedures”; (ii) whether submissions should exclude non public information, given their availability for public disclosure; (iii) the inclusion of additional information about engineered nanomaterials; (iv) whether submissions for substances to be used in the food of an animal used to produce human food should include information about target animal and human safety; and (v) how to address substances intended for use in products under the U.S. Department of Agriculture’s jurisdiction. Comments previously submitted should not be resubmitted. See Federal Register, December 28, 2010.