FDA Opens Feedback Period for GRAS Notification Proposed Rule

January 18, 2011

The rule could change the procedure for "self-affirmed" Generally Recognized as Safe (GRAS) status.

FDA is reopening the comment period for a 1997 proposed rule on Generally Recognized as Safe (GRAS) notification procedures, according to a news update in the Federal Registry.

The proposed rule would replace the current “self-affirmed GRAS” petition with a voluntary notification procedure. The full language can be read here.

The 1997 rule was not ultimately finalized although FDA did implement a procedure based on the proposed rule. It has been used for GRAS-affirmation of human foods.

All comments must be submitted for March 28, 2011. FDA will consider submitted comments in addition to comments from the previous feedback period, a 2010 Government Accountability Office report, and an FDA memorandum on up-to-date experience with the current GRAS notification procedure.