FDA Seeks to Mow Down Lawsuit Over GRAS

By Ricardo Carvajal –

FDA filed a motion to dismiss the lawsuit brought by the Center for Food Safety challenging the legality of FDA’s GRAS notification program (for background information on the lawsuit, see our prior posting here).  In its supporting memorandum, FDA argues that plaintiff lacks standing and that the agency’s proposed rule on GRAS notification is not final agency action subject to judicial review.  FDA further argues that plaintiff’s action is barred by the applicable statute of limitations.

FDA’s supporting memorandum points to the several advantages of the GRAS notification program as compared with the GRAS affirmation program it replaced, including increased efficiency and greater participation by industry.   FDA notes that a return to GRAS affirmation would merely trade one voluntary mechanism for another, and would not achieve the gatekeeping function sought by plaintiff.   FDA indicates that it intends to clear the final rule on GRAS notification by July 2016.   We’ll continue to monitor and report on significant developments in this case.