FDA Fights to Have GRAS Lawsuit Dismissed

The U.S. Food and Drug Administration has filed a motion to dismiss a lawsuit against them regarding a proposed rule on substances generally recognized as safe (GRAS). The 46-page motion, dated May 14, 2014, was filed with the U.S. District Court for the District of Columbia.  The Center for Food Safety (CFS) suit filed in February calls on the agency to vacate its never-finalized rule from 1997, which replaces the traditional petitioning process for a manufacturer seeking GRAS status for an additive, with a “procedure whereby any person may notify FDA of a determination that a particular use of a substance is GRAS.”  “Although Plaintiff notes that years have passed since the issuance of the proposal and acknowledges, as it must, that FDA has not actually ‘promulgate[d] a final rule,'” FDA states in the memorandum.  The arguments for dismissal FDA puts forward are that CFS has not identified any member “who has actually suffered this clearly speculative injury” and that “the proposed rule does not cause the alleged injuries from consumption of food substances.”  In addition, the agency argues that the rule is not “final agency action” and therefore is “not subject to judicial review.”  The document also states that FDA plans to clear the final rule by July 2016.