Lawsuit Brought Against FDA Regarding Food Additives

Food Safety News

By Lydia Zuraw | February 21, 2014

After settling a dispute about final rule deadlines for the Food Safety Modernization Act (FSMA) earlier this week, the Center for Food Safety (CFS) has filed another lawsuit against the U.S. Food and Drug Administration – this time over food additives.
The suit seeks to vacate FDA’s 1997 proposed rule on substances generally recognized as safe (GRAS). The rule 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.”
CFS wants the agency to return to the traditional process by which manufacturers formally petition FDA to approve a new food additive as GRAS based on published studies.
FDA’s website acknowledges that the agency began accepting GRAS notices in 1998 even though the procedure was not yet final (and has yet to be finalized) and states that “the agency is evaluating whether each submitted notice provides a sufficient basis for a GRAS determination and whether information in the notice or otherwise available to FDA raises issues that lead the agency to question whether use of the substance is GRAS.”

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