ettling 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.”
But CFS claims that “FDA no longer conducts its own detailed analysis to evaluate the data” and “no longer affirms whether or not a substance’s use is GRAS at all.”
A 2010 Government Accountability Office (GAO) report on the subject passed similar judgment by stating, “Currently, companies may determine a substance is GRAS without FDA’s approval or knowledge.”
CFS is particularly concerned that this notification process has allowed for potentially hazardous additives to enter the food supply. Three examples named in the lawsuit are a potential human carcinogen called Volatile Oil of Mustard, an indigestible compound called Olestra that can cause adverse reactions, and a fungus-based meat substitute mycoprotein (also know as Quorn) that can cause dangerous allergic reactions.
“It has been 15 years since FDA handed authority to determine GRAS status over to the corporations it is meant to regulate,” said Andrew Kimbrell, CFS executive director. “FDA has an obligation to provide the regulatory scrutiny the public deserves.”
