The Center for Food Safety (CFS) recently filed a lawsuit against the U.S. Food and Drug Administration (FDA) over the FDA’s regulation of food additives and its Generally Recognized as Safe (GRAS) program.  According to the suit, the FDA has relied on a proposed rule over the last 15 years that has allowed food manufacturers to determine whether a food additive is safe enough to be included on the agency’s list of “generally recognized as safe” ingredients. Ingredients not on the GRAS list require agency approval before they can be used in food. This proposed rule was not final when the FDA began accepting GRAS notices in 1998 and it still has not been finalized today.

In the complaint, the CFS asks the court to vacate the proposed rule and require that the FDA apply the previous GRAS rule. The previous rule required manufacturers to formally petition the FDA for approval of a new food additive as GRAS, and to support such a request with published studies. This petition process also required the FDA to notify the public and provide opportunity for comment before approving the additive’s use. According to the suit, the FDA’s conduct of relying on a proposed rule “indefinitely”—and not considering and responding to public comments in the process of finalizing the rule—violates the rule-making requirements of the Administrative Procedure Act.

The FDA states on its website that the agency evaluates GRAS notices and determines whether there is any information that raises questions about a substance’s GRAS status. But the CFS claims that the FDA does not truly evaluate the data and no longer confirms that a GRAS substance is actually safe. The lawsuit also references a 2010 report from the U.S. Government Accountability Office that reached a similar conclusion, finding that “companies may determine a substance is GRAS without FDA’s approval or knowledge.”

According to the complaint, there are several additives currently on the GRAS list that pose serious health risks to consumers. Examples of unsafe additives include volatile oil of mustard (which may contain a potential carcinogen), the fat-substitute olestra (which has allegedly caused GI problems in consumers), and a fungus-based meat substitute mycoprotein (which may cause dangerous allergic reactions).

The case is Center for Food Safety v. Kathleen Sebelius, Secretary of U.S. Department of Health and Human Services, case number 1:14-cv-267, in the U.S. District Court for the District of Columbia.

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