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Settlement Reached in GRAS Lawsuit Against FDA

The U.S. Food and Drug Administration (FDA) has agreed to finalize its rule for the process of determining food substances as “generally recognized as safe” (GRAS).

The decision is part of a settlement agreement with the Center for Food Safety (CFS), which sued the agency last February, seeking to vacate FDA’s 1997 proposed rule on 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.” FDA’s website acknowledges that the agency began accepting GRAS notices in 1998 even though the procedure was not yet final.

In May, FDA filed a motion to dismiss the suit, arguing that CFS has not identified any member of the organization “who has actually suffered this clearly speculative injury” and that “the proposed rule does not cause the alleged injuries from consumption of food substances.”

The settlement agreement, pending approval by the court, will require FDA to finalize the GRAS rule by August 2016.  If FDA does not meet this deadline, CFS can ask the court to order the agency to fulfill its commitment and issue the rule.

“This is a major victory for consumers and the public,” said Donna Solen, CFS senior attorney. “For more than 17 years, FDA has imposed a lax regulatory system on consumers without affording them their right to participate in the rulemaking process. This is a violation of federal law that will come to an end as a result of this settlement agreement.”

The Natural Resources Defense Council (NRDC) has previously estimated that about 1,000 of the 10,000 additives used in food today are being used based on undisclosed GRAS safety determinations. A recent report from the organization explored more details about chemicals reported as GRAS based solely on a company determination.

In August, the Grocery Manufacturers Association announced its plan to make the process for companies’ GRAS determinations more transparent.

Although the matter of this particular FDA rule may be settled, conversations surrounding GRAS are unlikely to die down.

Speaking to reporters at the United Fresh Washington Conference in September, Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, said that the agency would like to do more to ensure that it can vouch for the safety of GRAS substances, but that there are “some big resource constraints.”

“Post-market surveillance is something we think is necessary and needs to be enhanced for both food safety and consumer confidence perspectives,” Taylor said, adding that although FDA’s food additive program has been funded to do the market-entry work, it “hasn’t really been funded to do the post-market surveillance.”

© Food Safety News
  • O_Scotty

    GMA and “transparency”; isn’t that an oxymoron?