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Federal court upholds legality of GRAS self-determinations

The U.S. FDA and the food industry shared a victory as a federal judge dismissed a suit seeking to find unlawful the process by which companies have been allowed to determine, without notification to FDA, that a food or supplement ingredient is Generally Recognized as Safe (GRAS). Such self-determinations, in use for more than six decades, can exempt substances from pre-market review by FDA and had drawn the ire of (and a lawsuit from) the Center for Science in the Public Interest and the Environmental Working Group. Among other complaints, the lawsuit claimed that self-GRAS evaluations unlawfully subdelegate FDA’s duty to ensure food safety, exceed the FDA’s statutory authority, and violate the Federal Food, Drug, and Cosmetics Act. The decision by Judge Vernon Broderick, of the Southern District Court of New York, effectively ends the litigation (although further appeal is possible), leaving the self-GRAS regulatory framework in place.