In blog post published on September 14, 2018, by the U.S. non-governmental organization (NGO) Environmental Defense Fund (EDF), chemicals policy director Tom Neltner gave an update on the NGO-lawsuit against the U.S. Food and Drug Administration (FDA) regarding the final GRAS (Generally Recognized as Safe). In August 2016, the FDA published a final rule setting the criteria for determining that the use of a food additive is ‘generally recognized as safe’ (FPF reported). This rule may also apply to substances in food contact materials (FCMs) that can become indirect additives to food. In May 2017, several U.S. NGOs filed a law suit challenging the final GRAS rule because it “allows food manufacturers to make secret GRAS safety determinations for chemicals added to food, without notifying FDA or the public, and to use the chemical in food without anyone else’s knowledge,” Neltner explained (FPF reported).

In response to the law suit, the FDA submitted a motion to dismiss the NGO’s case to a federal district court. However, the court ruled that the NGOs’ claim to challenge the GRAS rule was justified and the law suit may thus continue. “We are pleased that the court ruled in our favor in this crucial first step,” Neltner stated. With this court decision, we are one step closer to correcting . . . [FDA’s] failure and achieving a safer food supply,” he added. Further, he referred to the recent American Academy of Pediatrics’ reports on food additives and child health that call on FDA “to greatly strengthen or replace the GRAS determination process” (FPF reported).

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Tom Neltner (September 14, 2018). “Challenge to FDA’s GRAS rule moves forward after court rejects request for dismissal.EDF Heatlh

Kelly Franklin (September 21, 2018). “Legal challenge of U.S. food additives rule will move forward.Chemical Watch