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Federal Court Upholds GRAS Rule

Stacks of binders of regulations

On September 30, 2021, the U.S. Food and Drug Administration (FDA) prevailed in the federal lawsuit brought by the Center for Food Safety and the Environmental Defense Fund challenging FDA’s final rule, titled, Substances Generally Recognized as Safe. The U.S. District Court for the Southern District of New York granted FDA’s motion for summary judgment and rejected all causes of action asserted by the plaintiffs. Specifically, the plaintiffs argued that the Generally Recognized as Safe (GRAS) Rule unlawfully subdelegates FDA’s authority to the food industry, exceeds FDA’s statutory authority and constitutes arbitrary and capricious rulemaking under the Administrative Procedure Act (APA), and is otherwise in conflict with the Food, Drug, and Cosmetic Act. Devon Keller and Heckman’s Partners Devon Wm. Hill and Eric Gotting filed an amicus curiae brief in support of the GRAS Rule on behalf of the Safe Food Ingredients Coalition. The court cited the amicus brief on several occasions in support of its decision.

Having lost at the District Court, the plaintiffs have 28 days from the entry of final judgment to file a motion to alter or amend the judgment or 60 days to file an appeal with the United States Court of Appeals for the Second Circuit. 

More information on the federal court’s ruling can be found here.

More information on the GRAS Rule, can be found here.