Center for Food Safety v. Becerra

The Food Additives Amendment to the Food, Drug, and Cosmetic Act (FDCA) required food manufacturers to obtain approval from the Food and Drug Administration (FDA) before using any “food additive” in food. The statutory definition of “food additive” excluded substances generally recognized as safe (GRAS) for use in food. In 1997, the FDA promulgated a proposed GRAS rule that allowed—but did not require—food manufacturers to notify the FDA that the manufacturer had independently determined that a substance was GRAS. If the FDA disagreed with a manufacturer’s GRAS determination, the FDA could take enforcement action against the manufacturer. The FDA promulgated the final GRAS rule with minimal changes in 2016. The FDA decided not to require mandatory GRAS notifications based on (1) the FDCA’s exemption of GRAS substances from the food-additive approval requirements, (2) the FDA’s observation that manufacturers had continued to submit GRAS notifications even though the process was voluntary, and (3) the FDA’s desire to focus agency resources on reviewing higher-priority substances. However, because the final GRAS rule did not require food manufacturers to notify the FDA about GRAS determinations, concerns arose that food manufacturers were selling products containing substances that the manufacturers had independently concluded were safe without FDA oversight. The Center for Food Safety and the Environmental Defense Fund (collectively, the advocacy groups) (plaintiffs) brought an action against Xavier Becerra and other federal officials (collectively, the officials) (defendants) to challenge the GRAS rule. The advocacy groups contended, among other things, that the GRAS rule (1) unlawfully subdelegated to manufacturers the FDA’s duty to ensure food safety and (2) violated the Administrative Procedure Act (APA). The parties cross-moved for summary judgment.