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Consumer Groups File Complaint Against FDA for GRAS Final Rule
07 June 2017
On May 22, 2017, the Center for Food Safety (CFS), Breast Cancer Prevention Partners (BCPP), Center for Science in the Public Interest (CSPI), and Environmental Defense Fund (EDF), filed a complaint for declaratory and injunctive relief against the U.S. Food and Drug Administration (FDA) for the agency’s final rule regarding substances that are Generally Recognized as Safe (GRAS) for use in human and animal foods (the Final Rule).
The Plaintiffs take issue with the voluntary nature of the GRAS notice program and allege the Final Rule is an “unlawful[ ] sub-delegation of authority,” an arbitrary and capricious agency action, and an abdication of statutory duty that violates the Administrative Procedure Act (APA) and the Federal Food, Drug, and Cosmetic Act (FFDCA).
By way of brief background, on August 17, 2016, FDA published the Final Rule to comply with a consent decree with CFS from another lawsuit that claimed the agency violated the APA by “indefinitely operating under a proposed rule in lieu of promulgating a final rule.” The Final Rule clarified the criteria for when the use of a substance is GRAS and exempt from premarket approval requirements of the FFDCA for food additives. It also finalized the administrative procedure for any person to voluntarily notify FDA the basis of a conclusion that a substance is GRAS.
Authored by Martin Hahn, Joe Levitt, and Xin Tao.
Washington, D.C.
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