Briefly, under the GRAS Rule,1 FDA reviews voluntary submissions that conclude a substance is generally recognized as safe (GRAS) for use in food under the conditions of its intended use and is thus not subject to the premarket approval requirements for food additives as set forth in section 409 of the Federal Food, Drug, and Cosmetic Act (FDCA). FDA published the GRAS Rule in 2016 to comply with a consent decree with the Center for Food Safety (CFS) from a lawsuit that claimed the agency violated the Administrative Procedure Act (APA) by “indefinitely operating under a proposed rule in lieu of promulgating a final rule.”2 The GRAS Rule clarified the criteria for when the use of a substance is GRAS and exempt from premarket approval requirements of the FDCA 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.
On May 22, 2017, the CFS, Breast Cancer Foundation, Center for Science in the Public Interest, Environmental Defense Fund, and Environmental Working Group (NGOs) sued the FDA seeking a declaratory judgment that the GRAS Rule (1) violates fundamental principles of separation of powers; (2) exceeds FDA’s statutory authority; (3) does not accord with the law; (4) is arbitrary and capricious; and (5) is an abuse of discretion.3 The complaint focused on the NGOs’ perceived shortcomings of the GRAS Rule, that it is a non-transparent process that improperly delegates FDA’s duty to evaluate food additives to industry and conflicts of interest arise when GRAS substances are evaluated by third parties rather than by FDA.
On March 26, 2019, the NGOs moved for summary judgment, stating that the “the GRAS Rule (1) unlawfully subdelegates FDA’s duty to ensure food safety in violation of the United States Constitution, the APA, and the FDCA; (2) exceeds FDA’s statutory authority and constitutes arbitrary and capricious agency action in violation of the FDCA and APA; and (3) conflicts with the FDCA.” FDA responded with a cross motion for summary judgment, arguing that the GRAS Rule is a proper exercise of FDA’s authority under the FDCA and is not unconstitutional.
District Judge Vernon S. Broderick granted FDA’s motion on September 30, 2021,4 and denied that of the NGOs, upholding the current GRAS framework. He responded to each of the NGOs’ arguments.
FDA has not improperly delegated any duty to manufacturers because FDA retains its authority to agree or disagree with self-GRAS determinations and intervene with an enforcement action for foods that are not GRAS.
The FDCA can reasonably be construed to permit a voluntary notification program and allow FDA to act after violations have occurred. FDA may not have the authority under the FDCA to institute a mandatory GRAS notification program.
FDA properly justified its decision to implement the GRAS Rule and properly went through the necessary rulemaking procedures required under the APA.
The GRAS Rule provisions do not conflict with the FDCA. In particular, the FDCA does not prohibit reliance in part on unpublished materials when considering GRAS status, and the FDCA is silent on how conflicts of interest must be addressed.
The changes the NGOs seek lie in Congress, not the courts.
The NGOs have 60 days from September 30, 2021, to appeal; it is not clear at this point whether the NGOs will appeal. Hogan Lovells will continue to closely follow this lawsuit and developments related to the GRAS Rule. Please do not hesitate to reach out to us if you have any questions regarding this or other matters.
1 81 Fed. Reg. 54960 (Aug. 17, 2016).
2 Center for Food Safety v. Burwell, Case No. 1:14-cv-267-RC, Consent Decree, ECF No. 14-1 (Oct. 20, 2014).
3 Complaint at 34–36, Center for Food Safety, No. 1:17-cv-03833-VSB.
4 Center for Food Safety v. Price, No. 1:17-cv-03833-VSB (S.D.N.Y. Sept. 30, 2021).
Authored by Martin Hahn, Xin Tao, and Connie Potter.