FDA has premarket review authority over food additives; however, substances that are generally recognized as safe (GRAS) are not legally considered “food additives” as that term is defined under the Federal Food, Drug and Cosmetic Act, and therefore are not subject to the premarket clearance requirements that apply to other substances used in or in contact with food. Until August 2016, FDA operated a voluntary GRAS Notification Program provided for under a 1997 proposed rule. On August 12, 2016, FDA released a final rule formalizing its GRAS Notification program and detailing the criteria for concluding that the use of a substance in human or animal food is “generally recognized as safe” (GRAS). See previous blog coverage here. In addition, companies also have the option to self-determine that a substance is GRAS without notifying the FDA of its conclusion.
Yesterday, a group of NGOs sued FDA challenging the legality of the final GRAS rule. The lawsuit – filed by the Center for Food Safety, Breast Cancer Prevention Partners, Center for Science in the Public Interest, Environmental Defense Fund, and the Environmental Working Group – recites many of the prior concerns voiced by the NGO community with respect to substances that companies self-determine are GRAS. In particular, the lawsuit alleges that FDA is required to review the safety of a substance before it can be used in or in contact with food, and that the Agency has therefore failed to meet its duty by not reviewing the safety of substances that companies self-determine are GRAS, noting that some self-determined GRAS substances should be considered “food additives-in-fact” and on that basis are subject to premarket review under the food additive regulatory framework. The NGOs request that the Court:
(1) declare the final GRAS regulation to be unlawful and
(2) vacate the final GRAS regulation so that it can be re-promulgated by FDA in accordance with the NGOs’ views.
We will keep a close eye on developments in this case as they unfold and report them to you here.