The United States District Court for the Southern District of New York last week entered summary judgment in favor of the United States Food and Drug Administration (FDA) in a suit filed in 2017 that sought to overturn FDA’s allowance for the GRAS self-affirmation process commonly used to document the safety of new food ingredients.
Referred to in the lawsuit as “the GRAS Rule,” this regulation is codified at 21 C.F.R. §§ 170.203 et seq. and lays out the procedure under which parties may notify FDA of their conclusion through self-affirmation that a substance is generally recognized as safe (GRAS) under the conditions of its intended use. The final rule was issued on August 17, 2016,1 and established a voluntary—rather than a mandatory procedure—for notifying FDA of GRAS determinations.
The suit was originally filed by five advocacy organizations, three of whom were subsequently removed when FDA challenged their standing to bring the suit. The court’s decision therefore identified only the Center for Food Safety and the Environmental Defense Fund as plaintiffs.
The plaintiffs made numerous allegations and claims for relief in their 2017 complaint: that the rule unlawfully subdelegates FDA’s statutory authority to private parties; that “the secret GRAS system” is contrary to the Food, Drug, and Cosmetic Act (FDCA) and exceeds FDA’s statutory authority; and that the rule is arbitrary and capricious in violation of the FDCA and the Administrative Procedures Act.
U.S. District Judge Vernon Broderick rejected each of these allegations and claims in an Opinion and Order issued on September 30, 2021, and the accompanying Judgment declared the case to be closed.
“This is an important decision that protects a regulatory option that many responsible suppliers use to bring safe ingredients to the U.S. market,” commented Michael McGuffin, AHPA President.
The plaintiff organizations have the option of filing an appeal of the decision. AHPA will continue to monitor this case in the event of further proceedings.
The case is 1:17-cv-03833-VSB. Click here to see Judge Broderick’s detailed Opinion and Order.
81 Fed. Reg. 54,960.