The GRAS (Generally Recognized As Safe) process, by which companies establish the safety of an ingredient under the conditions of intended use and may notify the U.S. Food and Drug Administration about this self-affirmation, was recently targeted in a lawsuit that reached the U.S. District Court for the Southern District of New York.
 
However, the case was dismissed in favor of the GRAS determination process, which has become an industry standard since a final rule declaration which occurred in 2016 to establish the voluntary process by which companies can notify the FDA.
 
According to the trade association AHPA (American Herbal Products Association), the suit was originally filed by five advocacy associations, but three of these organizations were removed when FDA challenged their standing to bring the suit. The two remaining plaintiffs were the Center for Food Safety and the Environmental Defense Fund.
 
“This is an important decision that protects a regulatory option that many responsible suppliers use to bring safe ingredients to the U.S. market,” Michael McGuffin, AHPA president, said.
 
The main arguments that the two plaintiff organizations made were that the GRAS process unlawfully subdelegates FDA’s statutory authority to private parties (namely those who self-affirm the GRAS status of their ingredients), that the GRAS process contradicts the regulatory intentions of the Food, Drug, and Cosmetic Acct and exceeds FDA’s statutory authority, and that the rule is “arbitrary and capricious in violation of the FDCA and the Administrative Procedures Act.”
 
In U.S. District Judge Vernon S. Broderick’s statement, and accompanying judgment, issued on September 30, he rejected each of the allegations made by the plaintiff organizations.
 
“In a final attempt to strike down the GRAS rule, Plaintiffs argue that the GRAS rule is unlawful because its criteria for determining GRAS status contradicts the FDCA. In particular, Plaintiffs aver that the criteria within the GRAS Rule differs from the FDCA’s requirement that a substance is eligible for GRAS status only if that substance is ‘generally recognized, among experts qualified by scientific training and experience… as having been adequately shown through scientific procedures… to be safe under the conditions of its intended use.’
 
“Plaintiffs cite to five reasons: the GRAS Rule fails to include sufficient criteria to ensure that the data, information, and methods upon which manufacturers base their GRAS determinations are ‘generally recognized’; the GRAS Rule does not include criteria to ensure that manufacturers’ GRAS determinations are free from conflicts of interest; the GRAS Rule does not contain any criteria to ensure manufacturers do not self-certify substances as GRAS after FDA raises safety concerns about them; FDA finalized the GRAS Rule without including any criteria to prevent manufacturers from secretly self-certifying newly synthesized or novel substances as GRAS; and the GRAS Rule fails to include criteria clarifying that the carcinogenic substances can never be deemed safe for use in food.”
 
Broderick said that the third and fourth reasons have been flagged in other challenges. He added that he disagreed with the plaintiffs’ argument that information in GRAS determination cannot be “generally recognized,” that he disagreed with the argument that there are no safeguards against potential financial conflicts of interest in the GRAS process due to the fact that certifying the notice requires a signed statement ensuring that a submission is balanced with known unfavorable information, and, lastly, that he disagreed with the fifth reason due to the fact that GRAS Rule criteria requires “reasonable certainty that the substance is not harmful under the conditions of its intended use.”
 
The plaintiff organizations will have the option of filing an appeal of the decision.