A federal judge in New York on Sept. 30 dismissed a lawsuit claiming the FDA's "Generally Recognize As Safe" (GRAS) process is flawed because it "unlawfully sub-delegates FDA’s regulatory duties to private industry."
In 2017, the Center for Food Safety and the Environmental Defense Fund filed the suit in the Southern District of New York seeking to overturn the GRAS rule. In addition to questioning the delegation of this ingredient safety certification, the suit claimed the FDA violated the Administrative Procedures Act by exceeding the agency's statutory authority, and the rule’s criteria for determining GRAS status conflicts with the Federal Food, Drug, & Cosmetic Act.
The court rejected all three arguments.
While food additives are subject to review and (essentially) approval by FDA, the agency in 1997 created a process by which companies could submit a notice stating their ingredients are safe for specific uses. Such a claim must be made with substantial scientific evidence by independent experts or it's rejected by the agency.
Essentially, it puts the burden for determining an additive's safety on the petitioner, not the agency.
The FDA reviews the petition and, if it agrees with the findings, sends a letter to the company that it has no questions or objections to the company’s GRAS claim, and that ingredient can be used in food. If it objects, the ingredient cannot be used. The agency refined the rule in 2016 in response to a lawsuit.
"We are extremely disappointed by the court's ruling that will continue to allow FDA to flout its regulatory duties and outsource the job to self-interested food corporations driven by their bottom line rather than the public interest," said George Kimbrell, legal director for Center for Food Safety. "We are carefully reviewing the decision and considering all legal options, including appeal."
"This outcome is welcome news for industry, as FDA’s voluntary GRAS Notice process provides industry with the flexibility necessary to promote innovation in the food sector," said lawyers at law firm Covington & Burling LLP.