Recent court decision upholds the legality of the GRAS process

A recent decision by the United States District Court of the Southern District of New York upholds the legality of FDA’s GRAS (generally recognized as safe) process. In a lawsuit against the Department of Health and Human Services (HHS), and FDA, originally filed in 2017, the Center for Food Safety, Breast Cancer Prevention Partners, the Center for Science in the Public Interest, the Environmental Defense Fund, and the Environmental Working Group moved for a summary judgement on the grounds that “ the GRAS Rule (1) unlawfully subdelegates FDA’s duty to ensure food safety in violation of the United States Constitution (the “Constitution”), the Administrative Procedure Act (“APA”), and the Federal Food, Drug, and Cosmetic Act (“FDCA”); (2) exceeds FDA’s statutory authority and constitutes arbitrary and capricious agency action in violation of the FDCA [Federal Food, Drug, and Cosmetic Act] and APA; and (3) conflicts with the FDCA.”

The defendants, Xavier Becerra, secretary of HHS, and Janet Woodcock, acting commissioner of FDA, made a cross-motion for summary judgment arguing that “the GRAS Rule is a lawful exercise of FDA’s authority under the FDCA, and is not unconstitutional.”

One of the main criticisms of the GRAS rule is that independent conclusions of GRAS lack transparency and are inherently a conflict of interest. Prior to the GRAS final rule, FDA instituted a voluntary GRAS affirmation process in which manufacturers would ask the agency to affirm an ingredient’s GRAS status. This was a resource-intensive process. In 1997, FDA replaced this process with a notification procedure, whereby FDA could be notified of a conclusion that a particular use of a substance was GRAS. In 2010, the Government Accountability Office (GAO) published a report that urged FDA to “(1) strengthen its oversight over GRAS substances by finalizing the 1997 proposed rule; (2) minimize conflicts of interest in GRAS assessments performed by third parties; and (3) require any company that conducts a GRAS determination to provide FDA with basic information about this determination, such as the substance's identity and intended uses.”

In 2016, the final GRAS rule codified the voluntary notification process mentioned previously. Consequently, the initial action filed by the plaintiffs on May 22, 2017, sought 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.”

Ultimately, U.S. District Judge Vernon S. Broderick agreed with the defendants and denied the plaintiffs’ motion, upholding the current GRAS framework. In his opinion, Broderick acknowledges some of the plaintiffs’ concerns but writes that FDA’s GRAS rule does not conflict with the FDCA, and represents a reasonable interpretation of the law. “Certain portions of the Record cited by Plaintiffs raise an issue inherent in this case—the increase in processed foods and food additives…I am cognizant of this reality, and of the fact that circumstances have changed since the enactment of the Food Additives Amendment. Still, as was recognized by both FDA and GAO, it remains unclear under the statute whether FDA even has the authority to make GRAS notifications mandatory. I decline Plaintiffs’ invitation to rewrite the statute. The remedy Plaintiffs seek lies with Congress, not me, and Congress has chosen not to act despite the increase in the number of food additives over the last five decades.”

While there was a recent bill (HR. 3699) introduced to the House that would significantly alter the GRAS process, it is unlikely to receive the necessary support to pass. The plaintiffs will likely appeal the decision, but FDA will then appeal that decision, dragging the legal process out even more.

“The court delivered a powerful message by reinforcing the legality of the self-affirmed GRAS process,” said Ashish Talati, partner at Amin Talati and Wasserman, to Nutritional Outlook. “The court’s ruling will be useful to companies that have invested substantial resources to establish the safety of their ingredients through self-affirmation of GRAS.”

Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD) echoed this sentiment. “This is an important decision that protects a regulatory option that many responsible suppliers use to bring safe ingredients to the U.S. market,” he said.