Secret GRAS rule
In this case, a federal court concluded FDA could continue to permit manufacturers to self-certify that chemical additives used in food they manufactured are safe. However, the decision acknowledged conflict-of-interest concerns about this practice, and noted that the remedy to this situation lies with Congress.
In May 2017, CSPI and other public-interest groups filed a lawsuit challenging an FDA rule that permits companies to self-certify chemical additives used in food as safe without any notice to the agency or the public.
Background on the GRAS loophole
Federal law requires the FDA to ensure that substances used in food are safe and mandates a rigorous pre-market safety review process for food additives. But, there is an exemption to that review process for substances designated as “generally recognized as safe” (GRAS).
The GRAS exemption was initially created to cover ingredients that are widely known to be safe, such as vegetable oil. And, prior to 1997, the FDA policed the exemption by requiring manufacturers to file a petition asking FDA to affirm the GRAS status of a particular use of a chemical substance.
However, FDA has allowed the GRAS loophole to swallow the law. In 1997, the FDA proposed, and in 2016 it finalized, the challenged rule that allows food and chemical manufacturers to decide for themselves, without notice to FDA or the public, that food chemicals are safe—even if the chemicals are new, not widely studied, and not widely accepted as safe.
The lawsuit alleged that the rule is unlawful and undermines the integrity of our food safety system and that it, among other things, violates the Administrative Procedure Act ("APA") because it delegates the FDA’s responsibility to monitor the safety of chemical additives to self-interested food and chemical manufacturers.
District Court Decisions
In 2018, CSPI and two other plaintiffs—Breast Cancer Prevention Partners and Environmental Working Group—were dismissed from the lawsuit on standing grounds. That is, the court determined that these plaintiffs did not allege a sufficient legal injury to bring the lawsuit. However, two other non-profit group plaintiffs—Center for Food Safety and Environmental Defense Fund—remain in the case.
In 2019, the remaining plaintiffs and the FDA filed cross motions for summary judgment. In September 2021, the District Court granted the government's motion for summary judgment. The Court concluded that the agency's secret GRAS rule was not an unlawful delegation of the FDA's food safety responsibilities and did not conflict with the Federal Food, Drug, and Cosmetic Act ("FDCA") because the FDCA is silent or ambiguous on whether manufacturers must notify the FDA of GRAS determinations and the FDA retained the authority to bring enforcement proceedings when it disagreed with manufacturers’ GRAS determinations.
While recognizing that the plaintiffs raised "legitimate concerns" about the ability of manufacturers to objectively make safety determinations about their own products, the Court also concluded that the FDA's determination was not "arbitrary and capricious" in violation of the APA because the agency provided a reasoned justification for its rule, including the need to allocate its limited resources to "higher public health priorities."