Overhauling the GRAS Loophole: Ensuring Food Safety and Transparency

In a move to address the longstanding concerns surrounding the "generally recognized as safe" (GRAS) process, U.S. Representative Rosa DeLauro (D-CT), Chair of the House Appropriations Committee, has introduced the Toxic Free Food Act to the U.S. Congress. This legislation aims to overhaul the GRAS system, which has been criticized as a "loophole" that allows food manufacturers to introduce potentially unsafe additives without adequate scientific review or public notification.

Exposing the Flaws in the GRAS System

The GRAS process was initially designed to allow widely used food ingredients, with a proven track record of safety, to remain on the market without extensive review. However, in recent years, food manufacturers have been accused of exploiting this system to introduce new additives without proper oversight.A 2010 report by the U.S. Government Accountability Office (GAO) concluded that the FDA's performance in ensuring the safety of GRAS substances was inadequate. Furthermore, a 2022 incident involving a ground beef substitute made with tara flour, a "GRAS" ingredient, led to consumer liver injuries and the subsequent rescission of its GRAS status by the FDA in 2024.Experts from Harvard Medical and Law schools have also called on the FDA to address the gaps in the GRAS process, which they believe allow potentially unsafe substances to enter the food supply. According to an estimate from Consumer Reports, approximately 1,000 GRAS substances currently exist on the market without an independent safety review or notification to the FDA.

The Toxic Free Food Act: Closing the GRAS Loophole

The Toxic Free Food Act, introduced by Rep. DeLauro, aims to overhaul the GRAS process and address these concerns. If passed, the act would prohibit manufacturers from designating any synthetic or novel chemical substance, as well as any carcinogenic substance, as GRAS.Furthermore, the act would require manufacturers to provide the FDA with detailed supporting information, including evidence about the cumulative effects of the substance, factors for adequately protective use of safety, and an application of a margin of safety to take into account the impacts of exposures for developing children and vulnerable populations.Upon receiving a GRAS notification, the FDA would be required to make the determination and supporting evidence publicly available on its website, and provide a 90-day period for the agency and the public to review each GRAS determination to ensure its safety. The act also prohibits the FDA from considering supporting evidence from experts with conflicts of interest.

State-Level Efforts to Regulate Food Additives

Concerns about the GRAS process have also inspired a wave of state-level legislation targeting food additives. In 2023, the California Food Safety Act was passed, banning several potentially toxic additives from foods sold or manufactured in the state. Assemblymember Jesse Gabriel, who spearheaded the legislation, cited the GRAS "loophole" as a key reason for writing the law.Other states are following California's lead, with bills aimed at taking additives regulation into their own hands. For example, a New York Assembly bill would require businesses to notify the State of New York when determining a substance to be GRAS and provide supporting evidence.

Federal Efforts to Improve School Lunch Safety

At the federal level, U.S. Senator Cory Booker (D-NJ) has introduced the Safe School Meals Act, which would require the FDA to systematically evaluate GRAS substances with known carcinogenic, reproductive, or developmental health harms. This bill is part of a broader effort to improve the safety of school lunches.The Toxic Free Food Act has garnered support from a coalition of organizations, including the Environmental Defense Fund, the Environmental Working Group, the Center for Science in the Public Interest, Consumer Reports, Healthy Babies Bright Future, Defend our Health, Earthjustice, the Center for Food Safety, and Breast Cancer Prevention Partners.As the debate over the GRAS process continues, the Toxic Free Food Act and other legislative efforts represent a significant step towards ensuring the safety and transparency of the food supply, and protecting the health of consumers, particularly vulnerable populations.