DeLauro's Toxic Free Food Act Targets GRAS Additive Rules

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Rep. DeLauro Introduces Toxic Free Food Act

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Tuesday, October 8, 2024

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Representative Rosa DeLauro has introduced the Toxic Free Food Act to require FDA to “close the ‘Generally Recognized as Safe’ (GRAS) loophole and make chemical food additives subject to FDA approval and oversight.”
According to DeLauro, the GRAS loophole permits companies to determine whether food additives are safe without oversight from FDA through the voluntary GRAS notification system. This allows “potentially dangerous chemicals” to be present in the food supply.
The Toxic Free Food Act would require FDA to amend its regulations to prohibit manufacturers from marketing a substance as GRAS without providing notice to FDA, making the GRAS notification system mandatory. Public comment would be required for all GRAS notifications. In addition, newly synthesized or novel chemical substances and carcinogenic substances would not be permitted to be GRAS.
Other provisions of the Act would require revisions to FDA’s regulations to:
- Prohibit reliance on the determination of experts with conflicts of interest when determining whether a substance is GRAS;
- Incorporate recommendations into the November 2017 draft guidance “Best Practices for Convening a GRAS Panel;”
- Create a process to systematically reassess any substance that was previously determined to be GRAS if the determination did not meet the revised standards.
Finally, FDA would be required to reestablish the Food Advisory Committee to work on the reassessment standards, process, and methods necessary to complete the reassessment of previous GRAS substances.
DeLauro has also submitted written comments to FDA urging the agency to close the GRAS loophole, stating that “this loophole and FDA inaction have failed to keep us safe from chemicals added to our food . . . To rebuild consumer confidence, the FDA must take bold action to ban or restrict food chemicals of concern and to reassert its regulatory role and close the loopholes that allow the chemical companies to decide which chemicals are safe for consumers voluntarily.”
Given the current political climate, the prospects for this bill are not clear. As most readers likely know, the option to develop a GRAS position for a food ingredient was added to the Federal Food, Drug, and Cosmetic Act in 1958. Although the GRAS system has been criticized by various consumer groups in recent years, responsible companies have used it successfully to bring new, safe food ingredients to the market.