A recently introduced bill would significantly alter the GRAS process if passed


House Appropriations Committee Chair Rosa DeLauro (D-CT-03) recently introduced new legislation that would significantly alter the GRAS (generally recognized as safe) process. In the new legislation, called the Toxic Free Food Act, manufacturers will be required to notify the Secretary of Health and Human Services of their GRAS determinations, and each determination will be made publicly available on the FDA website. The Secretary and the public will then have a period of at least 90 days to review each determination and object to them, if necessary. Additionally, synthesized, and novel substances would be prohibited from being GRAS, and the new bill will create a process by which the Secretary can reassess any substance that has been determined to be GRAS, if the determination did not meet the revised standards set forth in the bill.

Under the current GRAS process, manufacturers independently perform safety reviews to determine that the substance is reasonably certain not to be harmful under the conditions of its intended use, based on common scientific knowledge, but may choose whether or not to inform FDA of this determination. As such, consumer advocates have criticized the regulation as lacking transparency and effectiveness, as well as being unethical. The Center for Food Safety (CFS; Washington, D.C.), for example, has endorsed the new legislation for these reasons.

“For years, FDA has allowed food and chemical companies to decide whether long-lasting toxic chemicals, such as PFAS or orthophthalates, are safe to eat. The Toxic Free Food Act will make FDA take charge of food safety instead of the industry,” said Jaydee Hanson, policy director at CFS, in a press release. CFS, along with the Center for Food Safety, Breast Cancer Prevention Partners, Center for Science in the Public Interest, Environmental Working Group, and Environmental Defense Fund sued the Department of Health and Human Services and FDA to challenge the GRAS final rule in 2017. The legislation remains under review in federal court.

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Nutritional Outlook, 11 June 2021
; https://www.nutritionaloutlook.com/view/a-recently-introduced-bill-would-significantly-alter-the-gras-process-if-passed