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

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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.

“American families deserve to trust that the food in our stores and supermarkets is safe,” said DeLauro, in a press release. “The current notification system for ‘generally recognized as safe’ erodes the public’s trust in food safety. The food industry is designating new ingredients as GRAS to take advantage of this loophole so they can rush new chemicals to market with no oversight. Those that choose to notify FDA of their new substance get to supply their own, company-funded science and keep it away from the eyes of the public. This approval process must be mandatory, transparent, and independent in order to maintain the trust of American consumers. We need to close the GRAS loophole.”

While critics claim the GRAS process is dangerous to consumers, industry members and regulators largely believe the process works well, according to John Endres is chief science officer at AIBMR Life Sciences Inc. (Seattle, WA), a scientific and regulatory consulting and compliance firm specializing in GRAS and NDI work. “For the most part, industry and regulators find the GRAS process quite credible,” he recently told Nutritional Outlook editor-in-chief Jennifer Grebow, adding, “The program is working very well in my opinion.”

As evidence, Endres points out that there are few adverse events that relate to substances in food, compared to adverse events reports from taking pharmaceuticals, for example. Though he did express openness to greater transparency in the GRAS process. “I think a system could easily be developed to have somewhat greater transparency to weed out the rare or inadvertent ‘bad player,’” he stated. “A requirement to be listed on a GRAS Independent Conclusion database”—like the one AIBMR itself maintains on its own website as a public service—“managed by FDA would be a good start. This could include information such as: company, ingredient, simple manufacturing description, intended uses, resulting exposure, and a few bullet points about why this is safe for chronic consumption every day for the rest of your life (such as the NOAEL from the pivotal 90-day toxicology study).”

Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, D.C.) agrees that there is a lack of transparency in the GRAS process, but that the proposed legislation is overly burdensome. "Where the bill goes too far is dictating exactly how the GRAS determination is conducted and allowing the FDA and the public to object," Mister explains. "At that point, the legislation has moved beyond transparency of the process to pre-market approval for the GRAS ingredient, which is not what was intended by the GRAS self-declaration.”

Of course, with the current state of Congress, whether or not the bill will have any traction is another story. "“We are not aware of any strong support for this legislation in the current Congress," says Mister. "Given the divisive partisan gridlock and the wealth of other issues before this Congress, we think it is unlikely the bill will get substantial consideration in this term.”

This article was updated to include commentary from CRN on June 16, 2021 at 11:55AM