In an article published in the New England Journal of Medicine (NEJM), leading medical and food law experts have raised concerns about the U.S. Food and Drug Administration’s (FDA’s) “generally recognized as safe” (GRAS) process for the introduction of ingredients to the food supply, and are calling on the agency to take proactive steps to ensure the safety of new food substances.

The authors, Pieter A. Cohen, M.D., and Emily M. Broad Leib, J.D.—associated with the Cambridge Health Alliance, Harvard Medical School, and Harvard Law School’s Food Law and Policy Clinic—pointed to a 2022 incident of consumers experiencing liver injury due to the consumption of tara flour as an example of the dangers of the current GRAS process. Tara flour was an ingredient used in a ground beef substitute that was introduced to the food supply via the GRAS process; subsequently, FDA conducted an independent evaluation of the ingredient and concluded in 2024 that tara flour is not “generally recognized as safe,” and is therefore unapproved as a food additive.

GRAS is intended to allow widely used food ingredients, commonly understood to be safe for consumption, to remain on the market without extensive review. However, in the present day, companies have used GRAS as a way to use new additives without subjecting them to formal review.

According to the NEJM article, FDA directly reviewed the safety of GRAS ingredients prior to 1972, when independent agency evaluation was eliminated in favor of giving companies the option to voluntarily inform FDA of their own GRAS determinations. In 1997, FDA revised the voluntary process, establishing that, if a company shares its GRAS determination with the agency, FDA will either respond that it has no further questions about the substance’s safety, or that additional evidence is required. In the latter case, the company may either provide more data or withdraw its GRAS notification—while still being able to introduce the new ingredient into the food supply as a GRAS substance.

The authors stated their belief that FDA should take steps to ensure the safety of new food substances, specifically:

• Requiring that manufacturers share all new GRAS determinations with the agency
• Requiring that manufacturers base GRAS decisions on the results of multiple high-quality studies and to publicly post a summary of the evidence
• Retroactively and systematically review the safety of previously introduced GRAS substances
• Consider establishing an expert advisory committee that meets periodically to review updated safety evidence.

In light of what the authors consider FDA’s loose approach to monitoring food additive safety, state bans on some food additives have been introduced or even passed. California Assemblymember Jesse Gabriel cited the GRAS “loophole” as a reason for the California Food Safety Act, which was signed into law in October 2023 and bans the statewide sale or manufacture of foods containing four possibly toxic chemical additives.

Illinois has followed suit with its own Illinois Food Safety Act, which was introduced in April 2024 and is still pending.

“We believe [the tara flour incident] should serve as a warning that FDA’s laissez-faire approach to monitoring the safety of ingredients under its authority poses a threat to public health,” the authors concluded.