U.S. health officials have proposed a rule change that would require food manufacturers to notify the Food and Drug Administration (FDA) before introducing new ingredients or additives into processed or packaged foods. The move aims to close what advocates have called a regulatory loophole that has allowed thousands of unvetted ingredients into the U.S. food supply.
Under the proposed rule, companies would be required to document and submit their safety findings for new ingredients. This would give regulators the opportunity to investigate potential safety risks. Currently, manufacturers can determine for themselves if an ingredient is “generally recognized as safe” (GRAS) without a mandatory requirement to notify or submit evidence to the FDA, though some voluntarily do.
Acting FDA Commissioner Kyle Diamantas stated that the proposed shift to a mandatory notification system would close a decades-old information gap, providing the FDA with the comprehensive visibility needed to enhance postmarket safety. The FDA will accept public comments on the proposal for 120 days.
In a separate but related initiative, the FDA announced it has completed its work on the federal government's first-ever definition of ultraprocessed food. The agency has submitted the definition to the White House for review.
Health advocates consider an official definition of ultraprocessed food a critical step toward increasing scrutiny of packaged foods, which are linked to numerous chronic health problems. A government-backed definition could potentially lead to more federal research, and eventually, labeling or restrictions on such foods.
Ultraprocessed foods are typically made using industrial processes and include ingredients not commonly found in home kitchens, such as additives, colors, and preservatives. Examples include sugary cereals, sodas, chips, and frozen pizzas. Scientists have been working to define and classify processed foods for over a decade, but broad definitions can sometimes encompass nutritious foods that undergo significant processing, like whole grain bread and yogurt.
An estimated 10,000 additives are currently allowed in U.S. foods, including thickeners, preservatives, and packaging ingredients. Consumer advocates have long argued that many of these ingredients have not been thoroughly vetted due to the FDA's policy allowing companies to self-certify new additives as GRAS. This process has been described by the consumer advocacy group Center for Science in the Public Interest as a "secret GRAS loophole" that undermines food safety.
FDA's Diamantas clarified that the new policy would not mandate FDA review for all new ingredients, noting that such a requirement would necessitate an act of Congress to alter the FDA's authority. The current proposal aims to ensure companies notify the FDA of their safety conclusions regarding new ingredients, thereby increasing transparency for both the agency and consumers.
Under the proposal, the FDA would have 180 days to review new ingredient submissions. If safety concerns arise, regulators could request additional information from manufacturers or ask them to delay the ingredient's introduction. Substances intentionally added to food are subject to formal review unless deemed safe. Since the late 1950s, many common ingredients like spices and vinegar have been recognized as safe due to widespread consumption. The FDA historically policed the GRAS exemption, but starting in 1997, it allowed companies to independently determine GRAS status based on available scientific evidence and expert consensus, leading to a significant increase in self-certified additives entering the food supply without independent FDA review.