Federal health officials on Monday unveiled a proposal targeting a long-standing regulatory gap that has permitted a large number of food ingredients to reach the American market without any government notification, a development with broad implications for the packaged foods stocked in Colorado Springs stores.
The proposal takes aim at a policy stretching back decades that consumer advocates have characterized as a loophole responsible for letting thousands of unreviewed ingredients into the nation's food supply. Under the current framework, a manufacturer can make its own determination that an additive is "generally recognized as safe" — known as GRAS — with no obligation to inform or submit supporting evidence to the FDA, though some companies choose to do so voluntarily.
A study published this past March found that at least 111 substances with uncertain safety records had been introduced into foods, beverages, and supplements sold in the United States without any notification to the FDA. Altogether, roughly 10,000 additives are presently permitted in the American food supply, a category that encompasses thickeners, preservatives, and substances derived from packaging materials.
A policy shift that began in 1997 allowed manufacturers to make independent safety determinations for new additives, drawing on published science and qualified expert opinion. Over time, the roster of ingredients companies self-certified as GRAS expanded to encompass a wide range of synthetic and natural substances, none of which required outside scrutiny before entering food products. The consumer advocacy organization Center for Science in the Public Interest has described this arrangement as a "secret GRAS loophole" that "undermines the integrity of our food safety system."
Under the newly proposed rule, companies would be required to document their safety findings and submit them to regulators, giving the FDA a window to act if it identifies a potential concern. Acting FDA Commissioner Kyle Diamantas told reporters Monday that the shift closes "a decades-old information gap, giving the FDA the comprehensive visibility needed to enhance postmarket safety." Diamantas was careful to note, however, that the proposal stops short of mandating FDA review of every new ingredient, and that achieving that level of authority would require action by Congress. If the rule is finalized, the agency would have 180 days to assess each submission and could request additional data from manufacturers or ask that they hold off on introducing a new ingredient if safety concerns emerge.
Susan Mayne, an adjunct professor at the Yale School of Public Health who previously led the FDA's Center for Food Safety and Applied Nutrition under administrations of both parties, described the proposal as a step toward greater transparency. She cautioned, however, that even mandatory disclosure would not guarantee agency scrutiny of every ingredient reported, noting that notification generates a roster of substances but "does not mean that FDA has reviewed those ingredients for safety," and that consumers should not assume all disclosed ingredients have been vetted.
Legislation moving through Congress could eventually grant the FDA broader authority to require safety studies for additives already on the market, and the administration indicated it is engaged with lawmakers on legislative options tied to the GRAS process and nutrition policy, characterizing those talks as bipartisan. Food industry representatives have maintained that their internal additive reviews are equally as thorough as any the FDA would conduct.
In a separate announcement, the FDA said it had completed work on a formal definition of ultraprocessed food — the first such definition produced by the federal government — but declined to release any text or specifics, saying the definition had been forwarded to the White House for additional review. The definition is still working through a multiagency process, and people with knowledge of the internal deliberations have said the Department of Agriculture has raised concerns that it could be drawn too broadly, potentially classifying far more foods than intended. Neither announcement is expected to produce immediate changes for American consumers, though both represent priorities for Health and Human Services Secretary Robert F. Kennedy Jr., who came into office pledging to crack down on artificial colors, additives, and other food ingredients.
The FDA is accepting public comments on the GRAS notification proposal for 120 days, and the ultraprocessed food definition awaits White House and interagency clearance before any further action can be taken.