RFK Jr takes aim at ‘unvetted’ ingredients in US food supply with new FDA proposal

RFK Jr takes aim at ‘unvetted’ ingredients in US food supply with new FDA proposal Neither of Monday's announcements are likely to immediately impact American diets, which are blamed for a host of chronic diseases such as obesity, diabetes and heart disease - Bookmark U.S. health officials have proposed a rule change that would require food producers to inform authorities prior to introducing new ingredients or additives into packaged and processed goods. This measure seeks to alter a long-standing policy criticized by advocates as a regulatory loophole that has permitted thousands of unvetted substances to enter the nation's food supply. Under the Food and Drug Administration's draft regulation, businesses would be required to document and present written safety justifications for new ingredients, allowing officials to examine potential hazards. Currently, manufacturers independently determine whether an ingredient qualifies as "generally recognized as safe," or GRAS, without any obligation to report or submit evidence to the agency, though a subset of companies does so voluntarily. "Shifting to a mandatory notification system closes a decades-old information gap, giving the FDA the comprehensive visibility needed to enhance postmarket safety," acting FDA Commissioner Kyle Diamantas told reporters on Monday. A 120-day public comment window has been opened by the agency to gather feedback on the plan. Susan Mayne, former director of FDA's food program, observed that while the rule would provide the agency with improved oversight of the wide array of market additives, only a minor fraction would face formal evaluation. "This is a reasonable first step towards a more complete inventory, but most self-affirmed GRAS ingredients will still not be reviewed for safety by the FDA, with food ingredient safety continuing to be risk-based," said Mayne, who is now a public health expert at Yale University. Additionally, the FDA intends to make public a directory of submissions provided by manufacturers. Mayne emphasized that consumers must recognize that "inclusion on the list would not mean FDA thinks the ingredient is safe." Scrutiny of ultraprocessed food continues, but with few details In a related step, the agency announced it has finalized the federal government's initial formal definition for ultraprocessed foods, though specific wording and details remain undisclosed. The draft definition has been forwarded to the White House for further evaluation. Public health proponents view a standardized definition as a critical milestone toward examining products linked to widespread chronic illnesses in the population. A formal baseline could facilitate expanded federal research and lay the groundwork for potential future restrictions or mandatory warning labels. Neither measure is anticipated to instantly alter consumer eating habits, which remain heavy in sugar, sodium, and fats that contribute to conditions including heart disease, diabetes, and obesity. Nevertheless, these efforts align with the central agenda of Health Secretary Robert F. Kennedy Jr., who assumed office with a pledge to target synthetic dyes, additives, and related compounds. "These two actions will change how the federal government oversees what’s in our food and how we understand the foods that Americans eat," Kennedy said at an event Monday at HHS headquarters. Ultraprocessed items undergo industrial manufacturing processes involving additives, colorings, preservatives, and other elements absent from home cooking. Common examples comprise soft drinks, sweetened breakfast cereals, snack chips, frozen pizzas, and processed grocery goods. Researchers have spent more than ten years trying to establish standardized classifications for processed foods. However, broad criteria present challenges, as they may capture items such as whole wheat bread, granola, and yogurt—foods that undergo substantial processing yet maintain nutritional value. Recent classification frameworks have incorporated specific exemptions for items fulfilling established dietary standards regardless of their processing level. FDA proposal would bring new insights on additives used by food companies Approximately 10,000 chemical additives, including thickeners, preservatives, and packaging substances, are currently permitted across the domestic food supply. Advocacy groups have maintained for years that many of these compounds lack rigorous safety evaluations due to the FDA practice allowing companies to self-certify additives under the "generally recognized as safe," or GRAS, designation. Diamantas clarified on Monday that the proposed adjustments would not force every new ingredient to undergo a full agency evaluation, noting that mandatory pre-market approvals would require legislative action from Congress. "What we’re doing is requiring companies that utilize the pathway to notify us of their conclusions so that we have greater visibility," Diamantas said. Framework guidelines specify a 180-day window for the agency to review filings. Should health officials identify potential safety issues, they could seek supplementary data or request that the manufacturer postpone launching the ingredient. Reform advocates argue that mere notification does not go far enough. "It must also include strong, science-based safety standards and thorough, independent FDA review before chemicals are allowed in our food," said Melanie Benesh of the nonprofit Environmental Working Group. Kennedy indicated that the Trump administration intends to petition Congress to grant the FDA expanded authority over food additives. "Congress needs to give FDA the additional tools it needs to keep pace with the changing food supply and protect the American people," Kennedy said. A rule change in the 1990s created what advocates call a loophole In principle, any intentional food additive requires formal agency authorization unless deemed inherently safe. Since the late 1950s, federal oversight has acknowledged that staple items like vinegar and spices are widely consumed and traditionally regarded as harmless. Although the agency originally evaluated GRAS exemptions directly, the process proved resource-intensive. Beginning in 1997, the FDA authorized food producers to independently decide whether a new substance was safe based on published research and expert consensus. Over time, the inventory of self-certified GRAS substances expanded to encompass numerous natural and synthetic additives, which entered commercial distribution without external government evaluation. Health advocacy organizations, including the Center for Science in the Public Interest, contend this framework created a "secret GRAS loophole." Industry representatives maintain that corporate safety evaluations are every bit as comprehensive as formal regulatory reviews.