U.S. health officials on Monday proposed a rule change requiring food manufacturers to notify regulators before introducing new ingredients or additives into processed or packaged foods. The proposal would overhaul a decades-old policy that public health advocates have labeled a regulatory loophole, blaming it for allowing thousands of unvetted ingredients to enter the U.S. food supply.

Under the proposed rule from the Food and Drug Administration, companies would be required to document and submit their safety rationale for new ingredients, giving regulators the opportunity to investigate potential risks. Currently, companies can independently decide whether an ingredient or additive is "generally recognized as safe," or GRAS, with no obligation to notify or submit evidence to the FDA — although some firms do 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. The FDA will accept public comments on the proposal for 120 days.

Susan Mayne, former director of the FDA's food program and now a public health expert at Yale University, said the new requirement would give the agency a clearer picture of the vast number of ingredients on the U.S. market, though only a small fraction would actually undergo review.

"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," Mayne said.

The FDA also plans to publish a list of company-submitted ingredients. Mayne cautioned that Americans should understand that "inclusion on the list would not mean FDA thinks the ingredient is safe."

Diamantas stressed that the new policy would not require all new ingredients to undergo FDA review, noting that mandatory reviews would need to be enacted by Congress. "What we're doing is requiring companies that utilize the pathway to notify us of their conclusions so that we have greater visibility," he said.

Under the proposal, the FDA would be expected to review new ingredient submissions within 180 days. If regulators identified safety concerns, they could request additional information or ask the company to delay introducing the ingredient.

Consumer advocates who have long pushed for changes said the FDA's proposal should go beyond simply requiring advance notice. "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.

In a separate move, the FDA announced it has completed work on the federal government's first-ever definition of ultraprocessed food but did not release details or proposed language. The agency said it submitted the definition to the White House for further review.

Health advocates consider an official definition of ultraprocessed food a critical step toward bringing greater scrutiny to meals blamed for multiple chronic health problems afflicting Americans. A government-backed definition could pave the way for more federal research and, eventually, possible warning labels or other restrictions.

Ultraprocessed foods are made using industrial processing and additives — including colors, preservatives, or other ingredients not found in home kitchens. These foods include sugary cereals, sodas, chips, frozen pizzas, and other grocery items. Scientists have been working to define and classify processed foods for well over a decade, with the NOVA classification system developed by Brazilian researchers becoming the most widely used framework in scientific literature. Sweeping definitions come with downsides, however. They can be applied to foods like whole grain bread, yogurt, and granola that are all highly processed yet still considered nutritious. Some recent efforts to define ultraprocessed foods include carve-outs for products that meet nutrition standards despite having processed ingredients.

Neither of Monday's announcements is likely to immediately impact American diets, which are packed with fats, sodium, and sugar and blamed for a host of chronic diseases such as obesity, diabetes, and heart disease. However, both initiatives are top priorities for Health Secretary Robert F. Kennedy Jr., who entered government vowing to crack down on artificial colors, additives, and other ingredients as part of his "Make America Healthy Again" agenda.

"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.

Kennedy said the Trump administration would ask Congress to grant the FDA additional powers over ingredients. "Congress needs to give FDA the additional tools it needs to keep pace with the changing food supply and protect the American people," he said.

In the U.S., an estimated 10,000 additives are permitted in food, including thickeners, preservatives, and packaging ingredients. Consumer advocates have long argued that many of those ingredients have never been properly vetted because of the FDA's policy allowing manufacturers to self-certify additives as GRAS. By contrast, the European Union requires pre-market safety assessment and authorization for food additives through the European Food Safety Authority before they can be used.

Any substance intentionally added to food is supposed to undergo formal review unless the additive is considered safe. Since the late 1950s, the government recognized that many common ingredients in foods — such as spices and vinegar — were widely consumed and understood to be safe. The FDA policed the GRAS exemption for years, but the process required significant time and resources. Starting in 1997, the FDA began allowing companies to independently determine that a new additive is safe based on publicly available scientific evidence and the consensus of qualified experts.

However, the list of products deemed GRAS by companies grew to include many synthetic and natural additives, all incorporated into the food supply without independent review. The process has created a "secret GRAS loophole," according to the Center for Science in the Public Interest and other health groups. Food industry officials contend their internal reviews of additives are as rigorous as the FDA's own process.

This story was originally featured on Fortune.com (https://fortune.com/2026/08/11/fda-food-additive-list-self-certified-unchecked/).