The Trump administration's FDA proposed a rule requiring food manufacturers to notify the agency before slipping new additives into the food supply, ending a self-certification system that let companies decide on their own what was safe to eat.
Acting FDA Commissioner Kyle Diamantas announced the proposed rule on Monday, calling it a fix for a gap in federal food oversight that has been widening since the late 1950s. Under current practice, companies can declare a new chemical additive "generally recognized as safe", known by the acronym GRAS, and start using it in packaged food without ever telling the FDA. That voluntary system expanded in 1997, and an estimated 10,000 additives now sit in the American food supply, many of which have never faced independent federal review.
The proposed rule would change that. Food manufacturers would have to document their safety findings for any new ingredient and submit them to the FDA before putting it on store shelves. The agency would then have 180 days to review the submission. If regulators flag concerns, they could demand more data or ask the company to hold off on introducing the ingredient.
Diamantas framed the shift as overdue, telling reporters:
"Shifting to a mandatory notification system closes a decades-old information gap, giving the FDA the comprehensive visibility needed to enhance postmarket safety."
He stressed that the proposal does not require every new ingredient to undergo full FDA review before it reaches consumers. That kind of mandatory premarket approval, he said, would require Congress to rewrite the FDA's food authorities entirely.
Health Secretary Robert F. Kennedy Jr. spoke at HHS headquarters on Monday alongside the FDA announcement. He has made food-additive reform a signature issue since entering government, vowing to crack down on artificial colors, preservatives, and other chemicals in processed food. Kennedy cast the twin announcements, the notification rule and a separate move on ultraprocessed food, as a turning point.
"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 also said the Trump administration would ask Congress to grant the FDA additional powers over food ingredients, though he did not spell out what those powers would look like. Just The News reported that Kennedy tied the effort to the broader chronic-disease crisis, stating, "We cannot reverse America's chronic disease epidemic without transforming our food system." Nearly 60 percent of the American diet consists of ultraprocessed foods, and childhood obesity now affects more than one in five American children.
The administration's push on food additives is not new. Earlier this year, Kennedy and then-FDA Commissioner Dr. Marty Makary announced a nationwide phase-out of eight synthetic food dyes found in cereals, sweets, sports drinks, and yogurt. Kennedy said at the time that those compounds "offer no nutritional benefit and pose real, measurable dangers to our children's health and development." Manufacturers were directed to eliminate the dyes by next year.
The roots of the problem go back decades. In the late 1950s, the federal government recognized that many common food ingredients, spices, vinegar, everyday staples, were so widely consumed and well understood that they did not need formal approval. That exemption made sense for salt and pepper. It made less sense as the food industry grew more complex.
By 1997, the FDA had formalized a system allowing companies to independently determine that a new additive was safe, based on publicly available scientific evidence and expert consensus. The company did not have to tell the FDA. It did not have to submit its findings. It simply made the call and moved on.
Consumer advocacy groups have long called this arrangement a backdoor that undermines public confidence. The Center for Science in the Public Interest has described it as a "secret GRAS loophole" that "undermines the integrity of our food safety system." The Washington Examiner characterized the proposed rule as a major policy win for the Make America Healthy Again movement, noting that the changes replace a voluntary compliance system that has existed since the 1950s.
Unnamed food industry officials pushed back, contending that their internal reviews of additives are as rigorous as the FDA's own processes. But that argument has always had a structural weakness: if the reviews are genuinely rigorous, there is no reason to keep them from regulators.
Alongside the notification rule, the FDA announced it had completed the federal government's first-ever definition of ultraprocessed food. Scientists have spent well over a decade working to classify processed foods, and the FDA said it submitted the completed definition to the White House for further review.
The agency did not release any details or proposed language. That means the public does not yet know which foods or ingredients fall inside the definition, or what regulatory consequences, if any, would follow. AP News reported that advocates say a formal definition could pave the way for federal research, warning labels, or restrictions on ultraprocessed products.
Neither announcement is expected to immediately change what Americans find on grocery shelves. The notification rule faces a 120-day public comment period before it can move forward. The ultraprocessed food definition must clear White House review. And the broader powers Kennedy wants, mandatory premarket approval of new ingredients, would require an act of Congress.
Even groups that support the direction of the rule want more. Melanie Benesh of the Environmental Working Group said the 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."
That concern points to a real limitation of the proposed rule. Mandatory notification gives the FDA visibility it did not have before. But visibility is not the same as authority. Under the proposal, the FDA can request more information or ask a company to delay an ingredient's introduction. It cannot block the ingredient outright, not without the congressional action both Diamantas and Kennedy acknowledged is necessary.
Breitbart noted that the moves align with Kennedy's stated priorities but are unlikely to immediately change American diets, a point the administration itself has not disputed.
Still, the gap between the current system and the proposed one is not trivial. Right now, a food company can add a new chemical to a product and never tell the FDA it did so. Under the new rule, the company would have to show its work. The FDA would have six months to look at it. And the public would at least know the process happened.
For decades, the federal government let the food industry grade its own homework. Requiring companies to turn in the paper is a modest step, but it is the first one, and it was long overdue.
