FDA seeks to close decadeslong loophole for food additives

(CNN) — The US Food and Drug Administration released a long-awaited plan to close a loophole in food regulation that lets manufacturers put certain chemicals in products without notifying national food regulators.

The FDA is proposing that food manufacturers notify the agency when they use ingredients that are generally recognized as safe, or GRAS, in their products. It’s a step toward healthier food reforms long advocated by the “Make America Healthy Again” movement, but a step behind more aggressive proposals that would require manufacturers to prove that refined sugars and flours are safe through new studies.

Still, MAHA leaders including US Health and Human Services Secretary Robert F. Kennedy Jr. applauded the proposed rule Monday as a major win in the administration’s efforts to crack down on ultraprocessed foods and promote healthier diets.

“We don’t even know exactly how many chemicals are in the food that Americans eat every day,” Kennedy said Monday at the HHS building, flanked by colorful posters touting the reverse food pyramid, urging people to “eat real food” and depicting the artificial food dye Red 40 as a cartoon monster.

The rule is still only a proposal, and will be subject to industry and public comment over the months to come.

But the plan “lays a blueprint designed to work effectively for FDA oversight, responsible industry, and consumer safety advocates alike,” acting FDA Commissioner Kyle Diamantas told reporters Monday morning.

Another much-anticipated MAHA plan, a definition of ultraprocessed foods, is still working through review with multiple federal agencies including the US Departure of Agriculture. There have been concerns, primarily from the USDA, that the definition could be overly broad and inadvertently classify too many foods as ultraprocessed, according to three people familiar with internal discussions.

Vani Hari, a longtime MAHA advocate and blogger under the name “Food Babe,” told reporters she is familiar with that concern and that it is arising from food manufacturers. Hari, who spoke at the HHS event, said she would like the federal government to take up the definition adopted by California last year that defines an ultraprocessed food as one containing nonnutritive sweeteners; high amounts of saturated fat, sodium and added sugar; and other additives such as artificial food dyes.

With the definition still under review, the GRAS rule proposed Monday is seen as a crowning achievement of Kennedy’s food agenda.

“Industry hijacked the loophole and drove a convoy of chemical trucks through it, straight into the American food supply,” Kennedy said Monday. “The FDA was left with a major blindspot.”

Program would be mandatory

At least 111 substances of unknown safety have been added to foods, drinks and supplements sold in the United States without alerting the US Food and Drug Administration, according to a study released this March.

Companies typically need to demonstrate that a new food ingredient is safe by providing widely accepted scientific evidence. However, notifying the FDA of the data is voluntary, meaning food manufacturers can self-determine that their ingredients are safe.

The proposed rule announced Monday would require manufacturers to notify FDA, shifting GRAS standard from a voluntary program to a mandatory system, Diamantis said.

In a statement Monday, Americans for Ingredient Transparency — a coalition that includes the Consumer Brands Association, which represents most major food companies — pushed for action by Congress.

“AFIT supports meaningful, science-based modernization of the GRAS program and efforts to strengthen consumer confidence in the safety and transparency of our food supply. The most durable way to achieve those goals is through bipartisan Congressional action that establishes a transparent, nationally uniform framework for food ingredient oversight,” AFIT Senior Adviser Patrice Onwuk said, adding that Congress needs to make sure FDA has the sources to implement GRAS reform.

Legislation underway in Congress would grant FDA more authority to require studies for certain food additives to stay on the market.

Diamantis said the administration is working with Congress “on legislative options to further address the GRAS process and nutrition reform,” and noted those talks have been bipartisan.

Asked by reporters if she was disappointed that Monday’s rule did not go further — requiring manufacturers to retroactively prove ingredients’ safety, Hari said the current proposal is an important first step.

“I think what’s really important about the GRAS rule is that it provides transparency into what the food industry is putting into our food for the first time,” Hari said.

‘A good step … but it’s so obvious’

“This is a good step. Food advocates have been calling for this for decades, and it’s good that they’re doing it. But it’s so obvious,” said Dr. Marion Nestle, the Paulette Goddard Professor Emerita of Nutrition, Food Studies and Public Health at New York University.

What isn’t obvious is how or when consumers will see changes to the food supply, she added. Since the proposed rule impacts notification — but not the industry’s ability to self-determine GRAS status — there are still questions that aren’t answered. Those include if the FDA will have the staffing required to review the science critically, what enforcement will look like, and what will happen if the FDA does not deem an ingredient as safe, Nestle said.

“They have closed the GRAS loophole. They haven’t solved the food additive problems by any means,” Nestle said. “They have so much opportunity to make really important changes in the food system, and I’m just not seeing them.”

Melanie Benesh, vice president for government affairs at the Environmental Working Group, said “true GRAS reform requires more than mandatory notification.

“It must also include strong, science-based safety standards and thorough, independent FDA review before chemicals are allowed in our food. And it must address the thousands of substances already on the market that have not been meaningfully reviewed in decades.”

Nearly 55% of adults and 62% of children in the United States get their daily calories from ultraprocessed foods, according to the US Centers for Disease Control and Prevention. That’s not surprising, experts say, considering that about 70% of the products on grocery store shelves are UPFs.

Four out of five, or 80% of foods marketed to children between 6 months and 36 months are ultraprocessed, according to a study published in July. Nearly half of those items also failed to meet at least one nutritional benchmark for children set by the World Health Organization.

In his confirmation hearings and numerous other appearances, Kennedy has blamed dramatic spikes in obesity and chronic conditions among Americans on the “poison” in ultraprocessed foods, or UPFs.

In May 2025, Kennedy and his Make American Healthy Again Commission promised that official guidance on UPFs would arrive quickly. The final report released in September — which was supposed to announce specific policy actions — instead called for the government to “continue efforts to develop a U.S. government-wide definition.”