FDA Proposes Closing Decades-Old Food Additive Loophole

U.S. health officials on Monday proposed a rule change that would require food manufacturers to notify regulators before introducing new ingredients or additives into processed or packaged foods, a move that could fundamentally reshape how the Food and Drug Administration oversees the nation’s food supply.

The proposal, announced by acting FDA Commissioner Kyle Diamantas, would close a decades-old regulatory gap that consumer advocates have long criticized as a loophole allowing thousands of unvetted ingredients into American food. Under the current system, companies can decide for themselves whether an ingredient or additive is “generally recognized as safe” (GRAS), with no requirement to notify or submit evidence to the FDA.

“Shifting to a mandatory notification system closes a decades-old information gap, giving the FDA the comprehensive visibility needed to enhance postmarket safety,” Diamantas told reporters Monday, according to AP News.

The GRAS Loophole Explained

The GRAS framework dates to the 1958 Food Additives Amendment, which requires premarket approval of anything intentionally added to food unless the substance is generally recognized as safe. The exemption was originally intended for ingredients with long histories of safe use, such as vinegar, salt, and spices.

But 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. This created the “self-affirmed GRAS” pathway, where a company can convene its own panel of experts, conclude an ingredient meets the safety standard, and market it without notifying the agency. There is no requirement to submit anything and no public database of self-affirmed ingredients.

An estimated 10,000 additives are currently allowed in food in the U.S., including thickeners, preservatives, and packaging ingredients. At least 111 food additives entered the U.S. food supply through the self-affirmed GRAS pathway, according to an Environmental Working Group analysis from March 2026.

The process has created a “secret GRAS loophole” that “undermines the integrity of our food safety system,” according to the consumer advocacy group Center for Science in the Public Interest.

What the Proposal Would Do

Under the proposed rule, companies would have to document and submit their safety findings for new ingredients, giving regulators the opportunity to investigate if they see a potential safety risk. The proposal would apply to all ingredients currently on the market using the GRAS framework, in addition to new ingredients coming out. Companies with GRAS substances already on the market would need to let the FDA know how the additive is used, with information made public in a database.

The FDA would complete an initial review of new ingredient notices within 45 days and a substantive review within 180 days. If regulators have safety concerns, they could request additional information from manufacturers or request that they delay introducing the ingredient.

“What we’re doing is requiring companies that utilize the pathway to notify us of their conclusions so that we have greater visibility into those conclusions and consumers have awareness,” Diamantas said.

The FDA will take comments on the proposal for 120 days.

Ultraprocessed Food Definition

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

Health advocates consider an official definition of ultraprocessed food a key step toward bringing greater scrutiny to packaged foods blamed for multiple chronic health problems afflicting Americans. Ultraprocessed foods — made using industrial processing and additives, colors, preservatives, or other ingredients not found in home kitchens — make up approximately 55% of Americans’ calories, rising to 67% among children.

A government-backed definition could pave the way for more federal research and, eventually, possible labeling or other restrictions on processed foods. However, as The Guardian noted, sweeping definitions come with downsides — they can apply to foods like whole grain bread, yogurt, and granola that are highly processed but still considered nutritious.

Kennedy’s MAHA Agenda

Both initiatives are considered top priorities for Health Secretary Robert F. Kennedy Jr., who has made food policy reform a cornerstone of his Make America Healthy Again agenda. Kennedy directed the FDA to begin rulemaking to eliminate the self-affirmed GRAS pathway in March 2025.

“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 also said the Trump administration would ask Congress to grant FDA additional powers over food 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.

Expert Reactions

Consumer advocates have welcomed the proposal as a step forward but say it doesn’t 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.

Marion Nestle, professor emerita of nutrition, food studies, and public health at New York University, was more skeptical. “You have to be kidding. That’s all?” she asked, questioning what took so long for “something so simple and obvious” as closing the loophole. Nestle noted that even with mandatory notification, “the company is still responsible for the science and will still be hiring its own experts to say the additive is safe.”

Diamantas stressed that the new policy would not require all new ingredients to undergo FDA review — that type of mandatory review would need to be enacted by Congress to rewrite FDA’s food authorities.

Industry Impact and Legal Questions

The food industry faces significant compliance costs under the proposal. An unpublished version of the regulation estimates the rule will cost $10.5 million per year on average, with the bulk of compliance costs falling on companies.

“This is a huge deal for the food industry,” said Amaru Sanchez, a food and agriculture lawyer at Akin Gump Strauss Hauer & Feld, according to STAT News. He noted it would have ripple effects throughout the food system.

The rule also faces legal questions. In the preamble to its 2016 GRAS final rule, the FDA stated that it lacks express statutory authority to require companies to submit GRAS notices. Industry attorneys have flagged this admission, and courts no longer defer to agency interpretations of ambiguous statutes, raising the likelihood of litigation.

In 2021, a federal judge ruled that the FDA had the authority to create a voluntary system — but a mandatory system would be different. Major legal decisions like the major questions doctrine and the Chevron decision have also dramatically reshaped the legal and regulatory landscape.

What’s Next

The FDA will accept public comments on the proposal for 120 days. The agency’s 2026 priority deliverables list GRAS reform as a key initiative, alongside efforts to review food dyes, address ultraprocessed foods, and reduce contaminants in food.

The announcement comes as the U.S. is experiencing one of the largest recorded foodborne illness outbreaks in its history, with confirmed cases of cyclosporiasis topping 10,000. There is also a salmonella outbreak in eggs and jalapeños, leading to a recall of Taylor Farms products sold in 26 states.

Whether the FDA’s legal authority to require mandatory GRAS notification withstands legal challenge remains an open question. What happens to the estimated 10,000 additives already in the food supply — and what the ultraprocessed food definition will actually say when released — are among the key issues to watch in the coming months.

As Medical Daily noted, states have also moved into the gap, with legislation in New York, Pennsylvania, California, and New Jersey that would require companies to report ingredient information at the state level. A patchwork of state disclosure rules is now a realistic near-term outcome regardless of what happens federally.

For consumers, the practical impact of Monday’s announcement may not be immediate. But the proposal represents a significant shift in how the federal government oversees what’s in America’s food — and a key step in the Trump administration’s broader effort to reshape the nation’s food regulatory landscape.