FDA proposes mandatory notice for new food ingredients

Rule omits long-promised ultra-processed foods definition

The proposed rule, submitted to the Federal Register on Monday, would require companies to submit to the FDA all ingredients in foods brought to market under the Generally Recognized As Safe pathway — a framework created in 1958 that was meant as an exemption but became the main way new substances entered the U.S. food supply. The pathway allowed food companies to use ingredients proven safe either through scientific research or because they were already commonly used, and it greatly outpaced the food additive petition pathway, acting FDA Commissioner Kyle Diamantas said on a press call Monday.

“If finalized, this rule would formally transition the Gras framework from a voluntary program to a mandatory notification system,” Diamantas said. It would apply to all ingredients currently on the market using the framework, in addition to new ingredients coming out.

Under the current system, companies can decide for themselves whether an ingredient is “generally recognized as safe,” with no requirement to notify the FDA or submit evidence, although some do. The proposal would require companies to document and submit their safety findings for new ingredients, giving regulators the opportunity to investigate if they see a potential safety risk.

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

The proposal does not encompass the administration’s broader promises to reform food regulations. Robert F Kennedy Jr, secretary of the U.S. Department of Health and Human Services, had promised a definition of ultra-processed foods “by April,” but Diamantas said that month that “a definition for ultra-processed foods is really hard.”

There is no scientific consensus on what “ultra-processed foods” are, and it has been difficult to ascertain whether they have negative health effects, as Kennedy has repeatedly claimed. The Make America Healthy Again movement rose to prominence alongside public concern about food additives and a lack of transparency about the U.S. food system, according to media accounts of the movement’s appeal.

Diamantas said the HHS and the U.S. Department of Agriculture have submitted a proposed definition “aimed at creating a stronger foundation for future federal nutrition research.” He said additional information on ultra-processed foods “will be shared at a future time.”

Marion Nestle, professor emerita of nutrition, food studies, and public health at New York University, questioned the delay and the missing definition. “You have to be kidding. That’s all?” she asked, wondering what took so long for “something so simple and obvious” as closing the loophole and where the proposed definition of ultra-processed foods was — a long-awaited announcement promised earlier this year.

Amaru Sanchez, a food and agriculture lawyer at Akin Gump Strauss Hauer & Feld, said the proposal is “a huge deal for the food industry.” It would have ripple effects throughout the food system, with suppliers, companies, retailers and consumers scrambling to understand what the proposed regulation would mean for them, he said.

Sanchez said it is not clear whether the FDA has the regulatory authority to require the notification. “It really is the question on everyone’s mind,” he said. In 2021, a federal judge ruled that the FDA had the authority to create a voluntary system, but a mandatory system would be different, Sanchez said. He added that other major legal decisions, including the major questions doctrine and the Chevron decisions, have dramatically reshaped the legal and regulatory landscape.

Nestle said that if the new rule is implemented, “mandatory notification of new additives is an improvement, but the company is still responsible for the science and will still be hiring its own experts to say the additive is safe.” Reviewing the notifications and deciding whether the scientific proof of safety is adequate could put strain on FDA staff, who have suffered layoffs and low morale under the Trump administration, she said. She also asked what happens if the FDA rejects a company’s submission. “Does that mean the company cannot use the additive?” she said.

The agency will also publish new guidance on biological hazards in ready-to-eat fresh-cut produce on Tuesday, officials said. The rule arrives as the U.S. experiences one of the largest recorded foodborne illness outbreaks in its history, with confirmed cases of cyclosporiasis topping 10,000. A separate salmonella outbreak in eggs and jalapeños led to a recall of Taylor Farms products sold in 26 states.