GRAS update proposal coming this spring, says FDA food chemical safety chief - C&EN

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Key Insights

• Mark Hartman, the Food and Drug Administration’s director for food chemical safety, recently told the chemical industry when it can expect to see the agency’s proposed rule updating the Generally Recognized as Safe (GRAS) system for new food ingredients.
• The food industry anticipates that retroactively proving the safety of ingredients that have been used for decades could impose a significant burden on companies that must comb through old records.
• Most US adults want companies to disclose more information about food ingredients and want government to do more to regulate harmful chemicals, according to a recent Pew Charitable Trusts survey.

One of the first promises that Robert F. Kennedy Jr. made after becoming secretary of the US Department of Health and Human Services (HHS) was to reform the way many food ingredients enter the market.

The Food and Drug Administration currently allows companies to self-affirm that an ingredient is Generally Recognized as Safe (GRAS) and begin using it in food products without FDA review. In March 2025, Kennedy directed the agency to explore rulemaking to eliminate this self-affirmation pathway. Instead, he wants to require companies to notify the FDA in advance when they intend to introduce new ingredients, and to provide data showing those ingredients are safe.

A draft of that much-anticipated rule will be released in the late spring or early summer, according to Mark Hartman, the FDA’s director for food chemical safety. He spoke about the agency’s changing approach to food ingredient oversight at the American Chemistry Council’s GlobalChem conference Feb. 24. The draft GRAS rule is currently under review at the White House Office of Information and Regulatory Affairs, having already gone through one round of feedback. Hartman expects the review to finish in the coming weeks.

Hartman acknowledged the scale of what has become known as the “GRAS loophole.” When FDA officials are asked how many GRAS substances are now in the food supply, they cannot answer. “No one knows,” he said. “We lack visibility into what’s in the marketplace.”

A system for postmarket food ingredient reviews

Food chemical regulation is proving to be a rare area of policy continuity between the previous and current US administrations. Hartman took on his role in 2024 under the Joe Biden administration, which reorganized the FDA to create a Human Foods Program.

That administration had tasked the program with systematically assessing ingredients already on the market, including GRAS substances. This initiative is still underway, independent of the upcoming GRAS rule. A white paper describing this postmarket assessment system is currently being reviewed by FDA and HHS officials and will probably also be published this spring, according to Hartman.

“It’s going to be a living process,” and things may change as the FDA starts reviewing chemicals through this new approach and learns from the experience, he said.

In the meantime, the agency will continue to review individual ingredients in response to stakeholder petitions, as with a recently announced reassessment of butylated hydroxyanisole, commonly known as BHA.

“For the foreseeable future, I think we’ll be doing somewhat of a parallel process,” Hartman said, though he had a message for those who might file new petitions: “Please give us a chance to let this systematic review process take hold,” he said. “Every time we get a petition, it’s something that we have to respond to, and it does take away from our ability to take the steps we’re trying to take.”

There’s public appetite for the government to tackle these issues, according to recent polling.

About half of US adults, 49%, are “very concerned” about harmful chemicals in food, and another 29% are “somewhat concerned,” according to a Pew Charitable Trusts survey of more than 5,000 people published on Feb. 26. Most of the people surveyed, 84%, say the government “needs to do more to identify and regulate harmful chemicals found in everyday products.” And 83% of those surveyed want companies to tell them more about what chemicals are in their products so that consumers can make “informed choices.”

Food industry prepares for retrospective GRAS rule

The food industry is anxious to see the proposed GRAS rule. Industry representatives at GlobalChem expressed concern that the rule might require manufacturers to retroactively prove the safety of ingredients they’ve been using for many years.

“Potentially you’re looking multiple decades backwards, going into hard-copy files,” said Deborah Attwood, global regulatory compliance leader at the specialty chemical company W. R. Grace.

“It’s not like companies keep a GRAS drawer,” said Joseph Dages, a partner at the law firm Steptoe who represents clients in the food industry.

Both advised companies to start going through their records now.

Hartman acknowledged the anticipated challenge but said he expects most companies to be able to support their existing GRAS determinations. “We may have a very naive position at the agency, but we believe that everyone is complying with the law and will have ready at their fingertips the records which support the continued use of substances that they’re selling,” he said.

There’s a “nexus” between GRAS reform and the postmarket assessment program, Hartman added. “However GRAS reform ultimately looks, there’s definitely this notion that it would feed into the postmarket process.”

Once the agency’s draft GRAS rule passes through White House review, the full proposal will be published in the Federal Register for public comment.