KANSAS CITY — State laws, the incoming Trump administration and a new US Food and Drug Administration program to investigate chemicals in food all may impact food ingredient regulations in 2025.

“Historically, regulatory focus in the United States has been more on microbes than on chemical residues,” said David Acheson, MD, president and chief executive officer of The Acheson Group and who previously worked at both the FDA and the US Department of Agriculture.

The FDA appears to be changing.

The agency is developing a post-market assessment for chemicals in food. The assessment will include ingredients considered Generally Recognized As Safe (GRAS), food additives, color additives, food contact substances and contaminants. Processing aids are included.

The FDA will take a two-pronged approach: focused assessments and comprehensive assessments. For ingredients in focused assessments, “the agency feels like there is some information, but they are not overly worried about it,” said Claudia Lewis, co-chair of Venable LLP’s FDA group. For ingredients in comprehensive assessments, the FDA will “dig deeper,” she said. Questions may arise over whether the ingredient needs to be limited in terms of consumption within an age group or limited at a certain level within a food product.

The FDA allowed public comments about the post-market assessment in a Sept. 25 meeting.

“We have not had a robust post-market assessment program here at FDA,” Jim Jones, the FDA’s deputy commissioner for human foods, said in the meeting. “This is largely because there’s no statutory requirement for FDA’s post-market review or safety testing to share that data with the FDA after a chemical is introduced into the market. As such, given our limited resources, the agency has not established a systematic process to ensure that our original determination of safety held up over time.”

He added, “We are modernizing our approach because we have as a society, we have learned much about chemical safety over the past several decades.”

During the meeting, discussion focused on ingredients and other substances like sweeteners, synthetic colors like red 3 and yellow 5, potassium bromate, heavy metals like cadmium and lead, and caffeine in energy drinks. Some speakers questioned whether the FDA needs to overhaul its GRAS program.

In the Nov. 21 Federal Register, the FDA extended its public comment period on the post-market assessment to Jan. 21, 2025.

“I think that this is going to be an ongoing process,” Lewis said. “As science changes, new information emerges. There is a lot of innovation in the food space. We’re constantly looking to different preservatives. There are different ways of manufacturing products. So, the way I look at the regulatory process is, it’s sort of a living, ongoing journey.”

California’s actions

The state of California already acted on chemicals in food. California Governor Gavin Newsom signed Assembly Bill 418 into law on Oct. 7, 2023. The legislation will ban the use of red 3, brominated vegetable oil, potassium bromate and propylparaben on Jan. 1, 2027. The California School Food Safety Act, signed into law by Newsom on Sept. 28, 2024, prohibits California public schools from grades 1 to 12 from serving food containing six synthetic food dyes: blue 1, blue 2, green 3, red 40, yellow 5 and yellow 6. The law becomes effective Dec. 31, 2027.

Food and beverage manufacturers may find it difficult to make different products for California than for the rest of the country, and bills in other states like New York, Illinois and Washington also seek to ban ingredients, Acheson said.

“When you end up trying to regulate or produce food that has arguably 50 different ways of what you’re allowed to do in the US, it becomes unattainable,” he said.

He likened the situation to the previous decade when Vermont sought to regulate food items with genetically modified organisms (GMOs). The federal government in response created the national mandatory bioengineered (BE) food disclosure standard.

A new administration

How will the Trump administration impact the FDA and its approach to state laws? Lewis said she should know more 100 days into the second presidency of Donald J. Trump.

“There is so much noise out there that I can’t really home in on what the new administration is really saying versus what media is just reporting,” Lewis said. “Right now, I feel like sort of blinded, but if I were to go back to tradition, (Republican administrations) are typically less enforcement (oriented) than Democratic administrations.”

Mixed signals are out there. Trump has appointed Elon Musk and Vivek Ramaswamy to lead the Department of Government Efficiency, which will consult on how to reduce federal government spending, but Trump has nominated Robert F. Kennedy Jr. to lead the US Department of Health and Human Services. Kennedy has said he wants to “make America healthy again.”

“Reduce costs, reduce regulatory oversight — but at the same time we want to test for more chemicals,” Acheson said. “Ka-ching. Dollar signs. It’s all this regulatory oversight of some of these things. Well, that’s going in the opposite direction of deregulation.”

The FDA has not received a budget increase for its post-market assessment for chemicals in food.

“They don’t have unlimited dollars,” Lewis said. “They don’t have unlimited persons to look at all these things.”

Acheson summarized what will be needed in assessing chemicals in food.

“It cannot be quick, and it won’t be easy, and I think we have to balance true public health risks with the economic consequences of overreacting and doing things to the food supply that will actually reduce the ability for people to find affordable food,” Acheson said. “That’s a much bigger consequence, I think, in the long run.”