FDA’s Plan to Evaluate Chemicals in Food Seen as Lacking Details

Concerns with the FDA’s proposed framework for assessing chemicals in foods already on the market are adding to unease around the agency’s current regulatory practices for food safety.

The Food and Drug Administration’s proposal for reviewing chemicals in food at the post-market stage is spurring some environmental and food groups to urge the agency to review its current actions for regulating food additives and substances.

The draft—for which the agency is accepting comments until December—comes amid the FDA’s largest reorganization, which formed the new Human Foods Program led by Deputy Commissioner Jim Jones. The FDA has faced criticism over its Generally Recognized as Safe (GRAS) process, along with its response time to food or color additive petitions.

The framework will establish a new post-market assessment plan that seeks to improve the previous system that was criticized for being conducted through an ad hoc basis and largely behind closed doors. But consumer advocacy groups and industry members are asking the agency to provide more transparency, emphasizing concerns around the FDA’s current practices and priorities.

“The overarching problem we see is FDA not being proactive enough in how it’s addressing existing concerns,” said Thomas Galligan, principal scientist for food additives and supplements at the Center for Science in the Public Interest.

“The whole discussion paper frames this framework as a forward-looking process that monitors for new information that might emerge in the future, and then the agency will act,” he said. “But the problem with that is FDA’s existing post-market review system hasn’t been working properly.”

An FDA system that allows manufacturers to bypass a two-year approval process for food ingredients, known as GRAS, has been under scrutiny as it allows manufacturers to add new substances to food without agency review.

Companies can self-designate substances as GRAS, showing scientific evidence and consensus that the product is safe. The FDA has a voluntary notification program for companies to submit their GRAS determinations, but there’s not a legal requirement to do so.

A Bloomberg Law investigation published in December 2023 found that the GRAS system led to some people across the US falling ill or ending up hospitalized because of the lack of agency review for chemicals added to foods.

‘Thin on Details’

The FDA held a public meeting in September outlining the development of the post-market assessment.

The agency has lacked a robust post-market safety review program because there’s no statutory requirement under the Federal Food, Drug, and Cosmetic Act for the FDA to conduct safety testing after a chemical is introduced into the market, Jones said at that meeting.

“We are modernizing our approach to post-market chemical safety assessments because we, as a society, have learned much about chemical safety over the past several decades, and in response to growing public demand for the FDA to do more to ensure the safety of chemicals currently in the US food supply,” Jones said.

The plan outlined two approaches for assessing chemicals in food. A focus assessment, which could range from four months to a year, would be limited in scope and conducted without formal external engagement. A comprehensive assessment, which could take years to complete, would be more complex and resource intensive.

Consumer groups and industry members at the meeting shared feedback on the proposed framework, with many comments requesting more details and clarifications on transparency in the review process.

“It’s very thin on details,” Melanie Benesh, vice president of government affairs at the Environmental Working Group, said in an interview.

“There’s a lot more that we would like to see from the FDA—what kind of studies are they going to use when they assess these chemicals? What role is peer review going to play? When is the public going to have opportunities to comment?”

Brian Sylvester, chair of the food regulatory practice at Perkins Coie LLP, said the industry generally supports the effort, but the FDA needs to maintain transparency, make clear which type of assessment is being applied, and provide status updates on the agency’s progress in assessing the ingredient.

“To the extent a particular substance is given visibility as part of FDA’s post-market assessment, there’s a potential for it to be misunderstood by the public as signaling an adverse safety determination which could inadvertently and prematurely stigmatize an otherwise safe ingredient,” Sylvester said.

Pending Petitions

Notably, some groups asked the agency to clarify how it will prioritize requirements under the FDCA.

Tom Neltner, executive director of Unleaded Kids, says the proposed plan “is not consistent with the clear requirements in the statute.”

“They’re ignoring clear statutory mandates,” Neltner said.

He says the plan doesn’t prioritize responding to food additive or color additive petitions, which the FDA is required to reply to in 180 days.

An FDA database last updated Sept. 30 lists 35 food additive and color additive petitions seeking to ban cancer-causing substances including red dye No. 3 and benzene. The petitions are either still under review or held in abeyance, with some dating back to 1990.

Neltner also underscored how the FDCA requires the agency to ban a chemical if it’s a carcinogen and consider the cumulative effect of chemically and biologically related substances in the diet—both of which are not prioritized in the proposed framework.

“It’s important to point out that FDA realizes this and that’s why they are developing this new system,” Galligan said. “FDA should be beginning this process with prioritization because even if they’ve been conducting post-market assessments behind closed doors, the system by which they were doing that was not working properly.”

Kristi Muldoon Jacobs, director for the FDA’s Office of Food Additive Safety, said in the public meeting that the agency benefits from a “clear definition” within the FDCA on how to regulate food and color additives.

“That definition includes clear exclusion and an expectation of safety for all chemicals used or found in food. The regulations direct both industry and FDA in their roles and responsibilities when seeking to use new substances or ingredients in food,” Jacobs said.

Ongoing State Action

The FDA’s work comes as an increasing number of states introduce bills seeking to ban food and color additives, along with setting limits for certain contaminants.

While states are well within their rights to pass such legislation, Jones said, “a strong national food safety system is not built state by state” and that the FDA “must lead the way on food chemical safety.”

Sarah Gallo, senior vice president of product policy and federal affairs for the Consumer Brands Association, said a federal system is needed given the wave of states looking to pass chemical bans.

“Anytime we have this state patchwork where there is conflicting information going out into the marketplace, it really does not send a clear signal to consumers and makes from the industry side a really complicated landscape to put things into the market,” Gallo said.

But Benesh said states should continue to lead the way and take action.

“I would underscore the importance of states continuing to act,” Benesh said. “The meeting did not provide a lot of additional detail about what the FDA is actually going to do and what this program is going to look like, and whether or not it’s going to be successful.”