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The US Food and Drug Administration is moving ahead with a plan to overhaul its food safety efforts, despite a lack of new legal authorities and resources. As part of a reorganization that went into effect Oct. 1, the agency has established an office to conduct postmarket safety reviews of flavors, preservatives, coloring agents, and other chemicals in food.
Thousands of these chemicals are found in processed food, and many have never undergone FDA evaluation because they bypassed premarket review under a loophole that allows companies to declare substances as generally recognized as safe (GRAS) without notifying the FDA.
The agency also does not have a systematic approach for evaluating food chemicals already on the market when new data suggest harmful effects. It hopes to change that by the end of 2025.
At a public meeting on Sept. 25, FDA officials detailed a recent proposal for what a postmarket safety review program could look like. They also listened to feedback from parties including food industry groups, consumer advocates, academics, and state legislators.
The FDA doesn’t already have such a program for food chemicals “largely because there’s no statutory requirement for FDA to initiate postmarket review or for the industry to conduct safety testing and to share that data with FDA after a chemical is introduced into the market,” Jim Jones, the agency’s deputy commissioner for human foods, said at the meeting.
In the absence of federal action, an increasing number of states are passing legislation to ban certain chemicals in food and set limits for contaminants, such as heavy metals. “A strong national food safety system is not built state by state,” Jones said. “The FDA must lead the way on food chemical safety.”
The FDA’s proposal addresses all food chemicals, including colors, food additives, substances in food packaging, GRAS substances, and contaminants that enter food from the environment. The agency plans to use technology such as machine learning and artificial intelligence–based data crawling to capture new information that suggests public health risks associated with these chemicals. It will then triage the information to identify any source that warrants further consideration.
Based on the complexity and type of information, the FDA would then conduct either a quick, focused assessment or a longer, more comprehensive one.
Consumer advocates and others at the meeting urged the FDA to provide more details about the criteria it will use to decide the assessment type and about how it will prioritize chemicals for evaluation.
They also encouraged the agency to consider existing data. “This entire proposal is framed as one that looks forward and monitors for new information and emerging problems,” Thomas Galligan, principal scientist for food additives and supplements at the Center for Science in the Public Interest, said on behalf of an alliance of organizations concerned about chemicals in food. “We would like FDA to act on the existing information that’s already out there.”
Several interested parties, including consumer groups and state legislators, also questioned how the FDA is going to identify GRAS substances that bypassed premarket review.
“Since the year 2000, we know that 99% of the new chemicals that have entered our food supply have done so through the GRAS loophole,” Natalie Mihalek, a member of the Pennsylvania House of Representatives, said at the meeting. Mihalek has proposed legislation to ban a handful of color additives and other food ingredients linked to behavioral issues in children, immune system disruption, and cancer, in food sold in Pennsylvania.
Trade groups representing the food industry say they support the FDA’s effort to establish a postmarket safety review program, claiming it will boost consumer confidence in the food supply and promote a more predictable regulatory landscape. But they worry about premature stigma surrounding chemicals on the FDA’s review list that could lead to unwarranted consumer fear.
“FDA should clearly communicate to the public about any postmarket assessment list it generates and what that signifies,” Sarah Gallo, senior vice president of product policy and federal affairs at the Consumer Brands Association, an industry group, said at the meeting. Gallo also suggested creating a separate process for unavoidable environmental contaminants.
FDA officials at the meeting acknowledged that the agency needs to do more to ensure the safety of chemicals in food. But they also said that, without more money, progress will continue to be slow. It is up to Congress to boost the agency’s budget or give it authority to collect fees from industry to pay for the review of food ingredients.
The FDA is accepting public comments on its proposal until Dec. 6.
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