Soup-To-Nuts Podcast: Does FDA’s proposed post-market assessment of chemicals in food fit the bill?

At a public meeting at FDA’s White Oak campus last week, Deputy Commissioner for Human Foods Jim Jones acknowledged shortcomings in the agency’s current post-market safety review process for chemicals in foods and mounting pressure from state legislators and consumer advocates to ensure the safety of the US food supply, including in some cases their efforts to ban additives they deem dangerous. While he also acknowledged states’ rights to prohibit the sale of certain ingredients within their borders, he argued a strong national food safety system is not built state by state, but rather should be led by FDA and based on science.

In this episode of FoodNavigator-USA’s Soup-to-Nuts Podcast,​ regulators, consumer advocates, industry representatives and state legislators gathered at the public meeting explore how FDA could better ensure the safety of the US food system and avoid a pathwork of state regulations. FDA Director of the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition Kristi Muldoon Jacobs shared a high-level overview of how the agency wants to modernize its post-market assessment of chemicals in food along with a rough timeline and milestones for action. Representatives from the Consumer Brands Association, the Environmental Working Group, Center for Science in the public Interest and other stakeholders outline what they like about FDA’s proposal and what they would like to change.

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Much-needed reform could reaffirm FDA’s authority, reassure consumers & industry​

According to stakeholders – including FDA officials – the top pain point with the agency’s current approach to post-market assessment of chemicals in food is that it is not systematic, robust or transparent.

At the public meeting, Deputy Commissioner Jones blamed the current shortcomings in part on lack of authority and resources.

“We have not had a robust post-market safety review program here at FDA. This is largely because there is no statutory requirement for FDA initiated post-market review or for the industry to conduct safety testing and share that data with 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 determinations of safety held up over time. Until now, we have taken an ad hoc approach to post market safety by monitoring the literature and engaging with national and international counterparts to review emerging data as it becomes available,” Jones said.

While additional appropriations for food chemical safety work, including post-market reviews, is not forthcoming, Jones said the agency will do what it can with what it has.

“We sought to reduce the disparity between what is needed to advance our food chemical safety work and what has been historically allocated with the request of $19 million over the FY 23 budget for chemical reassessment. Needless to say, the agency did not see a budget increase. Moreover, because the FY '25 budget was predicated on our receiving FY '24 request, which we did not receive, we are entering another fiscal year where our programmatic needs to meet our public health mandate are greater than our available resources,” he explained.

“Our current budget constraints will limit the number of stated assessments, but you have to start somewhere. We're committed to doing as much as we can with available data, current tools for surveillance signal detection and determining exposure, and we will continue to use our available resources to support the necessary toxicologists, risk modelers and other scientific expertise for this complex work,” he added.

To maximize the limited resources, FDA Director Muldoon Jacobs explained the agency’s proposed systematic process for post-market assessment of chemicals in food builds upon the active post-market programs of well-respected authorities around the world and will lean on new technologies, including machine learning and AI to support its work. It also will be grounded in relevant, data-driven science, she said.

After a signal is identified and validated, FDA proposes to undertake either a “focused” or a “comprehensive” reassessment. Muldoon Jacobs explains the first path would be more appropriate for signals that “can be addressed quickly” while the second path likely would take more time and resources.

When deciding between the two paths, FDA would prioritize reviews based on public health, such as changes in exposure, susceptible subpopulation exposure, toxicity and new scientific information and potential impact. It also would look at external stakeholder activity, other government decisions and public interest.

Industry response: Post-market review could provide regulatory clarity, counter misinformation​

At the public meeting, Consumer Brands Association’s Senior VP of Product Policy and Federal Affairs Sarah Gallo told FoodNavigator-USA that the trade group supports FDA’s commitment to creating a systematic post-market review process that is science-based, data-driven and which could reduce the risk of a patchwork of state laws that would complicate compliance and potentially chill innovation and business development.

“Today’s meeting is not about what is happening in the states, but it is hard to ignore what is happening in the states, and the fact that we had so many attempts within the last legislative session to restrict access or restrict use to ingredients and additives that FDA has determined are safe,” she said. “There is a benefit to elevating FDA as the preeminent food safety authority. When things are safe, and the science dictates things are safe, then it is not helpful to have a state patchwork that is causing consumer confusion.”

Gallo also lauded the agency’s proposed dual assessment paths, noting they should result in more timely action than the agency has taken historically. However, she also said during her presentation at the public meeting, a separate process may be necessary to evaluate unintentionally added or unavoidable environmental contaminants.

She also advocated during the meeting for more details around how FDA would decide when a focused or comprehensive review is the appropriate post-market assessment path, as well as at what point FDA would publicize information and seek public input.

She also lobbied during the meeting for increased insight into realistic expectations about the volume of reviews the agency will conduct and how to track the review process.

Finally, she argued, FDA should clearly communicate to the public about post-markets assessments, which the public could misunderstand prematurely as an adverse safety signal.

“The agency also needs to publicly defend its conclusions and ingredients and the ingredients it has assessed and confirm they are remain safe for consumers,” she added.

FDA officials reiterated multiple times that the agency intends to have the new post-market process up and running by the end of 2025, at which point it will be able to add more color around expected timelines, what it is reviewing and where in the process those reviews are. It also suggested it would not add additional chemicals to its current review list until the new process is in place. The current list includes several substances that are in state legislators’ crosshairs, like Red No. 3 and titanium dioxide. A full list is on its website​.

Consumer advocates: ‘We would really like to see a lot more detail’​

Consumer advocates who presented at the meeting, echoed Gallo’s desire for more details about how FDA will prioritize chemicals for post-market review, how many they will review and how quickly.

“The FDA proposal is pretty thin on details. So, we would really like to see a lot more detail emerge about what the FDA plans to do,” Environmental Working Group VP for Government Affairs Melanie Benesh told FoodNavigator-USA.

“We are in agreement that this needs to be a priority for the agency, but we have a lot of thoughts about the ways that the FDA proposal can be improved, particularly with more opportunities for public input, more clearly established criteria that are tied to public health, more of an emphasis specifically on public health endpoints, and a more clear process for how the FDA is going to actually conduct their safety assessments, what criteria is going to be considered, etc.,” she said.

During the meeting she argued FDA’s plan to prioritize chemicals for review after a focused assessment is “backward” and its proposed focus on new information in prioritizing chemicals could overlook the “whole universe of existing information” about chemicals.

Benesh and a representative from the Center for Science in the Public Interest suggested chemicals should be prioritized based on risk and focus first on those with the most severe outcomes, including carcinogens, concerns for children’s health, immunotoxins, endocrine disruptors, neurotoxins and chemicals causing severe, irreversible organ toxicity. She added chemicals detected in biomonitoring programs should also be prioritized.

Benesh and her co-presenter also took aim at the current GRAS system, which does not require companies that self-determine the GRAS status of a chemical to notify the FDA. While FDA indicated that the post-market review process will include GRAS ingredients, Benesh asked how the agency could review ingredients that companies self-determine as GRAS if it does not know they exist or are in the food supply.

Next steps: Additional comments due by Dec. 6​

FDA’s new Office of Post-Market Assessment will launch Oct. 1 along with the Human Foods Program as the agency kicks off its new fiscal year. And while it does not have all the answers or resources it would like, agency officials at the meeting committed to hearing and incorporating, as appropriate, feedback from stakeholders.

It is accepting additional comments through Dec. 6.

As the agency and industry inch closer to the target goal of launching the post-market review process by the end of 2025, CBA’s Gallo said the industry must continue to listen to what consumers want – noting that companies often can move faster than regulators to remove ingredients of concern as they see fit.

Likewise, she notes, the trade group will continue to advocate for additional resources for FDA with the belief that strong, clear regulations not only make for a safer food system but a better business environment.