FDA Plans New Post-Market Review Process For Food Chemicals

The FDA says it’s developing a “systematic process” for conducting post-market assessments of chemicals in food. This involves ingredients considered generally recognized as safe (GRAS), such as food additives and color additives, as well as food contact substances and naturally occurring contaminants such as lead and arsenic.

The partial reveal came at a Sept. 25 public meeting on the subject. Read on for more discussion from that meeting, just don’t expect to see the “systematic process” completely fleshed out. And reducing a 3.5-hour meeting to 1,000 words here may not do the subject justice. But note the agency is going to use a little artificial intelligence to help it wade through all the new and often conflicting “signals” on food chemicals.

Growing Pressure On The FDA To Reevaluate Food Additives

The FDA probably has never been under such pressure to reconsider food additives that for decades have been considered safe. Several states have passed or are considering legislation to outlaw some ingredients within their boundaries, members of Congress have criticized the FDA’s current process and many ingredients considered safe in this country have been banned in Europe and other geographies, raising questions here at home.

“We have not had a robust post-market assessment program here at FDA,” admitted Jim Jones, deputy commissioner in charge of the new Human Foods Program. “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.”

FDA’s Limited Resources And Modernizing Food Additive Safety

“Given our limited resources” was restated several times by several FDA officials. Funding looms as a big qualifier of how this process will take shape.

“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 they become available,” Jones continued. “We have taken action to remove additives that no longer meet our safety standards [such as partially hydrogenated oils and brominated vegetable oils].

“We are modernizing our approach because as a society we 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 U.S. food supply,” he said.

The Push For A Strong National Food Safety System

Addressing the elephant in the room, “Over the past few years, there have been an increasing number of state bills to ban certain additives and set limits for certain contaminants. While states are well under their rights under the current regulatory system to do so, a strong national food safety system is not built state-by-state.

“The FDA must lead the way, but to do so, we need to do more,” he said.

But he noted some of the bureaucratic hurdles: “While we have a strong commitment to do more in this space, the reality is our new Human Foods Program did not come with increased budget, added authorities or a change to the legal requirement for industry to conduct and share safety testing with the FDA.

Budget Constraints And Post-Market Review Scenarios

“Simply put, prioritization drive can only take us so far and our budget constraints will limit the number of assessments. But you have to start somewhere. We are committed to do 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 toxicologist risk modelers and other scientific expertise for this complex work.”

Kristi Muldoon Jacobs, the director of FDA’s office of food additive safety, then took over. “We found that most of the post-market work, especially in cases of additives and ingredients, tended to occur under three different scenarios. [1] We would take this work on when it was a subject of a petition or it was a substance that was included in a resubmission for a notification of petition or work of the like. [2] We would see the work in response to great public interest or inquiry. [3] And then also, we would see it initiated by FDA experts when they were monitoring the literature or participating in a publication or at scientific meeting that they thought was worthy of additional review.

Challenges In Post-Market Review Of Food Additives

“We acknowledge we’re living in an information age, and we are often under a deluge of information of varying reliability, and this is presenting a real challenge to our post-market work.” She noted that the National Institutes of Health publishes between 4,000 and 7,000 new scientific articles each day, most of which should be considered for the post-market review process.

“We know there are several other well respected authorities out there that have active post-market programs,” Jacobs continued. “We looked at … the EPA’s TSCA [Toxic Substances Control Act] program, the JECFA [Joint FAO/WHO Expert Committee on Food Additives] program, among others. … We [also] observed an increased need for public input and transparency as part of our process.”

Approaches To Signal Identification And Assessment

She outlined two approaches, “one, focused, the other, more comprehensive.” The process begins with signal identification. “A signal in this context is identified as any information, whether credible or not, from any source, that suggests a public health risk or the need for scientific evaluation. … Because of the sheer volumes of signals, it will be imperative to use technology to enhance the process of sorting them.

“At the triage phase, we aim to utilize a combination of technology and human experts to assist us in identifying information of high quality and high relevance for use in regulatory safety assessments,” Jacobs continued. “These quality signals will then move into a fit for purpose decision.”

Comprehensive Assessments And Stakeholder Engagement

In cases where the signal suggests a more complex and robust assessment is warranted, a comprehensive assessment will be undertaken. “These types of assessments will likely take more than a year to complete and may involve multiple opportunities for stakeholder engagement and input,” she said.

Jones at some point added, “We want your feedback about the proposal made public before we implement an approach,” said Jones. “I expect that with continued engagement with our stakeholders and partners, we will make steady progress toward our goal of enhancing food chemical safety.”

It’s a lot to digest … for stakeholders and the agency itself. To see a video of the nearly four-hour meeting or to read the transcript for yourself, click here. There’s also a link to submit comments.

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Source: Food Processing