In previous TAG Insights articles, we’ve discussed that FDA’s focus on chemicals in food seems to be more reactionary than preventive, following state regulations with federal proposals or reacting to media and social media pressure. In a September 30, 2024, public meeting, it was evidenced that our assessment was right on point. As stated by FDA Director, Office of Food Additive Safety, Kristi Muldoon Jacobs the agency currently has no systematic process for post-market assessment of chemicals in food. Rather, she said, it tends to be ad hoc and reactive, thus not necessarily focused toward issues of the greatest public health impact.
To address that, the public meeting, “Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food,” and its accompanying discussion paper were intended to bring the proposed process, while still in its early stages, to stakeholder attention with the express purpose of getting feedback.
With a primary principle of the process being that it be science-based, reproducible and reliable, a post-market assessment process could be focused or comprehensive. To determine which direction it would take, FDA would review the information based on three factors:
- Food Chemical Signal Monitoring. Identification of new information through monitoring of multiple sources (e.g., new submissions to FDA, scientific publications, international and U.S. regulatory activities, adverse event reports, news reports, trade press, and social media).
- Triage. A preliminary quality and impact assessment of information obtained through the food chemical signal monitoring to determine the need for post-market assessment.
- Fit for Purpose Decision. Determination on conducting a focused or comprehensive Assessment, based on the likely complexity.
Both the focused and comprehensive assessment would include a scope/problem formulation, scientific assessment of both risk and safety, risk management review, and public communication and risk management action. But the comprehensive assessment would go further in each of these steps and also include prioritization (ranking individual chemicals to determine their relative priority), involve the public on a draft scientific assessment, brief and gain concurrence from FDA Human Foods Program (HFP) Leadership, and provide opportunity for public comment if applicable.
The greatest differences between the two are the addition of the initial prioritization step in comprehensive, the level of public involvement, and the depth of the scientific assessment. In the focused assessment, FDA will assess whether new information about a chemical suggests a possible safety concern; determine if substances or ingredients intentionally added to food continue to meet the “reasonable certainty of no harm” standard or if actual or estimated exposures exceed a safe level; and if information on a contaminant(s) suggests a public health concern.
In the comprehensive scientific assessment, FDA will first consider relevant external feedback gathered in the Scope/Problem Formulation stage, then assess whether available information suggests a safety concern. The assessment may then evaluate the nature of adverse health effects associated with the identified hazard(s) and population(s) of concern; assess the anticipated dietary exposure and the risk from exposure to the hazard(s); and Identify data gaps or research needed to support the assessment. In addition to determining if intentionally added substances or ingredients meet the “reasonable certainty of no harm” standard, FDA will assess the risk of a contaminant in food to determine if the presence needs to be limited or reduced to assure safety and engage the public on a draft of the scientific assessment.
With its aim of ensuring the new post-market process is science-based, data-driven, systematic, and reproducible, FDA is seeking to develop an objective but flexible risk prioritization based on a Multi-Criteria Decision Analysis (MCDA) method. In this approach, the higher the total score of a chemical, the higher the priority for further review of the chemical, with the primary focus being risk to public health.
Thus, FDA’s tentative vision is that a chemical would receive a higher public health score when the toxicity of the chemical is severe with potentially life-threatening adverse health effects; changes in exposure have occurred; the chemical is found in or could be present in food intended for vulnerable subpopulations; and newly available information, data, or science indicates a potentially significant impact on the conclusions of the previous assessment of the chemical.
While the discussion paper also mentions that it may consider public/organization interest in a particular chemical, this is set as a subpoint of other potential criteria that may be considered.
Frequently mentioned in the public meeting, and the discussion paper, was a goal of transparency and public input, however the need to balance that with FDA resources must also be considered.
Following the FDA discussion of the proposed process, a number of organization representatives, politicians, and public persons provided their input, based also on the discussion paper which was provided prior to the meeting and the meeting. Much of the comment focused on FDA providing further detail to steps of the proposed process, additional public communication and opportunity for comment throughout, and overall transparency. Portions of the public input also shifted toward questions on further regulation of GRAS substances, with FDA noting that while these will be included in the assessments, GRAS is based on a Congressional law with no FDA approval required, so FDA has limited ability to regulate these.
As stated at the beginning of this article, we have previously expressed our concern about FDA following rather than leading in areas related to chemicals in foods. So, it is good to see that the agency is admitting that its post-market chemical assessment is “currently ad hoc,” but it is working to change that to a systematic, science-based process of assessment. FDA has certainly made it clear that they are embarking on a process to look at public health risks associated with chemicals. How quickly it goes from here is yet to be seen, but we anticipate it will likely be very slow and not stem the tide of state-driven legislation. Thus, while the FDA process moves along, we would recommend that manufacturers not only stay attuned to developments, but also conduct your own product and supply assessments to determine any potential impacts should FDA’s assessment result in a ban of a chemical for which your products are at risk. Meanwhile, stay informed on state-driven legislation which can impact your ability to market goods in different states.
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