On June 18, 2025, FDA published a proposed “Post-Market Assessment Prioritization Tool” to guide how the agency plans to rank and prioritize food chemicals under its enhanced post-market review process.
FDA’s unveiling of this proposed tool comes amid a food regulatory landscape colored by the rise of the president’s Make America Healthy Again (MAHA) movement, the recent creation of FDA’s Human Foods Program (HFP), heightened consumer concerns around so-called ultra-processed foods, and an increasing patchwork of state food additive and color additive bans. For example, in the 2025 legislative session alone, West Virginia, among other states, banned seven food dyes. Texas will also soon require a warning label for foods that contain certain ingredients and additives.
FDA’s Increased Focus on Post-Market Assessment
FDA’s newly proposed Tool reflects ongoing efforts to rethink and reprioritize food chemicals. As background, in September 2024, FDA held a public meeting on the development of an enhanced systematic process for post-market assessment of chemicals in food, namely, food additives, color additives, generally recognized as safe (GRAS) substances, substances used in contact with food, and chemicals present as unintentional contaminants. The meeting followed FDA’s publication of a discussion paper on the same topic and FDA’s prior launch of a public inventory of certain food ingredients that the agency has determined are unsafe because they are unapproved food additives that are not GRAS when used as intended.
On January 15, 2025, FDA announced the revocation of authorization for use of erythrosine (i.e., Red No. 3) in foods. In April 2025, FDA requested that manufacturers work towards voluntarily phasing out synthetic color additives. And, in May 2025, FDA announced an initiative to improve the agency’s systematic post-market review of chemicals, with the first action being the newly proposed Post-Market Assessment Prioritization Tool.
FDA’s Newly Proposed Tool in a Nutshell
FDA intends to use this Tool to identify the substances it should prioritize for review going forward. The Tool will establish prioritization scores determined by evaluating “Public Health” and “Other Decisional” criteria, including:
For each chemical, FDA will calculate a Total Public Health Criteria Score and a Total Other Decisional Criteria Score. These scores are, in turn, used to calculate an overall Post-Market Assessment Prioritization Score.
To develop an inventory of candidate chemicals for prioritization and potential evaluation utilizing the newly released Tool, FDA plans to utilize well-established surveillance and signal detection techniques. Upon creation of this inventory, FDA will then utilize the Tool to determine which chemicals it should prioritize for review based on the Post-Market Assessment Prioritization Score generated by the Tool. FDA explains that “the higher the total score, the higher the priority of that chemical for post-market assessment.” Importantly, the score a chemical receives and the ultimate position of that chemical in the prioritized list generated by the Tool does not reflect FDA’s evaluation as to whether that particular chemical poses a public health risk. Instead, as FDA explains, the potential impact to public health of exposure to any chemical through food will continue to be determined during FDA’s pre- and post-market risk/safety assessment processes.
FDA currently seeks public comment on the following questions through July 18, 2025:
- Whether the proposed modeling approach is appropriate to assist in making decisions about which chemicals are a priority to review.
- Whether the Public Health and Other Decisional criteria are appropriate for the tool’s stated purpose, and whether there are any additional criteria that should be considered.
- Whether the draft scoring definitions for all criteria are appropriate for the purpose of the tool.
- Whether the equal weighting of all criteria and between the Total Public Health and Total Other Decisional Criteria Scores is appropriate. Specifically, FDA asks whether different weights should be applied and why.
- How FDA can consider incorporating information from new approach methodologies (NAMs) and Threshold of Toxicological Concern (TTC) approaches into the toxicity rubric. Per FDA, TTC approaches can be used to assess the toxicity of chemicals that lack sufficient safety data and have low dietary exposures. In addition to the Cramer classification scheme, which has historically been used in TTC approaches, FDA recently developed the Expanded Decision Tree (EDT) that assigns chemicals to one of six EDT classes and is now seeking comment on how such tools or information might be incorporated into the toxicity rubric.
- Any additional comments on the tool.
Next Steps
FDA’s release of its Post-Market Assessment Prioritization Tool marks an important step in the evolving food regulatory landscape. Given the dynamic MAHA-aligned state legislative efforts, voluntary FDA phase-outs, and increasing litigation surrounding the healthfulness of food additives, food industry stakeholders face increasing pressure to anticipate and adapt to changes. Industry input during the comment period may influence the final methodology, making it a critical opportunity for regulated industry to weigh in and shape FDA’s approach.
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