On June 18, 2025, FDA announced for public comment a Post-market Assessment Prioritization Tool (Prioritization Tool) as an enhanced systematic process for post-market scientific assessment of chemicals in food, including food additives, color additives, GRAS ingredients, and food contact substances. The announcement is the agency’s latest step in its effort to modernize the framework for identifying and prioritizing substances in food for review based on public health concerns. FDA is soliciting public comment on the Prioritization Tool.
Development of the Prioritization Tool
The Prioritization Tool was developed following FDA’s August 2024 discussion paper on systematic post-market assessment of food chemicals, which consists of steps including signal detection, triage, prioritization, scoping, scientific assessment, risk management review, and risk management action. Piloted in 2024, the Prioritization Tool was the subject of a September 2024 public meeting. The June 2025 announcement further details the methodology in the current iteration of the Prioritization Tool, for which FDA is also seeking public comment.
Structure of the Prioritization Tool
The Prioritization Tool utilizes a Multi-Criteria Decision Analysis (MCDA) framework to assess and score food chemicals according to two broader categories of criteria: public health and other decision criteria.
With respect to public health criteria, FDA scores food chemicals based on the toxicity, change in exposure, susceptible subpopulation exposure, and new scientific information related to the chemical.
- Toxicity: Toxicity is assessed via a rubric encompassing seven toxicity data types, including acute toxicity, carcinogenicity, developmental and reproductive toxicity, neurotoxicity, other organ-specific toxicity, immunotoxicity, and bioaccumulation. The highest single data score determines the overall toxicity score.
- Change in Exposure: Change in exposure considers whether data indicates increased dietary exposure levels, production volumes, or consumption patterns since the last assessment of the ingredient.
- Susceptible Subpopulation Exposure: This subfactor assesses the likelihood of the chemical’s presence in the products consumed by vulnerable groups such as infants and children.
- New Scientific Information: New scientific information includes and evaluates the potential impact of new toxicity data or analytical detection capabilities on prior safety conclusions.
Other decision criteria include external stakeholder activity, other governmental actions, and public confidence considerations.
- External Stakeholder Activity: External stakeholder activity includes the degree of public, legislative, and stakeholder attention directed toward the particular chemical.
- Other Governmental Actions: Actions include regulatory decisions or other activities undertaken by other federal, state, or international authorities with respect to the chemical.
- Public Confidence Considerations: These considerations assess the potential risk to public trust in the food supply if a post-market assessment is not conducted.
Calculation of Prioritization Scores
Each of the above criterion is scored on a numerical scale (from 1 to 9), with higher values indicating greater concern or impact. For each chemical, a total public health criteria score is calculated by summing the weighted scores for the four public health criteria. A total other decisional criteria score is calculated by summing the weighted scores for the three other decisional criteria. An overall post-market assessment prioritization score is derived by combining the total scores from both categories, with equal weighting proposed for both categories in the current draft of the tool. The resulting scores rank chemicals in order of priority for post-market assessment, although the scores themselves, according to FDA, do not constitute a health risk determination.
Conclusion
If the tool is finalized and implemented to create a priority list of food chemicals to be reviewed for safety, that alone will create disruption to the supply chain, food development and formulation, and result in re-labeling issues. Industry groups and individual companies will need to strategize on the cost and time to defend the safety of a substance, or to move on to finding appropriate and safe substitutes. The priority list will be an important driver to future ingredient availability and the food industry and companies should ensure the process is rational and comprehensive, taking into consideration the proper weighting of the categories in the scoring system.
FDA has invited public comment on the draft scoring system tool, which will also undergo external peer review in fiscal year 2025. Specifically, FDA has requested public comment on the appropriateness of the modeling approach and criteria, and the possible incorporation of new approach methodologies and other toxicological tools. Stakeholders are invited to submit comments before the comment period closes on July 18, 2025.