FDA Releases Post-Market Assessment Prioritization Tool for Chemicals in the Food Supply

FDA announced last month an initiative to improve the agency’s systematic review of chemicals in the food supply, to include the following key actions:

• A modernized, evidence-based prioritization scheme for reviewing existing chemicals.
• A final, systematic post-market review process shaped by stakeholder input.
• An updated list of chemicals under review, including butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), and azodicarbonamide (ADA).

On June 18, 2025, FDA released the first item on this list: a proposed method for ranking and prioritizing chemicals in the food supply for post-market review. FDA refers to this method as the “Post-Market Assessment Prioritization Tool.” Once finalized, FDA will use this tool to identify the substances it will prioritize for review under its enhanced post-market review process. This enhanced post-market review process, which will build on a discussion paper and public meeting FDA held on this topic in 2024, has not yet been finalized, but FDA has indicated that it plans to release a full description of this process later this year.

What are the core components of the Post-Market Assessment Prioritization Tool?

The Post-Market Assessment Prioritization Tool outlines two sets of criteria under which FDA will rank food chemicals:

1. Public health criteria, which include information on (i) the toxicity of the chemical, (ii) how much of the chemical is consumed, (iii) the degree to the chemical is found in foods intended for susceptible populations, and (iv) whether there is new scientific information that impacts FDA’s risk assessment for the chemical.
2. Other decisional criteria, which include information on (i) the degree to which governmental and non-governmental stakeholders have raised concerns about the chemical, (ii) whether other governmental actors have taken actions to restrict the chemical, and (iii) the degree to which not conducting a post-market assessment of the chemical could impact public confidence in the food supply.

Based on these rankings, FDA will calculate a “Total Public Health Score” and “Total Other Decisional Criteria Score” for each chemical, and will then use those scores to calculate an overall “Post-Market Assessment Prioritization Score.” FDA will then use the Post-Market Assessment Prioritization Score to determine which substances to prioritize for review under its post-market review process.

Stakeholders should note that FDA does not intend to evaluate all chemicals in the food supply using the Post-Market Assessment Prioritization Tool. Rather, FDA plans to first use surveillance and signal detection tools to develop an inventory of chemicals for potential evaluation. FDA will then use the Post-Market Assessment Prioritization Tool to determine which chemicals from that inventory it should prioritize for review.

How can stakeholders provide feedback on the Post-Market Assessment Prioritization Tool?

FDA plans to further update the Post-Market Assessment Prioritization Tool, as necessary, based on both public comments and an external peer review process. FDA is specifically seeking public comment on the following topics:

• Whether or not the modeling approach FDA has proposed is appropriate for the tool’s stated purpose (i.e., assisting FDA in making decisions about which chemicals are a priority to review).
• Whether the proposed public health criteria and other decisional criteria are appropriate for the tool’s stated purpose, and whether there are additional criteria that FDA should consider.
• Whether the public health criteria and other decisional criteria are appropriately defined.
• Whether FDA should give equal weight to each of the public health criteria and other decisional criteria when calculating a chemical’s Total Public Health Score and Total Other Decisional Criteria Score, and whether these two scores should be given equal weight when calculating a chemical’s overall Post-Market Assessment Prioritization Score.
• Whether and how FDA might incorporate new approach methodologies (NAMs) and threshold of toxicological concern (TTC) approaches (including the Cramer classification scheme and FDA’s recently-developed Expanded Decision Tree (EDT)) when assessing toxicity as part of the public health criteria.
• Any other comments on the proposed tool.

Stakeholders have until July 18, 2025, to submit comments.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.