FDA Seeks Public Comment On Post-Market Chemical Review Prioritization Method

Key Takeaways

• What Happened: The U.S. Food and Drug Administration(FDA) released its draft post-market chemical review prioritization method for public comment. Public comments are due July 18, 2025.
• Who is Impacted: Food and chemical manufacturers, including suppliers of food additives and ingredients, color additives, and substances used in food‑contact materials.
• What Should You Do: Food and chemical manufacturers potentially affected by the proposed method should consider submitting comments by July 18.

Background

On June 18, 2025, FDA announced that it is seeking public comment on its proposed method to rank existing food chemicals for post-market assessment. The proposed prioritization method seeks to "develop a science-based, data-driven, systematic, and reproducible process" for prioritizing chemicals for post-market review.

B&D recently discussed FDA's broader plans to overhaul its post-market review program for food chemicals. As part of its effort to develop a more systematic approach to reviewing chemicals in the food supply, FDA is developing a method that will guide how FDA chooses which existing chemicals to prioritize for review. The Agency would use this method to identify chemicals in food for review, including food additives, color additives, generally recognized as safe (GRAS) substances (including those that food and chemical manufacturers have not disclosed to FDA), food contact substances, and chemicals that are present as unintentional contaminants.

FDA would implement the proposed method following these steps:

1. Develop an inventory of chemicals to prioritize.
2. Score each of those chemicals based on a set of criteria.
3. Using those scores, rank each chemical based on a total risk score.
4. Use the rankings to identify which chemicals to prioritize for assessment.

FDA Proposes Specific Criteria to Rank Prioritization

FDA's proposed method would score seven total criteria across two categories:

• Public health criteria, which would weigh (1) the chemical's toxicity, (2) levels of consumption, (3) new scientific information about the chemical, and (4) if vulnerable populations are likely to consume the chemical.
• Other decisional criteria, which would weigh (1) concerns raised by the public, (2) other government agency actions (including from local, state, international, and other federal agencies), and (3) if failure to conduct a review would impact public confidence in the food supply.

FDA would give equal weight to the four public health criteria scores, and the weighted sum would calculate a Total Public Health Criteria Score. FDA would also give equal weight to the three other decisional criteria scores and sum the weighted scores to calculate a Total Other Decisional Criteria Score. Equally weighted and summed together, the two scores would calculate a final overall Post-market Assessment Prioritization Score. The proposed method would result in each of the other decisional criteria scores having slightly more individual weight in the overall score than each of the individual public health criteria scores.

Next Steps

FDA seeks public comment on the following questions:

• If the proposed modeling approach is appropriate to achieve FDA's stated purpose of making decisions about which chemicals to prioritize for review.
• If the proposed scoring criteria are appropriate for FDA's stated purpose and if there are any other criteria FDA should consider.
• If the definitions for the proposed scoring criteria are appropriate for the method.
• If FDA should equally weigh the respective scoring criteria when calculating a Total Public Health Score and a Total Other Decisional Score, and then if FDA should equally weigh both of those scores when calculating an overall score, as proposed, or if FDA should weigh the criteria differently.
• How the chemical toxicity criterion score rubric might incorporate new approach methodologies and threshold of toxicological concern approaches.
• Any additional comments.

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