Highlights
- The U.S. Food and Drug Administration (FDA) proposed the use of a new, systematic tool to guide how it will rank and prioritize substances in food for post-market safety reviews.
- The Post-Market Assessment Prioritization Tool will, if implemented, be integrated into a broader, proactive post-market surveillance program that leverages advanced data analytics and expert evaluation to identify and review food chemicals determined to be of greatest potential concern.
- The agency is seeking public input on the draft tool and related regulatory changes, signaling increased transparency, potential revisions to the generally recognized as safe (GRAS) process and heightened expectations for industry engagement and compliance.
- Companies and stakeholders should closely monitor these developments, review their portfolios for chemicals that may be subject to increased scrutiny and prepare for enhanced transparency and data requirements.
The U.S. Food and Drug Administration (FDA) is overhauling its approach to post-market oversight of food chemicals, marked by the proposed rollout of a new Post-Market Assessment Prioritization Tool. The FDA first announced its plans to revamp food safety oversight in the U.S. through systematic review of the safety of chemicals already in the nation's food supply in May 2025. (See Holland & Knight's previous alert, "FDA Initiates New Post-Market Review Framework for Food Chemicals," May 22, 2025.)
The new prioritization tool is designed to bring a "science-based, data-driven, systematic, and reproducible" framework to the process of determining which food chemicals – whether intentionally added, present as contaminants or used in food contact materials – should be targeted for a post-market safety assessment based on the risk a chemical allegedly poses to public health. The framework aligns with principles used by other global authorities, including the European Food Safety Authority's (EFSA) reevaluation of legacy additives and Toxic Substances Control Act's (TSCA) prioritization under the U.S. Environmental Protection Agency's (EPA) risk-based approach.
Structure and Criteria of the New Tool
The tool will employ a Multi-Criteria Decision Analysis (MCDA) approach, allowing FDA subject matter experts to score chemicals based on two main sets of defined criteria:
- Public Health Criteria – includes toxicity (assessed across seven data types), changes in exposure, relevance to susceptible subpopulations (such as infants) and the presence of new scientific information
- Other Decisional Criteria – will capture the level of external stakeholder attention, actions by other governmental agencies and the potential impact on public confidence in the food supply; includes alignment with state-level bans, international decisions under the U.S. Codex Office or European Union's (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), and emerging science-policy interfaces such as endocrine disruption criteria
Each criterion is scored on a standardized scale, and the overall prioritization score is calculated using equal weighting, though the methodology is proposed to be flexible and accommodate alternative weighting schemes based on stakeholder input. The methodology will look similar in practice to the one the EPA uses for prioritizing chemicals. The FDA has indicated the scoring algorithm may incorporate additional metadata from chemical databases such as the Integrated Risk Information System (IRIS) and European Chemicals Agency (ECHA) dossiers in future iterations.
Alignment with EPA's Prioritization and Modernization Effort
The FDA's proposed prioritization tool shares conceptual and methodological similarities with the EPA's chemical prioritization process under the TSCA. Like the EPA's framework, which designates chemicals as either high or low priority for risk evaluation based on hazard, exposure, persistence and bioaccumulation, the FDA's tool incorporates a structured, criteria-based approach to triage substances for further review. Both agencies emphasize that a high-priority designation is not a risk determination but rather a resource allocation mechanism to focus scientific evaluation on chemicals of greatest potential concern.
The FDA has also signaled interest in incorporating information from new approach methodologies (NAMs) in its review, leveraging its interagency experience and the EPA's experience with read-across techniques – tools increasingly used by the EPA to assess structurally similar chemicals with limited data. These cross-agency synergies are further supported by collaborative initiatives such as Tox21 and Accelerating the Pace of Chemical Risk Assessment (APCRA), which aim to modernize chemical safety evaluations through shared data, predictive modeling and reduced reliance on animal testing.
Integration into FDA Surveillance and Review Workflow
The prioritization tool will be fully integrated into the FDA's broader post-market surveillance process. The workflow will begin with signal detection, where the agency uses advanced surveillance and data analytics – including machine learning – to identify chemicals that may pose emerging risks. Once a chemical is flagged, it will be triaged and entered into an inventory for potential review. Subject matter experts then apply the tool to score and rank chemicals, generating a prioritized list that informs which substances should proceed to more detailed scientific assessment and, if necessary, regulatory action.
Importantly, a high prioritization score does not itself constitute a finding of risk but rather serves as an internal mechanism to focus FDA resources on chemicals of greatest potential concern. To start, the proposed tool will focus evaluation efforts on particular chemicals that are candidates for post-market assessment. Criteria for selection into the inventory include detection in multiple commodities, increasing consumption trends or recent generally recognized as safe (GRAS) notifications.
Implications for GRAS Determinations and Synthetic Dyes
In the announcement, the FDA also indicates consideration of changes to the GRAS process, with plans to require FDA review of all GRAS determinations and phase out petroleum-based food dyes by the end of 2026. A detailed transition timeline for synthetic dyes is anticipated later this year and may require premarket notifications or reformulation guidance for affected categories.
Public Engagement and Next Steps
The agency published the draft prioritization tool for public comment, with the current comment period open until July 18, 2025. The FDA is also convening expert panels on high-priority topics and actively seeking input from industry and consumer groups to ensure that the new tool incorporates the consideration of appropriate Public Health and Other Decisional criteria and that regulatory processes are robust, credible and responsive to evolving scientific and societal concerns. The agency has encouraged submission of chemical-specific data, exposure estimates and risk prioritization models during this period.
What Companies Should Do Now
Companies should closely monitor these developments, review their portfolios for chemicals that may be subject to increased scrutiny and prepare for enhanced transparency and data requirements. Active participation in public comment opportunities and expert panels will be critical for shaping the final Post-Market Assessment Prioritization Tool and ensuring that the FDA is responsive to industry feedback and perspectives. The developments in recent months mark a pivotal time for food regulation in the U.S. The proposed new frameworks could influence everything from ingredient labeling to product liability exposure and class-action risk.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
