On May 12, 2026, the U.S. Food and Drug Administration (FDA) announced a major milestone in its approach to post-market oversight of chemicals in the food supply, finalizing a new proactive food chemical safety post-market assessment program and releasing two foundational papers: the “Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food” and the “Tool for the Prioritization of Food Chemicals for Post-Market Assessment.”
At the same time, FDA initiated assessments of butylated hydroxytoluene (BHT) and azodicarbonamide (ADA) and issued Requests for Information (RFIs) seeking updated data on their uses and safety. Notably, ADA has been the subject of sustained focus, and much of the U.S. baking industry has already moved toward voluntarily phasing-out the use of it in recent years.
Taken together, these actions reflect the culmination of FDA’s multi-year effort to establish a more systematic, risk-based and transparent framework for evaluating chemicals already in the food supply including food additives, color additives, generally recognized as safe (GRAS) substances, food contact substances and chemical contaminants. They also align with the broader federal food policy priorities and the administration’s Make America Healthy Again (MAHA) agenda.
The Enhanced Systematic Process
FDA’s Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food establishes an end-to-end lifecycle for identifying, prioritizing, assessing, and managing potential safety concerns involving chemicals already in the food supply. The process is intended to move FDA beyond a primarily reactive model and toward a more standardized process for deciding which chemicals warrant full scientific assessment.
Key components of the process include:
- Signal Detection. FDA will monitor and identify signals, meaning data or information, suggesting a potential hazard, change in use or change in exposure related to a food chemical. Sources may include scientific literature, regulatory developments, stakeholder submissions and other publicly available information. FDA also indicates that it will use artificial intelligence tools, including the Warp Intelligent Learning Engine (WILEE), to help identify potential chemical safety signals.
- Triage. FDA scientific staff will review identified signals to determine whether the enhanced systematic process is the appropriate assessment pathway. Certain issues will not be prioritized for a scientific assessment as they are handled through alternative mechanisms, including matters with insufficient supporting information, chemicals already undergoing FDA assessment or immediate health risks or compliance matters.
- Prioritization. FDA will use its post-market assessment prioritization tool to rank chemicals for assessment based on potential public health risk. The tool uses a Multi-Criteria Decision Analysis (MCDA) method and focuses on toxicity, changes in exposure, use or presence in foods specifically marketed to or intended for susceptible subpopulations, and new scientific information and its potential impact. Importantly, FDA explicitly noted that the prioritization tool is not a full scientific assessment and is not used to determine the safety of chemicals in food or as a basis for post-market risk management. Rather, the tool is designed to help establish priorities for the annual post-market work plan.
- Annual Work Plan. FDA intends to publish an annual post-market assessment work plan identifying chemicals selected for further scientific assessment. FDA also emphasized that the inclusion of a chemical on the work plan or the List of Select Chemicals Under Review does not mean that the food chemical’s current use in food is unsafe; it only means that FDA is conducting a scientific assessment of the food chemical and its current uses. FDA also removed the earlier distinction between “focused” and “comprehensive” assessments; under the final framework, FDA will use a single scientific assessment pathway, with the scope and scale of the assessment depending on the chemical, available science and conditions of use or presence in food or food contact materials.
- Scientific Assessment. The assessment phase may include initial stakeholder engagement, including RFIs, development of a preliminary scientific assessment, public comment on that preliminary assessment, optional peer review, and publication of a final scientific assessment.
- Risk Management and Action. Following assessment, FDA may determine that no further action is needed or may pursue risk management measures, including amending or revoking existing authorizations for certain uses, issuing alerts or communications, establishing action levels or specified limits for contaminants, taking enforcement or import action, requesting recalls where appropriate or working with industry on voluntary reformulation or phase-out commitments.
Considerations
FDA’s May 2026 announcements mark an important step toward a more modern, systematic and transparent post-market program for chemicals in food. The framework does not mean that FDA will take regulatory action against any particular substance, but it does outline how the agency intends to approach prioritizing food chemical reviews and the framework and tools it will use when doing so. These developments also affirm that food policy continues to be an active area of focus for FDA and the administration.
Companies should treat these developments as an opportunity to review regulatory files, assess chemical portfolios and prepare for potential increased attention from FDA, states, retailers, consumers and advocacy groups. These developments are also likely to be of interest to Congress, especially on the heels of FDA’s Fiscal Year 2027 budget requesting an increase in funding for the foods program with a focus on food chemical safety.
The public comment period for the BHT and ADA RFIs will close on July 13, 2026.
