FDA Takes Key Steps to Advance Post-Market Safety Assessments of Food Chemicals

Yesterday, FDA announced several actions that will advance its efforts to perform post-market safety assessments of certain substances in the food supply. These include:

• Finalization of FDA’s Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food (Post-Market Assessment Program), which outlines the steps FDA will take to identify, prioritize, and reassess the safety of food chemicals,[1] along with the regulatory actions FDA will take to manage risks identified through those assessments;
• Issuance of FDA’s revised Post-Market Assessment Prioritization Tool, which specifies how FDA will prioritize food chemicals for review under the Post-Market Assessment Program; and
• Publication of requests for information on butylated hydroxytoluene (BHT) and azodicarbonamide (ADA), which will inform FDA’s reassessment of those chemicals under the Post-Market Assessment Program.

These actions provide helpful insight on how FDA will conduct post-market food chemical safety assessments in the coming years, and they mark significant next steps in the agency’s broader efforts to evaluate the safety of substances in the food supply.

Post-Market Assessment Program and Revised Prioritization Tool

FDA’s Post-Market Assessment Program provides a step-by-step overview of how FDA will conduct post-market safety assessments for food chemicals. This process involves:

1. Signal Detection and Triage: FDA will monitor for “signals” indicating a potential need to reassess the safety of a food chemical. These signals include, among other items, data on potential food chemical hazards, changes to a chemical’s intended use that could increase exposure levels, and changes to a chemical that could increase the likelihood of adulteration. FDA will then triage these signals by screening out those that are not appropriate for review under the Post-Market Assessment Program (e.g., because FDA is assessing them through other processes or because they raise issues that require immediate assessment, such as evidence of potential carcinogenicity). FDA has indicated that, in the future, it will also solicit public nominations of food chemicals for assessment, and that details on that nominations process are forthcoming.
2. Prioritization: FDA will use its revised Post-Market Assessment Prioritization Tool to prioritize chemicals for review. Using this tool, experts from FDA’s Human Foods Program will score chemicals using a set of “public health criteria.” These criteria account for the chemical’s toxicity, changes to exposure levels, use in foods for susceptible populations, and the impact of any new scientific information. While prior versions of the prioritization tool would have required that chemicals be scored on additional criteria, including the degree to which governmental and non-governmental stakeholders have raised concerns about a chemical, the revised prioritization tool provides that chemicals will be scored only on these public health criteria. FDA will use this score to determine which chemicals to prioritize for review.
3. Annual Work Plans: Each year, FDA will announce a “post-market work plan” listing the food chemicals it has selected for scientific assessments. FDA will also regularly update its List of Select Chemicals in the Food Supply Under FDA Review to reflect the current status of its ongoing assessments.
4. Scientific Assessments: FDA will conduct scientific assessments on the chemicals it has selected for review. While the exact methods of these assessments will vary on a case-by-case basis, each assessment will begin with an initial opportunity for stakeholder engagement, including issuance of a “data call” through which FDA will request public input on the use and safety of the chemical. FDA will then publish a preliminary scientific assessment, which will be subject to an additional public comment period and, in some cases, a peer review process. After reviewing this input, FDA will publish a final scientific assessment.
5. Risk Management Actions: Finally, FDA will determine whether it needs to take regulatory action to manage any risks identified through its final scientific assessment. This could include, for example, revoking or amending authorizations for certain uses of a food chemical, asking industry to enter into voluntary market-phase out agreements or initiate voluntary recalls, or developing action levels or specified limits for contaminants.

Reassessments of BHT and ADA

FDA also announced that it plans to reassess the safety of BHT and ADA under the Post-Market Assessment Program. To initiate these assessments, FDA published requests for information (RFIs) seeking information on the current uses, use levels, dietary exposure levels, market share of foods formulated with either chemical, documentation of GRAS conclusions or prior sanctions, and other relevant safety data. Stakeholders have until July 13, 2026, to submit responses to these RFIs, after which point FDA will prepare its initial scientific assessments. This follows FDA’s February 11, 2026, RFI on the safety of butylated hydroxyanisole (BHA), which the agency is also reviewing under the Post-Market Assessment Program.

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