FDA Expands Post-Market Review of Food Chemical Safety

The U.S. Food and Drug Administration has taken several significant steps this month to expand and formalize its post-market review of food chemicals already in commerce. On May 12, 2026, FDA finalized a systematic post-market review process shaped by stakeholder input, released for comment a draft prioritization scheme for reviewing existing chemicals, and updated its list of chemicals under review, including butylated hydroxytoluene (BHT) and azodicarbonamide (ADA). On May 27, FDA further advanced those efforts by releasing a scientific evaluation of certain phthalates authorized for use in food-contact materials as part of a potential future cumulative risk assessment.

Taken together, these actions reflect a more systematic and data-driven FDA approach to post-market oversight and align with broader MAHA-related regulatory initiatives to increase scrutiny of long-used food ingredients and food-contact materials.

Key Takeaways

• FDA has formalized a systematic post-market review process that includes signal detection, triage, and prioritization.
• FDA will annually announce a “post-market work plan” listing the food chemicals the agency has selected for scientific assessments. The agency also plans to regularly update List of Select Chemicals in the Food Supply Under FDA Review to track ongoing assessments.
• FDA will conduct scientific assessments on select chemicals—with each assessment commencing with an initial opportunity for stakeholder engagement, including issuance of a data call.
• FDA has initiated reassessments of BHT and ADA. FDA’s data requests for BHT and ADA close on July 13, 2026.
• FDA has advanced its review of certain phthalates used in food-contact materials. FDA released a scientific evaluation supporting grouping four phthalates (DEHP, DCHP, DIOP, and DINP) as chemically or pharmacologically related substances for purposes of a future cumulative risk assessment and upcoming post-market safety assessment of phthalate food-contact uses.
• Selection for review is not itself a safety determination. Nevertheless, FDA review activity may prompt customer inquiries, retailer pressure, state-level activity, reformulation requests, or litigation interest even before FDA reaches a final conclusion.

How Will FDA’s New Post-Market Assessment Program Work?

FDA’s new Post-Market Assessment Program is intended to provide a structured and transparent process for reassessing the safety of food chemicals already in commerce. FDA’s Human Foods Program, through the Office of Post-Market Assessment, will lead implementation.

• Signal Detection and Triage
  
  FDA will monitor for “signals” that may warrant reassessment of a food chemical’s safety, including new hazard information, changes in use or exposure, contamination concerns, or other developments that could affect risk. FDA will then triage those signals to determine whether they should proceed through the Post-Market Assessment Program, be addressed through another FDA process, or require immediate assessment, such as in cases involving potential carcinogenicity. FDA also has indicated that it plans to solicit public nominations of food chemicals for future assessment.
• Prioritization and Annual Work Plans
  
  Prioritization: FDA will use its revised Post-Market Assessment Prioritization Tool to determine which chemicals move forward for scientific assessment. Experts from FDA’s Human Foods Program will score chemicals using public-health criteria, including toxicity, changes in exposure, use in foods consumed by susceptible populations, and new scientific information that could affect prior safety conclusions. Unlike earlier versions of the tool, the revised framework does not incorporate stakeholder concern raised by governmental or non-governmental groups into the prioritization process.
• Scientific Assessments and Risk Management
  
  FDA will conduct scientific assessments of chemicals selected for review. Assessments will begin with stakeholder engagement, including issuance of a “data call” requesting public input on the chemical’s use and safety. FDA will then publish a preliminary scientific assessment for public comment and, in some cases, peer review before issuing a final scientific assessment.

Practical Considerations

Companies should consider the following steps:

• Review product portfolios and prioritization risk. Identify food additives, GRAS substances, color additives, food-contact substances, processing aids, and contaminants that may be associated with emerging toxicology signals, increased exposure, use in foods consumed by susceptible populations, or recent international regulatory activity.
• Prepare core data in advance. FDA’s anticipated 60-day comment periods may leave limited time to gather use-level data, exposure information, toxicology support, supplier records, and confidential business information justifications. Companies that cannot substantiate actual conditions of use and exposure may face increased regulatory, commercial, and litigation risk as FDA expands post‑market review activity.
• Evaluate supply-chain and regulatory response readiness. Companies should consider whether existing agreements and internal processes adequately address reformulation, alternative sourcing, customer notification, specification changes, regulatory developments, and coordinated engagement through trade associations where appropriate.
• Risk management actions. After completing a scientific assessment, FDA will decide whether additional measures are needed to address any identified risks. Potential actions may include restricting authorized uses, working with industry on voluntary phase-outs or recalls, or setting action levels or contaminant limits.

Looking Ahead

The BHT and ADA reassessments will provide an early indication of how FDA intends to implement its new post-market review framework in practice, including how the agency evaluates industry-submitted data and approaches potential risk-management actions. Companies using food chemicals likely to attract future FDA attention should consider preparing now rather than waiting for a docket to open. More broadly, FDA’s recent actions suggest that post-market reassessment activity may become a more regular and visible component of the agency’s food chemical oversight program.

MoFo’s Food Regulatory team is well positioned to assist companies in evaluating potential reassessment risk, preparing for FDA data calls and scientific assessments, developing exposure and safety support, and managing related regulatory, commercial, and litigation considerations as FDA expands its post-market review activities.

If you have any questions concerning the developments discussed in this client alert, please contact the authors.