• On May 12, 2026, FDA announced that the Agency finalized its new “proactive food chemical safety post-market assessment program” and launched reassessments of butylated hydroxytoluene (BHT) and azodicarbonamide (ADA).
  • FDA released two documents to guide the post-market assessment program. The document “Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food” describes how FDA  will “identify food chemicals for review, prioritize identified food chemicals for assessment, structure scientific assessments, and communicate risk management plans.” The document describes “chemicals in food” to include “any substance found in or added to food, including nutrients, food additives, contaminants, and natural ingredients.”
  • The document “Post-Market Assessment Prioritization Tool” is intended to help “identify priority food chemicals for full scientific assessment by focusing on potential risk to public health.” The document covers decisional criteria, including toxicity, change in exposure, use or presence in food for susceptible subpopulations, and new scientific information and potential impact.
  • BHT and ADA have been common targets in recent state legislation, as well as listed priorities in FDA’s post-market review agendas, as we have previously blogged. BHT is used to prevent spoilage of fats and oils, and ADA is used as a whitening agent in cereal flour and as a dough conditioner in breadmaking.
  • Keller and Heckman will continue to monitor FDA’s post-market assessment activities.