FDA to reassess ADA and BHT May 22

The U.S. Food and Drug Administration said on May 12 that it had begun new safety reassessments of butylated hydroxytoluene, or BHT, and azodicarbonamide, or ADA, while finalizing a broader post-market program for reviewing chemicals already used in food. The move did not ban either ingredient. Instead, the agency opened two requests for information seeking updated data on current uses, exposure and safety as part of what it described as a more systematic review process. Food Dive reported on May 21 that the FDA was also backing away from an earlier plan that would have prioritized ingredient reviews based mainly on consumer concern. In the FDA’s account of the final framework, the agency said it revised its ranking method after public comment and external scientific peer review to focus more directly on public health outcomes and to clarify how the prioritization tool fits into the wider review process. (fda.gov) ### What exactly did the FDA announce? The FDA said the May 12 announcement had two parts: a finalized “proactive food chemical safety post-market assessment program” and the launch of reassessments for BHT and ADA. The agency said two documents will guide its annual assessment plan, including an “Enhanced Systematic Process” for monitoring and triaging safety signals and a “Post-Market Assessment Prioritization Tool” for deciding which chemicals warrant full scientific review. (fooddive.com) Kyle Diamantas, the FDA’s deputy commissioner for food, said in the agency release that the framework was intended to give the public confidence that chemicals in the U.S. food supply remain safe as new scientific information emerges. Marty Makary, who was FDA commissioner at the time of the announcement, said Americans wanted the agency to “take a fresh look” at additives that had become widespread in the food supply. (fda.gov) ### Where are BHT and ADA used? Food Dive said BHT is used as a preservative in frozen meals, breakfast cereals, chewing gum and meat products. The trade publication said ADA is used as a dough conditioner in breadmaking and as a whitening agent in cereal flour, and noted that it is sometimes labeled the “yoga mat” chemical because of its use in foamed plastics outside food. (fda.gov) The FDA’s Federal Register notices said the reassessments cover BHT and ADA in human food and as food contact substances. The agency said it was seeking information on uses, use levels, dietary exposure and safety data for both chemicals. ### Why is the agency asking for information instead of issuing a ruling? (fooddive.com) The Federal Register notices published on May 13 said the FDA was requesting information because, while it had previously concluded authorized uses were safe, new information could require reconsideration of a substance’s regulatory status or safe uses in food. The notices describe the current step as information-gathering within a post-market assessment, not a final determination. (federalregister.gov) The FDA said food manufacturers, researchers and consumers could all submit relevant material to the two dockets. The agency also said information from manufacturers on actual uses and use levels was important for the assessment. ### What changed in the FDA’s review approach? The FDA said it modified its previously proposed ranking method after public comment and outside peer review. (regulations.justia.com) The final version, the agency said, streamlined scoring and decisional criteria, increased clarity about the role of the prioritization tool, and focused the assessment process on public health outcomes. (govinfo.gov) Food Dive characterized that change as a step away from prioritizing reviews mainly around consumer concern. That matters because the draft approach the FDA floated in 2024 had drawn attention for explicitly weighing public concern in how chemicals might be ranked for review. ### What happens next, and when? The FDA said the public comment period for both requests for information closes on July 13, 2026. (fda.gov) The BHT docket is listed as FDA-2026-N-2526, and the ADA docket is listed as FDA-2026-N-4126 in the Federal Register notices. After that date, the agency has said it will review the submitted information as part of its post-market assessments of the two chemicals. (fooddive.com) The FDA did not give a date for final conclusions on BHT or ADA in its May 12 announcement. (fda.gov) (regulations.gov)