 FDA Finalizes Food Chemical Safety Post-Market Assessment Program, Launches Reassessment of BHT, ADA
View on the FDA Website
May 12, 2026
The U.S. Food and Drug Administration today continued to implement its bold food agenda, with two decisive actions focused on food chemical safety. First, the agency finalized its new proactive food chemical safety post-market assessment program.
Second, the FDA launched reassessments of butylated hydroxytoluene (BHT) and azodicarbonamide (ADA), chemical additives commonly used in a variety of food products. As part of this reassessment, the agency issued two requests for information (RFI) regarding the use and safety of these chemicals in food.
"Americans want the FDA to take a fresh look at some of the chemical additives that have become widespread in our food supply," said FDA Commissioner Marty Makary, M.D., M.P.H. "By establishing a comprehensive, science-based framework for reviewing chemicals like BHT and ADA, we're delivering the rigorous oversight Americans deserve. We will act swiftly based on our findings."
Two documents will guide the FDA’s annual food chemical post-market assessment plan. The first, “Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food,” describes how the FDA will monitor and triage signals that provide information on hazards, use, or exposure related to food chemicals, then prioritize for assessment, evaluate, and manage these chemicals in the food supply. Based on public feedback, the agency streamlined this process, incorporated additional public engagement opportunities, and provided additional details regarding how it will receive and identify potential safety signals, triage signals to determine how they should be handled, and how scientific assessments will be communicated to the public.
The second document, “Post-Market Assessment Prioritization Tool,” helps identify priority food chemicals for full scientific assessment by focusing on potential risk to public health. Based on public comment and external scientific peer review, the FDA made modifications to the agency’s previously proposed method for ranking chemicals for assessment, including streamlining decisional criteria and scoring to focus on public health outcomes and increasing clarity on how the prioritization tool fits into the FDA's overall systematic process.
"Today’s release finalizes our framework for this new, dedicated reassessment program that provides Americans with confidence that the FDA is ensuring chemicals in the U.S. food supply remain safe as new scientific information becomes available," said Kyle Diamantas, J.D., Deputy Commissioner for Food. "This systematic, transparent approach helps protect public health and reinforces the rigorous safety standards that protect American consumers."
BHT is used to prevent spoilage of fats and oils and can be found in various food products including breakfast cereals, frozen pizza, frozen meals, baking mixes, cookies, chewing gum, and meat products. ADA is used as a whitening agent in cereal flour and as a dough conditioner in breadmaking and has applications in manufacturing food contact materials.
The agency will continue to provide regular updates on the progress of ongoing assessments through the FDA's List of Select Chemicals in the Food Supply Under FDA Review.
The public comment period for the BHT and ADA RFIs will close on July 13, 2026. The FDA encourages food manufacturers, researchers, and consumers to submit relevant data and information. Full details of the requested data are available in the RFIs for BHT and ADA, and both framework documents are published on the FDA's new post-market safety of chemicals in food webpage.
An unofficial translation of this announcement is provided below.
翻译参考：
FDA 完成食品化学物质上市后安全评估计划，并启动对 BHT 和 ADA 的重新评估
查看FDA网站
2026年5月12日
美国食品药品管理局（FDA）继续推进其食品领域重点议程，围绕食品化学物质安全采取了两项关键行动。首先，FDA正式完成了一项新的、主动性的食品化学物质上市后安全评估计划。
其次，FDA启动了对丁基羟基甲苯（BHT）和偶氮二甲酰胺（ADA）的重新评估。这两种化学添加剂广泛用于多种食品产品。作为评估的一部分，FDA发布了两份信息征集请求（RFI），征集有关这些化学物质在食品中使用情况及其安全性的数据。
FDA局长 Marty Makary博士表示：“美国公众希望FDA重新审视一些已在食品供应中广泛使用的化学添加剂。通过建立一套全面的、以科学为基础的框架来审查BHT和ADA等化学物质，我们正在提供公众所期望的严格监管。我们将根据评估结果迅速采取行动。”
两份文件将用于指导FDA制定年度食品化学物质上市后评估计划。第一份文件《食品中化学物质上市后评估的强化系统流程》描述了FDA如何监测和筛选与食品化学物质的危害、使用或暴露相关的“信号”，并据此确定优先评估对象，开展评估及进行风险管理。根据公众反馈，FDA对该流程进行了优化，包括简化步骤、增加公众参与机会，并进一步明确如何接收和识别潜在安全信号、如何进行分级处理，以及如何向公众传达科学评估结果。
第二份文件《上市后评估优先排序工具》用于识别需要开展全面科学评估的重点食品化学物质，重点关注对公共健康的潜在风险。根据公众意见和外部科学同行评审，FDA对此前提出的排序方法进行了修改，包括简化决策标准和评分体系，更加聚焦公众健康结果，并提升该工具在FDA整体评估体系流程中的定位清晰度。
FDA食品事务副局长 Kyle Diamantas博士表示：“今天发布的内容最终确立了这一全新的专项再评估框架，使公众相信FDA正在随着新的科学信息出现，持续确保美国食品供应中的化学物质安全。这一系统化、透明的方法有助于保护公众健康，并强化保障美国消费者的严格安全标准。”
BHT用于防止脂肪和油脂腐败变质，常见于多种食品，包括早餐谷物、冷冻披萨、冷冻食品、烘焙预混粉、饼干、口香糖及肉类制品等。 ADA用于谷物面粉漂白以及面包制作中的面团调节剂，也用于食品接触材料的生产。
FDA将通过“食品供应中正在审查的重点化学物质清单”持续发布相关评估进展。
针对BHT和ADA的RFI将于2026年7月13日截止。FDA鼓励食品生产企业、研究人员及消费者提交相关数据和信息。有关具体数据要求的详细信息可在BHT 和ADA相关的RFI文件中查阅，两份框架文件也已发布在FDA全新的食品化学物质上市后安全专题网页上。
Sincerely,
Sarah McMullen
Country Director
FDA China Office
Office of Global Operations
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