FDA today revealed its new program for reviewing the safety of food chemicals in products already on store shelves and is beginning its post-market assessment with two controversial chemical additives: the butylated hydroxytoluene (BHT) and azodicarbonamide (ADA).
The preservative BHT and the synthetic dough conditioner ADA, which also is a bleaching agent used in baked goods, are low-hanging fruit for FDA’s new review program, as both have faced substantial scrutiny in the market for their potential hazards to consumers.
“Americans want the FDA to take a fresh look at some of the chemical additives that have become widespread in our food supply,” said former FDA Commissioner Marty Makary, who separately announced the same day his resignation from the position. “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.”
On the chopping block for decades
Food experts were quick to respond to FDA’s announcement on Tuesday, noting that BHT and ADA are obvious choices for public scrutiny.
For example, ADA was banned in the EU in 2005 and the American Bakers Association announced in February that 95% of its members already do not use the ingredient and the remainder have voluntarily committed to phase it out as part of ABA’s Baked Goods Ingredient Pledge.
The Institute of Food Technologists said it will engage with its members to review the FDA announcement “and to focus our response and commentary going forward.”
“Having food science at the center of decision making will help ensure that the health and well-being of the American consumer will be supported and fostered,” the group added.
It previously lauded the strengthening of FDA’s post-market assessment framework, calling in February for five priorities:
- Anchor prioritization in scientific evidence
- Increase transparency in signal monitoring and horizon scanning
- Establish a defined pathway for public input
- Clarify prioritization criteria, timelines, and resource allocation
- Engage the food science community through structured consultation.
Meanwhile, nonprofit organization Environmental Working Group (EWG) noted that it has long advocated for more restrictions on BHT and ADA, including both chemicals in its “dirty dozen” chemicals to avoid.
“There is already adequate information for the FDA to take action on these harmful chemicals and several states have already proposed restricting them in food, especially school food. Given what we know, the FDA should act swiftly to regulate,” said Melanie Benesh, EWG vice president for government affairs.
New post-assessment process
FDA will use its “Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food” document and its Post-Market Assessment Prioritization Tool to guide the reviews.
The post-market assessment document lays out how FDA plans to monitor and organize information on food chemical safety.
“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,” FDA said.
Benesh criticized the assessment document and prioritization tool, noting that “both documents are thin on details and fail to provide timelines or other metrics for quickly and thoroughly assessing the safety of food chemicals.”
“Neither document mentions that ‘reasonable certainty of no harm’ is the legal safety standard for food chemicals,” she said.
The administration also is calling for public comment on BHT and ADA by July 13, 2026. Updates on the assessments are available on the web at FDA’s List of Select Chemicals in the Food Supply Under FDA Review.
The Post-Market Assessment Prioritization Tool aims to help identify food chemicals that are a priority for safety assessment. The streamlined criteria for decision making aims to increase focus on public health outcomes, FDA said.
“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 US food supply remain safe as new scientific information becomes available,” said Kyle Diamantas, former FDA deputy commissioner for Food, who will succeed Makary in an acting capacity. “This systematic, transparent approach helps protect public health and reinforces the rigorous safety standards that protect American consumers.”
Food chemicals on the chopping block
The announcement follows similar efforts by FDA to review the safety of butylated hydroxyanisole (BHA), a synthetic antioxidant used to preserve fats and oils.
FDA issued a request for information in February on BHA’s use and safety, with comments due in mid-April. Health and Human Services Secretary Robert F Kennedy, Jr, has strongly criticized BHA.
“BHA has remained in the food supply for decades despite being identified by the National Toxicology Program as ‘reasonably anticipated to be a human carcinogen’ based on animal studies,” Kennedy said in February. “This reassessment marks the end of the ‘trust us’ era of food safety.”
