FDA chemical review targets BHT and ADA

The U.S. Food and Drug Administration has finalised its post-market food chemical safety assessment programme and launched reassessments of butylated hydroxytoluene and azodicarbonamide, placing two established food chemicals under renewed regulatory scrutiny.

The programme gives FDA a more structured process for monitoring, triaging, prioritising, assessing, and managing food chemicals after they are already in use. A finalised prioritisation tool will help identify which chemicals should move into full scientific assessment, with public health risk central to the process.

The first reassessments under the finalised framework cover butylated hydroxytoluene, known as BHT, and azodicarbonamide, known as ADA. FDA has issued requests for information on the use and safety of both chemicals, with the public comment period running until 13 July 2026.

BHT is used to help prevent spoilage in fats and oils. It can be found in 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 it also has applications in the manufacture of food-contact materials.

The move shifts food chemical oversight further towards continuing reassessment. Many ingredients, processing aids, additives, and packaging-related chemicals entered use under scientific, manufacturing, and dietary conditions that have changed over time. A formal post-market process gives regulators a clearer route to revisit those substances as exposure data, toxicology, use patterns, and international regulatory positions evolve.

For manufacturers, the immediate effect is a data-gathering and review process rather than a ban. Even so, the operational work begins well before any final regulatory decision. Food businesses using BHT or ADA may need to map where the substances appear, gather supplier data, review technical justifications, and assess possible reformulation routes. Packaging suppliers using ADA in food-contact material applications may face similar documentation and assurance requirements.

The development sits within a wider tightening of food safety and chemical scrutiny. IN Food recently covered A2 Milk’s infant formula recall over toxin risk, where supplier control and contaminant monitoring were central to a sensitive category. FDA’s chemical review concerns a different type of risk, but it reinforces the same operating reality: food safety systems now extend deep into ingredients, processing aids, packaging, supplier documentation, and historical approvals.

ADA cuts across formulation and packaging in a way that manufacturers cannot treat as a single-department question. A substance used in flour treatment and food-contact materials may involve bakery development, ingredient procurement, packaging assurance, and regulatory affairs. That spread makes internal traceability and supplier communication more important as reassessment moves forward.

BHT creates a different challenge because it is used across several processed food categories where fats, oils, and shelf-life protection are important. Replacing or reducing an antioxidant can affect oxidation stability, flavour protection, shelf life, processing conditions, packaging atmosphere, and distribution temperatures. Reformulation may also shift pressure onto packaging if weaker oxidative stability requires stronger barrier performance or tighter storage controls.

The new FDA framework will increase the value of regulatory surveillance. Companies selling into the US will need to monitor reassessment lists and public comment windows with the same discipline applied to allergens, contaminants, labelling, and import requirements. Complex ingredient systems, private-label arrangements, and co-manufacturing models will make that work more demanding.

Food chemical safety is becoming more dynamic. Long-standing use no longer guarantees low-friction approval, and older ingredients may face renewed examination as scientific tools and public expectations change. BHT and ADA are the first tests under FDA’s finalised process, and the way those reassessments progress will indicate how quickly the new system can move from monitoring into practical regulatory pressure.