FDA Sets Final Food Chemical Review Framework, Starts BHT and ADA Reassessment

The US Food and Drug Administration (FDA) on May 12 said it has finalized a new post-market food chemical safety assessment program and begun reassessing 2 widely used chemical additives for food: butylated hydroxytoluene (BHT) and azodicarbonamide (ADA).¹ For food and nutraceutical manufacturers, the move signals a more structured federal approach to reviewing legacy ingredients already in commerce, with potential implications for reformulation and regulatory monitoring.

The agency paired the framework announcement with 2 requests for information, seeking updated use, exposure, and safety data on both compounds. Public comments for the requests for information are scheduled to close July 13, 2026, with food manufacturers, researchers, and consumers encouraged to submit relevant information. "Americans want the FDA to take a fresh look at some of the chemical additives that have become widespread in our food supply," stated former 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."

BHT is used prevent the spoiling of fats and oils, and can be found in breakfast cereals, frozen meals, baking mixes, chewing gum, and meat products. ADA has been used in flour and breadmaking and in food-contact material manufacturing, according to the agency.

What Does the FDA’s New Post-Market Food Chemical Review Program Change for Manufacturers?

According to the agency, 2 documents will guide its annual post-market assessment plan. One describes an “enhanced systematic process” for identifying and triaging safety signals related to hazard, use, or exposure, followed by prioritization, scientific assessment, and risk management. The other is a prioritization tool designed to rank food chemicals for full review based on potential public health impact.

This matters commercially because many food ingredients remain in use for years after original market entry, while the scientific literature, exposure patterns, and manufacturing practices continue to evolve. Although the announcement is not specific to dietary supplements, it is relevant to manufacturers watching broader food chemical oversight trends, especially where food and supplement supply chains overlap.

The FDA said public feedback led it to revise the framework by streamlining parts of the process, adding public engagement opportunities, and clarifying how signals will be identified, triaged, and communicated. "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," stated 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."

How Does This Fit Into the Broader Food Safety and Regulatory Context?

The agency is seeking current data from manufacturers, researchers, and other stakeholders before completing any reassessment. That process may bring renewed scrutiny to use levels, technical function, exposure estimates, and any newer toxicology findings. The current notice does not itself change the legal status of BHT or ADA, nor does it announce a safety determination. The FDA said it will post updates through its list of select chemicals under review.

What remains unanswered is how quickly the agency will complete the reassessments, what evidentiary thresholds it will apply in any subsequent risk management decision, and whether additional commonly used food chemicals will be queued for review under the same prioritization tool. Those questions will likely determine how consequential the new framework becomes for formulation planning across the food and nutraceutical sectors.

In recent years, outside scrutiny of older additives and calls for more transparent reassessment have increased, particularly where substances were authorized under older evidentiary standards or remain widely consumed across multiple product categories. For example, earlier this year, the agency announced it had initiated a review of the long-established food preservative butylated hydroxyanisole (BHA) to reassess its safety.² The additive had been classified as Generally Recognized as Safe (GRAS) in 1958 and approved as a food additive in 1961.

References

1. US Food and Drug Administration. FDA finalizes food chemical safety post-market assessment program, launches reassessment of BHT, ADA. News release. May 12, 2026. Accessed May 12, 2026. https://www.fda.gov/news-events/press-announcements/fda-finalizes-food-chemical-safety-post-market-assessment-program-launches-reassessment-bht-ada
2. McEvoy E. FDA begins comprehensive review of food preservative BHA. February 10, 2026. Accessed May 14, 2026. https://www.nutritionaloutlook.com/view/fda-begins-comprehensive-review-of-food-preservative-bha