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BHT and ADA under FDA reassessment

Bread on a production line
BY: Annie Hollon

Annie Hollon

SILVER SPRING, MD — When the FDA first announced its reassessment of butylated hydroxyanisole (BHA) in February, Commissioner Marty Makary noted that the agency would conduct further assessments into other similar ingredients.

That time has arrived, according to a recent press release from the government agency. The FDA announced two requests for information (RFIs) for the reassessment of butylated hydroxytoluene (BHT) and azodicarbonamide (ADA). Similar to BHA, the former is used to prevent the spoilage of fats and oils in various food products, including cookies. The latter’s applications include being used as a dough conditioner in breadmaking operations.

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“Americans want the FDA to take a fresh look at some of the chemical additives that have become widespread in our food supply,” Makary said. “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.”

The comment period for the BHT and ADA RFIs is open now through July 13.

The agency announced two requests for information to reassess butylated hydroxytoluene and azodicarbonamide, used in various applications, including baking.

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In tandem with this announcement, the FDA also finalized its new proactive food chemical safety post-market assessment program. This move is guided by two documents: “Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food” and “Post-Market Assessment Prioritization Tool.”

The first document outlines how the agency will monitor signals that offer information on hazards, use or exposure tied to food chemicals. This will help the FDA prioritize assessment, evaluation and management of these items. Public feedback has also helped the organization streamline the process.

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The second document, based on public comment eternal scientific peer review, serves as a resource for the FDA to identify priority food chemicals for full assessment. In the revised version, the FDA has modified the previously proposed method for ranking chemicals for assessment. The changes include streamlined decision criteria and scoring to concentrate further on public health outcomes and further clarify how the tool falls into the agency’s 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 US food supply remain safe as new scientific information becomes available,” said Kyle Diamantas, Deputy Commissioner for food. “This systematic, transparent approach helps protect public health and reinforces the rigorous safety standards that protect American consumers.”

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