FDA Finalizes Food Chemical Safety Post-Market Assessment Program, Launches Reassessment of BHT, ADA

The U.S. Food and Drug Administration (FDA) finalized a new food chemical safety post-market assessment program May 12 and launched reassessments of butylated hydroxytoluene (BHT) and azodicarbonamide (ADA), chemical additives commonly used in food products.

As part of the reassessment, the agency issued two requests for information regarding the use and safety of these chemicals in food.

FDA said two documents will guide the agency’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 said it has streamlined this process, incorporated additional public engagement opportunities and provided more 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,” is designed to help 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, the agency 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 U.S. food supply remain safe as new scientific information becomes available," said FDA Acting Commissioner of Food and Drugs Kyle Diamantas. "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 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 said it will 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. 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.