FDA Requests Information on Two Food Additives

On May 13, 2026, FDA issued requests for information on two food additives as part of its post-market assessment of chemicals used in food: azodicarbonamide (ADA) and butylated hydroxytoluene (BHT). FDA is seeking information about the current uses and safety of both substances in human food and as food-contact substances.

The requests come amid growing federal and state scrutiny of food additives, including proposals in Congress to require more structured post-market review of chemicals in food and to limit the ability of manufacturers to independently determine that a substance is safe without notifying FDA.

Azodicarbonamide (ADA)

According to FDA, ADA is a food additive used as a whitening agent in cereal flour and as a dough conditioner in breadmaking. ADA is also used in the manufacture of food-contact materials.

FDA requested information on ADA’s current uses and safety data to determine whether ADA remains safe under its current conditions of use in food and as a food-contact substance. FDA is particularly interested in information regarding use levels, dietary exposure, decomposition products, current food-contact uses, and the migration of ADA or its decomposition products from food-contact materials into food.

FDA explained that, while it previously determined authorized uses of ADA to be safe, new information may warrant reconsideration of its regulatory status or safe uses. The comment period for ADA closed on July 13, 2026, and was not extended.

Butylated Hydroxytoluene (BHT)

FDA describes BHT as a food additive used as an antioxidant to prevent the spoilage of fats and oils. Antioxidants are used to preserve food by retarding deterioration, rancidity, or discoloration caused by oxidation.

FDA requested information on BHT’s current uses and safety data for use in food and as a food-contact substance. FDA is particularly interested in information regarding the food categories in which BHT is used, typical and maximum use levels, dietary exposure, current food-contact uses, and the migration of BHT from food-contact materials into food.

Although the comment period for the BHT request also closed on July 13, FDA has now reopened the comment period for an additional 30 days in response to a request from stakeholders for additional time. According to FDA, stakeholders needed additional time to develop complete and scientifically robust submissions, particularly because of the need for supply-chain communications.

FDA intends to use the information received through these requests, along with other available information, to inform its post-market safety assessments of ADA and BHT.

Broader Context

FDA’s requests for information on ADA and BHT come as federal and state policymakers are considering broader changes to the way food substances are evaluated and reassessed after entering the market.

As discussed in a previous post, several bills pending in Congress would require FDA to conduct more structured post-market review of food substances. For example, some proposals would require FDA to reassess a minimum number of substances every three years, while another would create an interagency board to reassess older manufacturer determinations.

Congress has also introduced legislation to limit self-affirmed “generally recognized as safe” (GRAS) determinations. Under these determinations, manufacturers can conclude on their own that a substance is safe without notifying FDA or undergoing premarket review.

State legislators in Pennsylvania, New Jersey, New York, and California have similarly introduced legislation to require manufacturers of self-affirmed GRAS to report information supporting the determination to the state. In addition, FDA is expected to propose a rule addressing these determinations.