FDA Initiates Priority Safety Review of BHA Used in Foods

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Image Courtesy: US Food and Drug Administration/Fickr

The FDA has launched a comprehensive reassessment of the food preservative BHA, reviewing its safety under modern scientific standards and potential risks, particularly for children.

Written By: Pharmacally Medical News Desk

The U.S. Food and Drug Administration has launched a comprehensive re-assessment of butylated hydroxyanisole (BHA), a synthetic preservative used to prevent spoilage in foods containing fats and oils. The review will evaluate whether BHA remains safe under its current conditions of use in food and as a food contact substance, using the latest scientific evidence.

As part of this effort, the FDA has issued a formal Request for Information seeking updated data on BHA’s use, exposure, and safety. The move places BHA among the agency’s top priorities under its strengthened post-market chemical review program, introduced in May 2025 to proactively reassess additives already present in the food supply.

Why BHA Is Under the Microscope

BHA has been part of the U.S. food system for decades. It was listed as Generally Recognized as Safe in 1958 and approved as a food additive in 1961. Today, it can still be found in products such as frozen meals, breakfast cereals, cookies, candy, ice cream, and certain meat products.

However, concerns around its long-term safety have persisted. The National Toxicology Program, part of the National Institutes of Health, has classified BHA as “reasonably anticipated to be a human carcinogen” based on animal studies. While food label data suggest that BHA use has declined in recent years, it remains present in many packaged foods, including products marketed to children.

A Shift Toward Stricter Food Chemical Oversight

Health and Human Services Secretary Robert F. Kennedy Jr. said, “This reassessment marks the end of the ‘trust us’ era in food safety.” He noted that chemicals allowed decades ago must now meet modern scientific standards, adding that additives failing to do so could be removed from the food supply, particularly where children face higher exposure.

FDA Commissioner Marty Makary echoed this position, stating that the agency is responding to growing scientific concerns about certain food chemicals. He confirmed that once the BHA review is completed, the FDA expects to conduct similar assessments of butylated hydroxytoluene (BHT) and azodicarbonamide, another controversial food additive.

Kyle Diamantas, Deputy Commissioner for Human Foods, emphasized that the BHA review is part of a more systematic, science-driven approach to food safety, with ongoing evaluations designed to keep pace with emerging evidence.

Broader Reform of the GRAS System

The reassessment of BHA also aligns with wider regulatory reforms. The Make America Healthy Again Commission’s Strategy Report has identified post-market reviews of chemical additives as a key priority. In parallel, the FDA has advanced draft rulemaking to reform its GRAS framework, aiming to improve transparency, address independent GRAS determinations, and strengthen federal oversight of chemicals added to food.

What Comes Next

The FDA’s review of BHA is one of several ongoing post-market assessments under its enhanced chemical evaluation process. Depending on the findings, the outcome could range from continued approval under revised conditions to tighter restrictions or removal from the food supply.

For now, the agency is gathering data and public input, signaling a more assertive stance on legacy food additives and a renewed focus on aligning food safety decisions with current scientific standards.

Reference

FDA Launches Assessment of BHA, a Common Food Chemical Preservative, 10 February 2026, https://www.fda.gov/news-events/press-announcements/fda-launches-assessment-bha-common-food-chemical-preservative

List of Select Chemicals in the Food Supply Under FDA Review, 10 February 2026, https://www.fda.gov/food/food-chemical-safety/list-select-chemicals-food-supply-under-fda-review


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