FDA Requests Information on BHA to Support Safety Assessment

On February 10, 2026, the U.S. Food and Drug Administration (FDA) announced the launch of a comprehensive reassessment of butylated hydroxyanisole (BHA), an ingredient typically used in food as an antioxidant to prevent the spoilage of fats and oils.¹ The reassessment will consider whether BHA is safe under its current conditions of use in food and as a food contact substance based on current scientific data. Along with this announcement, FDA issued a request for information (RFI) on the current uses of BHA in human food and as a food contact substance as well as any related safety data.² This review is part of FDA's broader effort to review chemical additives in the food supply on a proactive basis as a part of the agency's Post-Market Chemical Assessment Program, which was referenced in the Make America Healthy Again Commission's Strategy Report.

Background

BHA was listed as generally recognized as safe (GRAS) in 1958 and was approved as a food additive in 1961. BHA acts as an antioxidant and is used to prevent the spoilage of oils and fats in frozen meals, breakfast cereals, ice cream, and meat products, among others. Currently, BHA is authorized for use in food and as a food contact substance through multiple different pathways, including:

• GRAS for use as an antioxidant in food generally with limitations;³
• Prior-sanctioned use as a food contact substance with limitations;⁴
• Direct food additive use as an antioxidant alone or with butylated hydroxytoluene (BHT) in certain foods, flavoring substances, and chewing gum with specified limitations;⁵
• Indirect or secondary direct food additive use as an antioxidant in food contact surfaces including defoaming agents, adhesives, semirigid and rigid acrylic and modified acrylic plastics, closures with sealing gaskets for food containers, ethylene-vinyl acetate copolymers, machinery lubricants with incidental food contact, and polyethylene film; and
• Ingredient use in the FDA and USDA standard of identity for margarine⁶ and the USDA specification for butteroil.⁷

In 1990, FDA received a Food Additive Petition calling for the prohibition of BHA in certain uses, which has remained open. According to FDA communications regarding this review, potential safety concerns regarding the use of BHA have been raised for decades and the National Institute of Health’s National Toxicology Program lists BHA as “reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity from studies in experimental animals.”⁸

Under the Biden Administration, FDA took several steps to create a more systematic process for post-market assessments of food additives, as well as substances that are GRAS, color additives, food contact substances, and unintentional contaminants. In August 2024, FDA released for public comment a discussion paper outlining its plan for an enhanced systematic process for post-market assessment of chemicals in food. During the Trump Administration, Secretary Kennedy has prioritized greater scrutiny of food additives and the post-market reassessment of chemicals in the food supply was included in the Make America Healthy Again Commission’s Strategy Report. Further, food chemical safety was listed as the top priority in FDA’s list of 2026 Priority Deliverables, which specifically noted FDA would be assessing the safety of phthalates, propylparaben, BHA, and BHT in 2026.⁹

Request for Information

FDA’s RFI is focused on uses, use levels, dietary exposure, and safety data on BHA currently used in food and as a food contact substance, including:

1. The general food categories in which BHA is used;
2. Typical and maximum levels of BHA in each food category;
3. Data on the migration of BHA from food contact materials into food in current uses;
4. Subpopulations with high dietary exposure to BHA or other relevant safety concerns;
5. Other dietary sources of BHA (i.e., dietary supplements, natural occurrence, contaminants in water, etc.);
6. Market share of foods and food contact substances using BHA;
7. Biomonitoring data for BHA or its metabolites;
8. Market disappearance or poundage data;
9. Information on chemically or pharmacologically related substances;
10. Safety data on the use of BHA;
11. Documentation of GRAS conclusions or prior sanctioned uses for BHA (other than those cited in the “background” section above); and
12. Information supporting the conclusion BHA is no longer used for one or more of its authorized or intended uses.

Comments on the RFI are due April 13, 2026.

Next Steps

We will continue to monitor FDA’s work as part of its Post-Market Chemical Assessment Program.

References

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

2 91 Fed. Reg. 6227 (Feb. 11, 2026).

3 21 C.F.R. § 182.3169.

4 21 C.F.R. § 181.24.

5 21 C.F.R. §§ 172.110, 172.515(d), and 172.615(a).

6 21 C.F.R. § 166.110(b)(5) and 9 C.F.R. § 319.700(b)(6).

7 7 C.F.R. § 58.305(b).

8 Report on Carcinogens: Butylated Hydroxyanisole, NIH NTP (accessed Feb. 10, 2026), available at: https://ntp.niehs.nih.gov/sites/default/files/ntp/roc/content/profiles/butylatedhydroxyanisole.pdf.

9 Human Foods Program 2026 Priority Deliverables, FDA (Jan. 27, 2026), available at: https://www.fda.gov/about-fda/human-foods-program/human-foods-program-2026-priority-deliverables.

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