FDA could revoke authorization for Orange B color additive in food | Image credit: Contemporary Pediatrics

The FDA is proposing to revoke the regulatory authorization for the use of Orange B as a color additive in food as part of its initiative to phase out petroleum-based dyes, according to a release from the agency.¹

The administration "tentatively concluded that [Orange B's] use has been abandoned by industry and that the color additive regulation is outdated and unnecessary.

The move aligns with other moves from the agency to phase out unnecessary dyes from foods. Recently, the FDA posted a tracker for voluntary industry commitments to remove petroleum-based food dyes in products sold in schools by the start of the 2026 school year and more broadly by 2027.

The agency began this process by banning red no. 3 in food and ingested drugs, with an announcement on January 15, 2025. Manufacturers who use FD&C red no. 3 in food and ingested drugs have until January 15, 2027, and January 18, 2029, respectively, to reformulate products.²

Previous FDA measures related to food dyes

"FD&C Red No. 3 has been primarily used in certain food products, such as candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs," stated the FDA in the announcement at the time.

Then, on April 22, 2025, the agency announced larger steps and outlined more ways to phase out the synthetic dyes from the United States' food supply, which featured 6 steps to be implemented, including the proposed revocation of the Orange B authorization.³

The steps included:

• Establishing a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives.
• Initiating the process to revoke authorization for 2 synthetic food colorings—Citrus Red No. 2 and Orange B—within the coming months.
• Working with industry to eliminate 6 remaining synthetic dyes—FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2—from the food supply by the end of next year.
• Authorizing 4 new natural color additives in the coming weeks, while also accelerating the review and approval of others.
• Partnering with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.
• Requesting food companies to remove FD&C red No. 3 sooner than the 2027-2028 deadline previously required.

The FDA is accepting public comments for 30 days, and all comments must be submitted by October 16, 2025. "After reviewing public comments, the agency will determine whether to finalize this action," the FDA stated in the press release.¹

Click here for more details regarding the banning of FD&C red No. 3, as well as a further discussion via video interview with Amie Alan, RPh, PharmD, PhD, associate professor, Department of Pharmacology and Toxicology, Michigan State University.⁴

Below, click through the slideshow for brief reactions from members of the Contemporary Pediatrics editorial advisory board, including Donna Hallas, PhD, PPCNP-BC, CPNP, PMHS, FAANP, FAAN; and Bernard Cohen, MD.

Hallas is a clinical professor, program director of Pediatrics NP at New York University Rory Meyers College of Nursing in New York, New York.

Cohen is a professor of pediatrics and dermatology at Johns Hopkins University School of Medicine in Baltimore, Maryland.

References:

1. FDA proposes revocation of authorization for Orange B in food. FDA. Press release. September 17, 2025. Accessed September 17, 2025. https://www.fda.gov/food/hfp-constituent-updates/fda-proposes-revocation-authorization-orange-b-food?utm_medium=email&utm_source=govdelivery
2. Fitch J. FDA bans red no. 3 in food and ingested drugs. Contemporary Pediatrics. January 15, 2025. Accessed September 17, 2025. https://www.contemporarypediatrics.com/view/fda-bans-red-no-3-in-food-and-ingested-drugs
3. Fitch J. FDA announces measures to phase out petroleum-based food dyes. Contemporary Pediatrics. April 24, 2025. Accessed September 17, 2025. https://www.contemporarypediatrics.com/view/fda-announces-measures-to-out-petroleum-based-food-dyes
4. Fitch J. Quick reactions to the FDA ban of FD&C red No. 3. Contemporary Pediatrics. January 16, 2025. Accessed September 17, 2025. https://www.contemporarypediatrics.com/view/quick-reactions-to-the-fda-ban-of-fd-c-red-no-3?slide=4