Quick reactions to the FDA ban of FD&C red No. 3

Quick reactions to the FDA banning of FD&C red No. 3 | Image Credit: © John Doe - © John Doe - stock.adobe.com.

On January 15, 2025, the FDA revoked the authorization of red no. 3 in food and ingested drugs, to be implemented January 15, 2027 and January 18, 2028, respectively.¹

The pull of authorization followed a 2022 color additive petition that cited various data including 2 studies that demonstrated cancer in laboratory male rats that were exposed to high levels of FD&C red no. 3.¹

The FDA noted the way the dye causes cancer in male rats does not occur in humans, and that claims that the "use of red no. 3 in food and ingested drugs puts people at risk are not supported by the available scientific information," wrote the agency.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.^1,2

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

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

References:

1. Fitch, J. FDA bans red no. 3 in food and ingested drugs. Contemporary Pediatrics. January 15, 2025. Accessed January 16, 2025. https://www.contemporarypediatrics.com/view/fda-bans-red-no-3-in-food-and-ingested-drugs

2. Fitch, J. Potential impacts red dye No. 3 has on children. Contemporary Pediatrics. May 2, 2023. Accessed January 16, 2024. https://www.contemporarypediatrics.com/view/potential-impacts-red-dye-no-3-has-on-children

3. How safe are color additives? FDA. Updated July 13, 2023. Accessed January 16, 2024. https://www.fda.gov/consumers/consumer-updates/how-safe-are-color-additives