May 18, 2023
The National Center for Health Research (NCHR) appreciates the opportunity to submit our public comment to the Food and Drug Administration (FDA) on the Filing of Color Additive Petition from the Center for Science in the Public Interest.
NCHR is a non-profit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
We support the request that the U.S. Food and Drug Administration (FDA) ban the use of FD&C Red No. 3 in foods, drugs, and dietary supplements. We strongly agree with the decision Congress made in 1960 that cancer-causing color additives have no place in our foods, drugs, supplements, or cosmetics. We find it unacceptable that the FDA has known for more than 30 years that Red 3 can cause cancer and yet still allows the dye to be used in foods, drugs, and supplements.
In 1990, FDA concluded that Red 3 causes cancer when ingested by animals after reviewing studies it received in the early 1980s. From this conclusion, FDA revoked the provisionally allowed uses for Red 3, including use in cosmetics and externally applied drugs. FDA claimed it would separately take steps to revoke the permanently approved uses, namely drugs and foods, including supplements, but never followed through on that plan. FDA estimated in 2016 that 84 percent of the U.S. population two years of age and older was exposed to Red 3. Red 3 is found in thousands of food and drug products currently on the market, including many marketed to children. In fact, American children ages 2 to 5 consume twice as much Red Dye No. 3 as the general population on a body-weight basis.1
Three decades have elapsed, and yet Red 3 remains approved for use in foods, drugs, and supplements. Meanwhile, more recent research has continued to link Red 3 to hyperactivity and other neurobehavioral effects in children.2
A full ban on Red 3 is long overdue. We urge that FDA act quickly and decisively to prohibit all uses of Red 3 to protect consumers, especially children, from this cancer-causing chemical.
1. Doell, D., Folmer, D., Lee, H., Butts, K., & Carberry, S. (2016). Exposure estimate for FD&C colour additives for the US population. Food additives & contaminants. Part A, Chemistry, analysis, control, exposure & risk assessment, 33(5), 782–797.
2. California Office of Environmental Health Hazard Assessment. Report Links Synthetic Food Dyes to Hyperactivity and other Neurobehavioral Effects in Children. https://oehha.ca.gov/risk-assessment/press-release/report-links-synthetic-food-dyes-hyperactivity-and-other