Is Red Dye 40 banned?

Why Red Dye 40 is flagged

Red Dye 40 has been linked to several health concerns, particularly in children. The most documented association is with hyperactivity and ADHD-related behavior. A landmark 2007 study in The Lancet (McCann et al.) found that a mixture of six artificial dyes including Red 40, combined with sodium benzoate, significantly increased hyperactivity scores in children ages 3 and 8–9. This prompted EFSA to require the 'may have adverse effect on activity and attention in children' warning label across the EU and UK. A 2012 meta-analysis in Neurotherapeutics (Arnold et al.) confirmed a small but statistically significant deleterious effect of artificial food colors on children's behavior, even in those without diagnosed ADHD. The authors described the effect as a public health issue rather than merely an ADHD issue. Regarding carcinogenicity: commercial batches of Red 40 contain trace amounts of benzidine, an IARC Group 1 human carcinogen. A 1994 study in Food and Chemical Toxicology documented benzidine contamination. The FDA maintains that exposure is below harmful thresholds, but the Center for Science in the Public Interest (CSPI) has cited this contamination in multiple ban petitions. Allergic reactions are documented: Red 40 can trigger histamine release leading to hives, rhinitis, and in rare cases anaphylaxis. Cross-reactivity with aspirin is established in aspirin-sensitive individuals. Gut health: A 2021 study in Nature Communications (Kwon et al.) found Red 40 may worsen inflammatory bowel disease and induce colitis-like symptoms in genetically susceptible mice by triggering immune responses in gut-associated lymphoid tissue. In April 2025, HHS Secretary RFK Jr. announced the FDA would phase out Red 40 and 7 other petroleum-based dyes from the US food supply.