CLINICAL AND REGULATORY IMPLICATIONS OF ARTIFICIAL FOOD DYES IN THE UNITED STATES: A REGULATORY SCIENCE AND RISK-GOVERNANCE REVIEW

Purpose: Artificial food dyes are widely used in the U.S. processed-food supply, with exposure concentrated inpediatric diets. This review synthesizes clinical, toxicological, and regulatory evidence through a regulatoryscience lens, emphasizing governance gaps, risk communication, and the implications of current oversight forchild health protection.Design/Methodology/Approach: A structured narrative review was conducted using peer-reviewed clinicalstudies, toxicological assessments, exposure-context materials, and regulatory documentation from majorauthorities. Evidence was organized across three domains: (i) neurobehavioral outcomes in children, (ii)mechanistic plausibility (oxidative stress and inflammatory signaling), and (iii) regulatory decision frameworks,including risk-management tools (acceptable daily intake, labeling, and post-market reassessment). Core dyesdiscussed include Red 40 (Allura Red), Yellow 5 (Tartrazine), and Yellow 6 (Sunset Yellow).Findings: The evidence base most consistently supports heterogeneity of response: a subset of children appearsmore vulnerable to dye-associated neurobehavioral effects, particularly in real-world dietary contexts thatinclude multiple additives. Toxicological literature provides plausible pathways—such as oxidative stress andinflammatory activation—that may help explain differential susceptibility. Regulatory practices show persistentmisalignment across jurisdictions, and current U.S. approaches may not fully reflect contemporary exposurepatterns or modern expectations for neurodevelopmental endpoint evaluation.Practical Implications: From a risk-governance perspective, feasible, proportionate measures include updatedtoxicological reassessments, exposure-informed revisions of benchmarks, clearer labeling as riskcommunication, and stronger post-market monitoring—particularly for pediatric-oriented products.Originality/Value: The review integrates multidisciplinary evidence into a decision-relevant synthesis,translating clinical and toxicological findings into implementable reg