A Risk-Governance and Exposure-Monitoring Framework for Synthetic Food Dyes in Pediatric Diets in the United States: Decision Indicators, Labeling Salience, and Post-Market Surveillance

Abstract

Purpose: Synthetic food dyes remain pervasive in the U.S. processed-food supply, with exposure concentrated among children and shaped by product formulation, purchasing patterns, and labeling practices. While clinical and toxicological literature increasingly emphasizes heterogeneous susceptibility, regulatory decision-making still faces operational challenges: translating complex evidence into proportionate, implementable risk-management actions. This study proposes a regulatory-science framework that integrates exposure monitoring, decision indicators, and post-market surveillance to strengthen governance for pediatric-relevant dye exposure. Methodology: A conceptual framework was developed using a structured narrative synthesis of (i) clinical evidence on neurobehavioral sensitivity in subgroups, (ii) mechanistic/toxicological plausibility (including oxidative stress and inflammatory signaling), and (iii) regulatory documentation and exposure-context materials from major authorities. The framework was built through an iterative design-science logic: identification of governance gaps; definition of decision indicators; specification of operational levers (benchmark reassessment, labeling as risk communication, surveillance triggers); and articulation of an implementation pathway suitable for routine oversight. Findings: The proposed framework addresses three recurring governance gaps: (1) limited integration of contemporary pediatric exposure patterns into decision thresholds; (2) insufficient operational treatment of heterogeneity and susceptible subgroups; and (3) underutilization of labeling salience and surveillance loops as low-burden risk-management tools. The framework provides a practical approach for tiering exposure contexts, specifying triggers for reassessment, and strengthening post-market monitoring without requiring categorical hazard assumptions. Practical Implications: A proportionate governance model can reduce preventable risk in high-exposure pediatric contexts by improving transparency, enabling caregiver-level exposure management, and supporting periodic reassessment anchored in real-world consumption. The framework is designed to be implementable through existing regulatory infrastructure and adaptable to evolving evidence. Originality: This paper contributes a decision-oriented, implementable governance framework that translates multidisciplinary evidence into operational oversight mechanisms, emphasizing pediatric exposure concentration, susceptibility, and surveillance-driven iteration.