Management, Safety, and Efficacy Evaluation of Nutraceutical and Functional Food: A Global Perspective

Abstract

Growing health consciousness and aging populations have driven surging demand for traditional and complementary medicines (T&CM), including nutraceuticals, functional foods, and food and medicinal substances (FAMS). Chronic disease burdens and preventive healthcare trends further amplify this growth. However, fragmented regulatory frameworks, inconsistent definitions, and divergent safety evaluation systems across regions hinder global trade and consumer trust. This review compares T&CM governance in China, the United States, the European Union, Japan, South Korea, Australia, India, Russia, African nations, and faith-based Kosher/Halal certification systems, analyzing legislative milestones and risk management models. Key disparities exist in standardization, ingredient approvals, and evidence requirements. While Asia and the West maintain robust regulations, African countries struggle to align traditional practices with modern safety standards. Emerging technologies such as artificial intelligence (AI)-powered quality control, multi-omics-based validation, and blockchain traceability are critical for ensuring the safety and efficacy of T&CM. The analysis underscores the urgent need for an internationally harmonized regulatory framework, supported by strategic positive/negative ingredient lists and cross-border cooperation. Policy recommendations emphasize integrating traditional knowledge with scientific validation to optimize market accessibility while ensuring consumer safety. This study's novel contribution lies in its systematic evaluation of T&CM's role in bridging cultural heritage with global public health, offering actionable insights for policymakers to foster equitable trade and innovation in the wellness industry.