| Abstract: |
The global nutraceutical industry, valued at approximately USD 451.8 billion in 2024, operates under divergent regulatory architectures that impose fundamentally different clinical evidence standards across jurisdictions. This study presents an evidence-based comparative analysis of nutraceutical clinical validation frameworks in India (FSSAI), the United States (FDA/DSHEA), and the European Union (EFSA/Directive 2002/46/EC), with particular emphasis on safety substantiation requirements, health claim authorization pathways, and pre-market clinical evidence obligations. The primary hypothesis states that significant regulatory asymmetry in clinical evidence requirements among the three jurisdictions creates unequal market entry barriers, consumer safety risks, and structural impediments to global harmonization. Using documentary analysis, regulatory database review, and structured comparative tabulation of official regulatory instruments, this study examined clinical evidence tiers, claim categories, and enforcement mechanisms across the three regulatory regions. |
