Global regulatory trends and comparative insights: Nutraceuticals in the USA, India, and Europe

IF 2.4 Q3 NUTRITION & DIETETICS PharmaNutrition Pub Date : 2025-01-07 DOI:10.1016/j.phanu.2025.100430

Anushree Bose, Sanjay Sharma

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Abstract

Purpose

This review aims to analyze and compare the regulatory frameworks governing nutraceuticals in the USA, India, and European Union (EU). The primary research question explores how varying regulations impact the global market entry and safety of nutraceutical products, while identifying potential pathways for harmonizing international regulations.

Methods

A comprehensive literature review was conducted, focusing on key regulatory documents and guidelines from the Dietary Supplement Health and Education Act (DSHEA) in the USA, the Food Safety and Standards Authority of India (FSSAI), and the European Food Safety Authority (EFSA). The study examined market entry processes, safety standards, toxicity testing, and health claim requirements across these regions.

Results

The findings indicate significant differences in regulatory approaches. The United States of America (USA) emphasizes post-market surveillance and manufacturer responsibility for product safety, while India follows a simpler registration process. Europe mandates rigorous pre-market approval and scientific validation of health claims. These disparities hinder the seamless integration of nutraceutical products into international markets.

Conclusions

The review highlights the growing need for harmonization of nutraceutical regulations globally. Unified guidelines could improve product safety, facilitate international market entry, and foster greater consumer trust. Regulatory convergence will be essential to ensure the sustainable growth of the nutraceutical industry.

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