Navigating nutraceuticals regulation: A comparative assessment of the USA and India

Abstract

The market for nutraceuticals, including dietary supplements, functional foods, and pharmaceuticals, has seen unprecedented expansion globally as consumers increasingly become interested in health and wellness products. Global harmonization is, however, hindered by the huge differences in the regimes of regulation that encompass such products. The main distinctions, regulatory gaps, and compliance issues between the nutraceutical laws in the US and India are highlighted in this review’s comparative analysis. As dietary supplements, nutraceuticals are primarily regulated in the US by the Dietary Supplement Health and Education Act (DSHEA) of 1994. The Federal Trade Commission (FTC) and the U.S. Food and Drug Administration (FDA) oversee pre-market and post-market rules, including labeling and advertising claims. In contrast, the Food Safety and Standards Authority of India (FSSAI) oversees nutraceuticals in India in compliance with the Food Safety and Standards Act (FSSA), 2006; specific guidelines for nutraceutical products and health supplements were published in 2022. Important regulatory issues are highlighted in this research, including varying pre-market approval procedures, conflicting definitions, and different quality requirements. It also discusses the intricacies of health claims and labelling regulations, highlighting the necessity of strict post-market monitoring to guarantee consumer safety. The relevance of regulatory adaptation to innovation is emphasized by the paper’s exploration of worldwide market trends, which include the growth of natural components and individualized nutrition. This study intends to shed light on the difficulties experienced by industry participants and the prospects for international regulatory harmonization by analysing the regulatory frameworks in both nations, opening the door to a more unified global nutraceutical market.