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

This article provides a comparative analysis of the regulatory frameworks governing nutraceuticals—products that include dietary supplements, functional foods, and related health products—in the United States and India. In the US, nutraceuticals are regulated as dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994, with oversight by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), focusing on post-market surveillance, labeling, and health claims without requiring pre-market approval. In contrast, India regulates nutraceuticals as "Foods for Special Dietary Uses" under the Food Safety and Standards Act (FSSA) of 2006, with the Food Safety and Standards Authority of India (FSSAI) overseeing pre-market approvals, licensing, labeling, and stricter compliance standards. The article highlights key differences such as definitions, registration processes, labeling requirements, and permissible health claims, noting challenges including inconsistent international definitions, regulatory gaps, and enforcement disparities. It also discusses emerging trends like personalized nutrition, tighter health claim oversight, and efforts toward global harmonization to facilitate consumer safety and market growth.