A Short Review on a Comparative Study of Regulation of Nutraceuticals in USA and India

Author(s)

Patel, H., Shah, D., Maheshwari, D.

Author's Affiliation

Abstract

Nutraceuticals are the combination of Nutrition and pharmaceuticals. Every Country has their own guideline and a regulatory requirement which deals with registration process of nutraceuticals. A dietary supplement is a product taken by mouth that contains a dietary ingredient (Vitamins, Minerals, Herbs, Amino acids etc.) Numerous definitions and nomenclature for dietary supplements exist worldwide. This article provides a short review of the Nutraceuticals regulation set out by US Food & Drug administration in USA and in India by Food Safety Standard Authority of India. Mainly focuses on the similarities and differences of nutraceuticals regulatory framework and structure in USA and India, with stress on global harmonization and harmonized technical requirement for registration of nutraceutical product in this market. A comparative approach was used in this study. The study of the differences and similarities could serve as a measure to find methods for global harmonization, which is currently a vital necessity for regulation. The study is based on the complete legal requirements that are necessary for the countries that want to register a nutraceutical food or drug product.

Keywords

Nutraceuticals, Regulation of Nutraceuticals, Labelling and Health Claims

Cite This Article

Patel, H., Shah, D., & Maheshwari, D. (2014). A Short Review on a Comparative Study of Regulation of Nutraceuticals in USA and India. International Journal for Pharmaceutical Research Scholars (IJPRS), 3(1), 736-741.