Vol. 7, Issue 7 (2018)

Author(s):
Bhawna Verma and Harvinder Popli

Abstract:
Nutraceuticals, defined as any food or part of food which provides health benefits including prevention or treatment of disease, have emerged as a necessity for consumers in developed as well as developing countries. With changing lifestyle and related diseases, functional ingredients such as vitamins, minerals, amino acids, fatty acids and Probiotics, etc. have also become a part of this category. Worldwide regulatory authorities are focusing on the Product Quality and Safety as these products are meant for human consumption. As food products are reaching from one country to another, maintaining safety and quality standards as per various regulatory guidelines set by the respective governments becomes important; which can be a real driver for the industry growth. Foods and food habits in today’s lifestyle have lead to the disturbances in an ideally nutritionally balanced body. Therefore in such state if “food be your medicine” then it would be great to achieve a healthy body and mind. 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. It mainly focuses on the similarities and differences of nutraceuticals regulatory framework and structure in USA and India, with harmonized technical requirement for registration of nutraceutical product in this market. This article is based on the complete legal requirements that are necessary for the countries that want to register a nutraceutical food or drug product.