ABSTRACT

The term Nutraceuticals is derived by the combination of nutrition and pharmaceutical. Now-a-days these Nutraceuticals play a major role in the world to enhance the health conditions of humans. Nutraceuticals means food or part of food which increases the health conditions by preventing the diseases. At present the society facing many health problems due to nutritional imbalance. As a result, if “food is your medicine” in such a situation, it would be ideal to obtain a healthy body and mind. For each country there is set of different guidelines and regulatory registration process for nutraceuticals. This article gives a brief overview of the nutraceuticals regulations. In US the nutraceuticals are regulated by Dietary Supplement Health and Education Act of 1994 (DSHEA) under United State Food and Drug Administration. In India the nutraceuticals are regulated by Food Safety Standard Authority of India. The emphasis is on global harmonisation and harmonized technical requirements for registration of nutraceutical products in this market, with a focus on similarities and variations in nutraceuticals regulatory framework and structure in the United States and India. The main aim to introduce the regulatory authority for nutraceuticals is to improve the product quality and safety of nutraceutical products during human consumption. The study of variances and similarities might be used to develop ways to achieve worldwide harmonisation, which is now a critical regulatory need and it is based on all of the legal requirements. Keywords: Nutraceuticals, Regulatory Authority, Regulatory approval process, dietary supplements, health claims
Publication date: 01/02/2023

https://ijbpas.com/pdf/2023/February/MS_IJBPAS_2023_6876.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.2.6876