International Journal of Science and Research (IJSR)

International Journal of Science and Research (IJSR)
Call for Papers | Fully Refereed | Open Access | Double Blind Peer Reviewed

ISSN: 2319-7064


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Review Papers | Pharmacy | India | Volume 13 Issue 2, February 2024 | Rating: 4.4 / 10


An Exhaustive Review on Regulatory Pathway for the Approval of Nutraceuticals as Per India, USA & Japan

Shrutika Sharma | Dr. Vikesh Kumar Shukla [3]


Abstract: The global nutraceuticals market, which was valued at $413.0 billion in the year 2020, is expected to see a magnanimous growth of about $650.5 billion by the year 2030, with a compound annual growth rate (CAGR) of about 3.9%. The term nutraceuticals have varied definitions; however, it can simply be put as "food or part of a food that provides medical or health benefits." These can further be used to improve health, prevent chronic diseases, increase life expectancy, or aid functions of the body. In general, the goals of nutraceutical regulation are to pay more emphasis on the product claims and intended use which is accomplished through Good Manufacturing Practices. Howbeit, the regulatory structure for nutraceuticals differs across countries and even regions where, USA primarily categorises nutraceuticals as "dietary supplements" under the Dietary Supplement Health and Education Act (DSHEA), Japan regulates nutraceuticals under Food for Specified Heath Uses (FOSHU) and Indian regulations envelop a wide range of nutraceuticals and novel foods under Food Safety and Standards Authority of India (FSSAI). Bringing nutraceuticals for retail usually follows four basic approaches: a pre - market notification, consumer access, safety, and robust post - market surveillance. Hence, due to the emerging economy of nutraceuticals it is essential to form a food - based regulatory paradigm that focuses on the primary aspects of registration and notification - based system for launching new products in the market.


Keywords: Nutraceuticals, Functional Foods, Novel Foods, Product Claim


Edition: Volume 13 Issue 2, February 2024,


Pages: 410 - 416


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