The Study of the Registration Guideline of Nutraceutical Products in Asean Countries

(E-pub Ahead of Print)

Author(s): Sneha Vaghela, Nehal Bhavsar, Mansi Athalye*.

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs

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Over the years, a number of dietary supplements and health foods are being utilized and are available at pharmacy stores. These medicinally or nutritionally functional foods are considered as ‘Nutraceuticals’. The term was defined in 1989 by Stephen De Felice, founder and chairman of the Foundation for Innovation in Medicine, an American organization which encourages medical health research. He defined a nutraceutical as a “food, or parts of a food, that provide medical or health benefits, including the prevention and treatment of disease” [1]. As these substances are neither be considered as drug or as food, the risk of toxicity and safety should be considered for better health management which requires the research and safety evaluation of Nutraceuticals as per the regulations. Therefore, the aim of the present work is to review regulatory prospects of these Nutraceutical products in ASEAN countries.

Keywords: Nutraceutical, ASEAN countries, Registration Guidelines, regulatory scene, revolution

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(E-pub Ahead of Print)
DOI: 10.2174/2213476X06666190916121705