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

[ Vol. 7 , Issue. 2 ]


Mansi Athalye *, Sneha Vaghela and Nehal Bhavsar   Pages 104 - 116 ( 13 )


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”. 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.


Nutraceuticals, prevention, regulatory prospects, toxicity, American organization, health benefits.


Pharmaceutics and Pharmaceutical Technology, L.M. College of Pharmacy, Ahmedabad, Department of Pharmaceutics, Indubhai Patel College of Pharmaceutical Education and Research, Anand, Gujarat, Drug Regulatory Affairs, West Coast Pharmaceuticals Ltd. Ahmedabad

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