Title:The Study of the Registration Guideline of Nutraceutical Products in ASEAN Countries
VOLUME: 7 ISSUE: 2
Author(s):Mansi Athalye *, Sneha Vaghela and Nehal Bhavsar
Affiliation: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
Keywords:Nutraceuticals, prevention, regulatory prospects, toxicity, American organization, health benefits.
Abstract: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.
