Enhancing Regulation of Nutraceutical Products in Malaysia: Lessons from Japan

The phenomenal commercial success of many nutraceutical products, dietary and health supplements indicate increasing levels of consumer acceptance to the usage of health supplements in Malaysia. As much as these products are consumed for health purposes, lack of effective control by drug authority leaves much to be desired. Legal issues such as marketing approval, product liability, safety, advertising, trade description (nutrition labelling & health claims) would undoubtedly emerge as direct implications from widespread sales and consumption of such products. Consumers' health and safety are at risk where nutraceuticals can easily penetrate into the market without any need of undergoing clinical studies, as opposed to pharmaceuticals. This article was written based on research that has identified several causal factors to the above-mentioned issues. First, nutraceuticals are loosely classified as in between food and drugs. Due to the loose classification scheme, manufacturers tend to opt that their products be classified as food to escape strict clinical evaluations. This leads to the issue of misleading health claims made on its labels and advertisements. The article examines regulation of nutraceuticals in Malaysia and identifies significant issues therein. Comparative analysis with Japanese nutraceutical regulations was made to learn how Japanese classifies its nutraceuticals under specific categories known as ‘Food for Specified Health Uses (FOSHU)’. Products bearing the FOSHU logo went through strict clinical tests and are allowed to make health claims on their labels – and were proven effective and safe for consumption as claimed. The article made several recommendations for the establishment of a legal framework to regulate nutraceutical products in Malaysia.