Paper Title
Enhancing Regulation on Nutraceuticals in Malaysia: Lessons from Japan

Consumption and wide use of nutraceutical products has gained much popularity in these modern days, mainly attributed to their proclaimed goodness in maintaining health and well-being. The rapid rise of the healthcare cost is also another driving factor which prompts consumers to opt for the concept of preserving good health from food, in alternative to prescribed drugs and modern medicines. In Malaysia, there exists no specific statutory definition of nutraceuticals and hence nutraceutical industry players have the liberty to market them as either food supplements or pharmaceutical products. As most nutraceutical products are not classified as pharmaceutical drugs, they can avoid the stringent regulation of the Drug Control Authority (DCA). Consumers' health and safety are at risk due to the lack of control and supervision of nutraceutical products. These products can easily penetrate into the marketwithout the need of undergoing clinical studies as being imposed on pharmaceutical products.Since registration requirements which are applicable to food supplements are less strict as compared to requirements for pharmaceutical products, manufacturers prefer to classify them under the former and not the latter. Setting on this background, this paper seeks to examine the regulations applicable to nutraceutical in Malaysia, particularly on the loopholes in the current legal framework. The paper then proceeds to discuss on the current regulation of nutraceuticals in Japan, with the primary aim of emulating the most suitable, best practice from the Japanese regulatory system. This paper concludes with some suggestions to be adopted in Malaysia based on Japanese successful experience and systematic ways of regulating its Food for Specified Health Uses (FOSHU) products for the benefit of consumers at large. Keywords - Nutraceutical, Drugs, Regulation, Safety, FOSHU