In Japan the market of dietary supplements is quite different from USA and EU countries. In April 2001 the "nutritionally functional foods" system was introduced by the Ministry of Health, Welfare and Labor. However, this system is limited to just 12 vitamins and two kinds of minerals. Only nutritional claims of these nutrients are indicated on the label along with their contents. Upper limit contents of these vitamins and minerals are the same as those of quasi-drugs containing vitamins and minerals, and lower than those of over the counter drugs. The lowest contents of vitamins and minerals in these Products were defined to be one third of recommended dietary intake levels for adults. Major problems of this system are the limitation to only 12 vitamins without vitamin K and two minerals and the fact that the permitted ingredients must be food additives. Another problem is reference as to prevention of diseases caused by life style cannot be permitted. As this system has only started, future reexamination of this system will be necessary based on the comment of experts.

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The United States was the first country in the world to permit legally the sale of dietary supplements. The law that permits the use of dietary supplements for promoting the health of people is known as the "Dietary Supplement, Health and Education Act of 1994", abbreviated as DSHEA. DSHEA is characterized by its claim, "Statements of Nutrition Support", and permit to state the efficacy on the structure and function of human. Due to the effectuation of the DSHEA, research on the efficacy of dietary supplements including various vitamins on the health Promotion and prevention of diseases has been greatly stimulated in the United States. Also, vitamins have become more widely used by people for protecting themselves from diseases to maintain good health. The new division responsible for the encouragement of research on dietary supplements is the Office of Dietary Supplements (ODS), situated at the National Institutes of Health (NIH). Under these circumstances, dietary suDDlements have become a timely topic for discussion internationally as to whether dietary suDolements are really reauired for the health and eeneral welfare of human beings. A oossible conclusion seems hopeful.

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While the sales of dietary supplement products have been rapidly increasing, some consumers use such supplements wrongly, in fact. For safety of consumers, it is essential to educate medical care providers and supplement sales staff because they should play an important role to provide consumers with correct information. Otsuka Pharmaceutical Co., Ltd. implemented the "Otsuka Academy Vitamin Program" to provide the latest and most correct information about vitamins and minerals. Fully supported by the UCLA Center for Human Nutrition, the US nutritional education program has been modified to the Japanese version consisting of three seminars (at Tokyo and Osaka) and correspondence education with texts for one year. In the seminars, domestic and foreign researchers and nutritional experts give presentations about various benefits of vitamins and minerals based on the latest data; and in the texts, fundamental information about vitamins and minerals is found. The program participants who obtain sufficient credits can receive a certification issued by the UCLA Center for Human Nutrition and a name badge indicating "Vitamin Adviser". A total of 9,314 of doctors, pharmacists, dietitians, and other medical care providers have participated the program so far. They actually conduct advising and consulting activities about vitamin and mineral for consumers. Otsuka Pharmaceutical also continues to provide the latest and most correct information for them after completion of the program through newsletters and inquiries via facsimile and the Internet. As correct information is vital to select the optimal supplement for each consumer, the education of advisers should greatly contribute to the health care of the consumers.

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At the 16^<th> session of the Codex Committee on Nutrition and Foods for Special Dietary Uses in 1988, the issue of supplementary foods or dietary supplements was raised. In 1995, at its 19^<th> ssession the issue was formally adopted as Proposed Draft Guidelines for Dietary Supplements, and problems to be solved were exoected as a) an acceotable definition of dietary supplements, b) lists of nutrients/ingredients, c) upper limits for single nutrients and their justification and d) regulations for admissible claims. The committee agreed to refer to only"Vitamins and Minerals", as the guidelines would not apply to other nutrients and to advance to"the step at 5"in 1996. Even though once it was agreed to advance to the"step at 5", in 1997 the Commission decided to return to"step 3" for further reconsideration of its fundamental need. In the meantime, the Guidelines for use of Nutrition Claims, in which nutrient function claims had been defined were adopted in 1997. Further, the Proposed Draft Guidelines for Use of Health and Nutrition Claims were advanced to "step at 5" in May 2002. Progress on the discussions on those Guidelines should be closely monitored.

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