Health foods and foods with health claims in Japan.

The terms 'nutraceuticals' and 'dietary or food supplements' are not very popular in Japan as compared to most of other countries. However, the concept of 'functional foods', which benefits the structure and function of the human body, is known as a result of research studies initiated on the health benefits of foods in 1984. The Ministry of Education organized a national research and development project to evaluate the functionalities of various foods. Researchers from diverse scientific fields succeeded to define new functions of food, successfully incorporating the previously recognized functions of nutrition, sensory/satisfaction and physiological effects of ingredients in foods. Some of the food manufacturers and distributors unfortunately capitalized on such food functionalities to promote 'health foods' by claiming drug-like effects and violating laws. In 1991, the Ministry of Health and Welfare (MHW) now as the Ministry of Health, Labor and Welfare (MHLW) introduced a 'foods for specified health uses' (FOSHU) system, for the control of such exaggerated and misleading claims. The other reason for such enforcement is due to an increase in the population of elderly people and lifestyle-related diseases that include obesity, diabetes mellitus, high blood pressure, cerebro- and cardiovascular diseases and cancer. In 2001, a new regulatory system, 'foods with health claims' (FHC) with a 'foods with nutrient function claims' (FNFC) system and newly established FOSHU was introduced. In addition, MHLW has changed the existing FOSHU, FNFC and other systems in 2005. Such changes include the new subsystems of FOSHU such as (1) standardized FOSHU, (2) qualified FOSHU and (3) disease risk reduction claims for FOSHU. In the present chapter, two guidelines that require good manufacturing practice (GMP) and self-investigative systems for ensuring the safety of raw materials used for products in the dosage forms such as capsules, tablets, etc. have been discussed. Furthermore, issues related to positioning and definition of supplements are also discussed in the light of the enhancement of understanding the beneficial roles that supplements may play for human health in Japan.