The presence of the four distinct seasons with appropriate temperature and humidity in Japan surrounded by sea fostered the Japanese food eating habit and created a distinctive Japanese food culture. The term “health foods” (HF) is commonly used in Japan to describe what may be called “functional foods” (FF) or “dietary or food supplements” in the USA and other countries. This chapter serves to enhance understanding of HF in relation to various regulatory systems and safety concerns in consumers. The “Foods with Specified Health Uses” (FOSHU) concept is described as it evolved from FF which was first developed and published for the health benefits of foods in our country in 1984. In 1991, the Ministry of Health and Welfare (MHW), now known as the Ministry of Health, Labor and Welfare (MHLW), officially presented the FOSHU system as a basis for making the functional claims of foods (FD). It was in reference to the increase in the occurrence of lifestyle-related diseases (LSRD) that include diabetes mellitus, high blood pressure, cerebro- and cardiovascular diseases and cancer. In 2001, a new regulatory system, “Foods with Health Claims” (FHC) was established and consisted of a new concept of “Foods with Nutrient Function Claims” (FNFC) and innovated FOSHU. In 2005, the MHLW additionally changed the existing FOSHU system. Such change includes the new subsystems of FOSHU: standardized FOSHU, qualified FOSHU and disease risk reduction claims. Lastly, issues directed to the safety and quality of raw materials and HF products are also discussed with the focus on two guidelines that require good manufacturing practice (GMP) and self-investigating systems for safety of raw materials.