Chapter 16 - Health Foods and Foods with Health Claims in Japan

Abstract

The term ‘health foods’(HF) is commonly used to describe what may be called ‘functional foods’ (FF) or dietary or food supplements’ in the USA or other countries. This chapter serves to enhance understanding of HF in relation to various regulatory systems and safety concerns in consumers. The ‘Foods for 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 Japan 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 ‘food’ (FD) with reference to the increase in the occurrence of lifestyle-related disease (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 MHWL additionally changed the existing FOSHU system. Such change includes the new subsystems of FOSHU: (1) standardized FOSH, (2) qualified FOSHU and (3) FOSHU with disease risk reduction claims. Also, issues directed to the safety and quality of raw materials and HF products are discussed with the focus of two guidelines that require good manufacturing practice (GMP) and self-investigating systems for safety of raw materials. On September 1, 2009, the Consumer Affairs Agency (CAA) was emerged and its roles are added in this edition.