It is 18 years since the regulatory system of health food, the Foods for Specified Health Uses (FOSHU) came into force in Japan in 1991. However, the comprehensive law specifying and defining ‘supplements' has not yet been established, except for FOSHU, which is only the system permitting health claims for ‘supplements', whereas the United States (US), European Union (EU), and several other Asian countries such as Korea and China have enacted laws specifically regulating supplements. In this paper, recent trends of the development of FOSHU in Japan and some of the key issues of the FOSHU system are discussed.

Outline of FOSHU System

Functional claims for both foods and food ingredients are permitted for Food for Special Dietary Uses (FSDU) and the Foods with Health Claims (FHC) according to the Health Promotion Law in Japan. FSDU, for which a preceding regulatory system was introduced in 1952, is a system with allowed claims, which was established in 1973 to regulate foods especially necessary for persons who are positioned in particular categories such as patients, infants, pregnant women, nursing mothers, etc. FOSHU was at first established as a part of FSDU. While FSDU is for patients and other people who fall into the particular categories, FOSHU is for the foods intended to be used by healthy people with the aim of keeping and promoting health based on the function of respective food ingredients.

Initially one of the important requirements for the approval of FOSHU was the product form, which was taken as conventional foods and not in the form of tablets and capsules. On the other hand, the form of tablets and capsules has been an essential criterion for defining dietary and food supplements in the US and EU respectively. Concomitantly, the health claims have been permitted for such supplements both in the US and EU. In Japan, the establishment of a law specifically for supplements was discussed extensively. Through the discussion, the Ministry of Health, Labour and Welfare (MHLW) decided in 2001 to permit the adoption of shapes of tablets and capsules as FOSHU products. Simultaneously, the MHLW also decided to introduce another regulatory system for the new category of foods, known as Foods with Nutrient Function Claims (FNFC), which was composed of 12 vitamins and five minerals as nutrients and which was permitted to claim particular nutrient functions determined by the MHLW.

Then, the new regulatory category of foods, called Foods with Health Claims (FHC) consisting of FOSHU and FNFC, was established by the MHLW. The positioning of FOSHU is illustrated in figure 1.

Requirements for the Approval of FOSHU

The approval of FOSHU is given to a finished product but not to a food ingredient. To acquire FOSHU approval, data regarding efficacy and safety of the product and the crucial ingredient of the product related to the claim for health-related uses are required to be submitted. After evaluation of the data from point of view of scientific evidence, the health-related claim is determined by the MHLW. The essential requirements for acquiring the approval of FOSHU products are listed in table 1.

The assessment of the safety of a product is carried out by the Food Safety Committee which is the organisation for the risk assessment of foods and is established by the Cabinet Office, while the efficacy of the product is evaluated by the special committee established by the MHLW. Finally, the product is examined by the Pharmaceutical Affairs and Food Sanitation Council of the MHLW in accordance with the assessment of safety and efficacy, and the Minister of Health, Labour and Welfare grants an approval to the product.

Various data and documents including a randomised placebo controlled clinical trial (RCT) are necessary for obtaining a FOSHU approval and selling such FOSHU products. Thus, it takes a long period of time and requires a huge amount of developmental cost to launch FOSHU products into the marketplace and consequently, products approved as FOSHU did not exceed 500 in the first 13 years following establishment of the system. In 2005, the MHLW introduced two subcategories into the framework of the previous FOSHU system, that is, Qualified FOSHU and Standardised FOSHU, for the relaxation of the requirements of the FOSHU system. The purpose of introducing the subcategories is to make it easier for applicants to obtain approvals. In addition, the disease risk reduction claims were simultaneously permitted for the existing FOSHU products (but not for the Qualified and Standardized FOSHUs) under limited conditions. The disease risk reduction claims are currently limited to calcium for the reduction of risk of osteoporosis and folic acid for the prevention of the risk of neural tube defect. The daily intakes of calcium and folic acid must be in the ranges of 300 to 700 mg and 400 to 1,000 μg, respectively, as conditions for the permission.