Regulation of Functional Foods in Japan

In the 1980s, the Japanese government funded large-scale research programs for systemic analysis of food functions and the physiological regulation of the function of food and the molecular design of functional foods. In 1991, the government established the Japanese Foods for Specified Health Use (FOSHU) to define foods with potential health benefits to help stem the rising cost of health care in Japan.

Under the FOSHU system, health claims are approved for specific products. Companies make an application for FOSHU approval to the Ministry of Health and Welfare (MHW). FOSHU are those foods that have a specific health benefit due to the presence of certain constituents or foods. Allergens cannot be present. Scientific substantiation, including the scientific evidence of safety and efficacy of the food and the medical or nutritional basis for the claim, must be provided to the MHW for consideration. To be classified as FOSHU, it must be demonstrated that the final food product, not just individual components, is likely to have a beneficial health effect when consumed as part of the normal diet. FOSHU must be in the form of food and not pills or capsules.

The labeling of FOSHU foods must not be misleading and must include the approved health claim, the recommended daily intake, relevant nutrition information, guidance on healthful eating, and any necessary warnings regarding excessive intake. Domestic products have an 'approved' mark from the MHW, whereas imported products have a ''permitted'' mark.

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