Health claims on foods should always be substantiated scientifically. The Japanese Ministry established a regulatory system of “Foods for Specified Health Use (FOSHU)” in 1991. The health claims of FOSHU are evaluated individually by experts committee in the government based on the scientific substantiation. The substantiation of health claims in the FOSHU approval system should be based on human intervention studies in addition to in vivo animal and in vitro studies with statistical analysis. FOSHU products increased the total to about 950 items in April 2011. Another health claims system in Japan is “Food with Nutrient Function Claim”. The Japanese Ministry standardised the health claims, the upper limits and the lower limits, and the warning labeling concerning 12 vitamins and 5 minerals. Nutrient function claims, the other function claims and the disease risk reduction claims were proposed by the Codex and EU regulation defined the function claim, the children's health claims and disease risk reduction claims. There is similarity among the structure/function claims in the Dietary Supplement Health Education Act in the US, function claims in EU and FOSHU claims. Nutrient function claims based on well-established knowledge could be standardised and innovative claims should be evaluated individually by independent experts in order to protect consumers from false or misleading descriptions.