Health Claim Evidence Requirements in Japan

Abstract

In the early 1980s the Japanese scientific academy defined a functional food as a food having a tertiary or physiologically active function. The current Japanese "Food with Health Claims" include 2 categories. For the first category, "Food with Nutrient Function Claims," the label may be freely used if a product satisfies the standard for the minimum and maximum levels per daily portion usually consumed. The second category is defined as "Food for Specified Health Uses" (FOSHU). FOSHU foods are those that contain dietary ingredients that have beneficial effects on the physiological functions of the human body, maintain and promote health, and improve health-related conditions. Health claims on these foods correspond to the category of "other" function claims of the Codex Alimentarius. However, claims of disease-risk reduction are not currently allowed under FOSHU with an exception for calcium and folic acid. Manufacturers can emphasize the characteristics of their products and promote sales by labeling or claims. Therefore, the labeling should be clear and correct and avoid any chance of misinterpretation. The labeling of health claims on foods should always be based on scientific evidence. Any manufacturer who applies to the government for approval under the FOSHU code for its product must tabulate both published available publications and internal reports on the effectiveness of the product and/or its ingredients and provide a summary of each available publication or report. The tabulation must include in vitro metabolic and biochemical studies, in vivo studies, and randomized controlled trials on Japanese people. The overall philosophy of the Ministry is to maintain and improve the health status of people and to prevent chronic noncommunicable diseases through an approach that involves a well-balanced diet as well as through the use of "health foods" including "Food with Health Claims."

Inhibitory Effects of Eight Green Tea Catechins on Cytochrome P450 1A2, 2C9, 2D6, and 3A4 Activities

“…It has been reported that catechins reduce body fat and weight (12)(13)(14)(15). On the basis of these reports, green tea beverages containing catechins, such as EGCG, were approved as Food for Specified Health Uses (FOSHU) (16) by the Consumer Affairs Agency of Japan, and were recommended for reducing body fat. As a result, people who drink these beverages in large quantities will be ingesting catechins in amounts never ingested before.…”

Use of Dietary Supplements among Preschool Children in Japan

“…The Japanese government regulates supplements and functional foods in two categories ( 3 ). One is Food for Specified Health Uses (FOSHU), and the other is Food with Nutrient Function Claims (FNFC), which contains vitamins and minerals that have accumulating scientific evidence for their safety and efficacy as in the Dietary Reference Intakes ( 4 ), and corresponds to dietary supplements in the United States.…”

Gazing into the crystal ball: future considerations for ensuring sustained growth of the functional food and nutraceutical marketplace

“…Enacted in 1991, Japan's regulations under Food for Specified Health Uses (FOSHU) is considered among the most advanced, with eight categories of health claims (18) . As of 2007, 755 items had been approved for FOSHU status (18) (19) and the European Commission has authorised the use of seven disease reduction health claims (20) . In the USA, the Food and Drug Administration (FDA) has authorised twelve health claims under the Nutrition Education Labeling Act (NELA).…”