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." The current Japanese system for regulation of health foods, designated FHC, consists of 2 categories; FNFC and FOSHU. The label FNFC may be freely used if a product satisfies the standard for the minimum and maximum levels per daily portion consumed. FOSHU are those that contain dietary ingredients that have beneficial effects on the physiological functions of the human body, to maintain and promote health and improve health-related conditions. Health claims on FOSHU correspond to other function claims of the Codex Alimentarius or structure/function health claim in the United States. However, "reduction of disease-risk" claims are not allowed, except for calcium and folic acid. In terms of approval, the Food Safety Commission examines the safety of the product, and the Pharmaceutical Affairs and Food Sanitation Council evaluates its effectiveness. Subsequently, the MHLW individually approves claims, which allows the manufacturer to officially carry the claim and special FOSHU logotype on their product. To make the system beneficial for consumers, training for experts who are able to educate, teach, and counsel about "health foods" is extremely important. To maintain and improve the health status of people and to prevent chronic noncommunicable diseases, Japanese authorities recommend a diet balanced with staple foods, such as steamed rice, fish, meat, chicken, eggs, and tofu, and side dishes including vegetables as key dietary elements. Healthy individuals should obtain all necessary energy, nutrients, and nonnutritious components from regular meals. They should never take "quasidrugs" containing vitamins and minerals and "health foods" including FHC in place of their daily diet and ordinary meals. |
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