Health Claim Evidence Requirements in Japan 1,2

Transcription

1 The Journal of Nutrition Evidence for Health Claims on Food: How Much Is Enough? Health Claim Evidence Requirements in Japan 1,2 Kazuhiko Yamada, 3 * Natsuko Sato-Mito, 3 Junichi Nagata, 3 and Keizo Umegaki 4 3 Food Function and Labeling Program and 4 Information Center, National Institute of Health and Nutrition, Tokyo , 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. J. Nutr. 138: 1192S 1198S, Introduction With the rapid increase in the senior population in Japan and the development of a senior society, chronic diseases of aging such as diabetes, cardiovascular disease, hypertension, osteoporosis, and cancer are also on the rise. These diseases are connected not 1 Published in a supplement to The Journal of Nutrition. Presented as part of the Canadian Nutrition Congress held in Winnipeg, Canada, June 18 21, This conference was supported by Nestlé Nutrition; Canadian Egg Marketing Agency; Danone Institute; Dow AgroSciences Canada; Flax Canada 2015; Martek Biosciences Corporation; The Centrum Foundation; Canadian Grain Commission; Dairy Farmers of Canada; Faculty of Agricultural and Food Sciences, and Faculty of Human Ecology, University of Manitoba; Manitoba Science, Technology, Energy and Mines; Mead Johnson Nutritionals; The Manitoba Co-operator; Alltech Canada; Agri-Food Research and Development Initiative (ARDI); Beef Information Centre; Canola Council of Canada; Cognis; Elanco Animal Health; Grainews; Lipid Nutrition; Manitoba Agriculture, Food and Rural Initiatives; Maple Leaf Animal Nutrition; Monsanto Canada; Pfizer Animal Health; Prairie Hog Country; Pulse Canada; Bruker Optics; Bunge Canada; Canbra Foods; Faculty of Graduate Studies, University of Manitoba; Novus International; and POS Pilot Plant Corp. This publication was supported by Danone Institute International and Agriculture and Agri-Food Canada. Supplement Coordinators for this publication were Peter Jones, University of Manitoba, Winnipeg, Canada and Primal Silva, Agriculture and Agri-Food Canada, Ottawa, Canada. Supplement Coordinator disclosure: P. Jones received travel support and has a consulting agreement from Danone Institute International; P. Silva is employed by the supplement sponsor, Agriculture and Agri-Food Canada. 2 Author disclosures: K. Yamada, N. Sato-Mito, J. Nagata, and K. Umegaki, no conflicts of interest. * To whom correspondence should be addressed. peaceboy@nih.go.jp. 1192S only to age but also to lifestyle factors such as diet, nutrition, and physical exercise. The goal of functional foods is to prevent the development of such chronic disease before treatment requiring drugs becomes necessary. In anticipation of the increase in the senior population in Japan, the Japanese Ministry of Education initiated research and development projects concerning the functionalities of food in The projects employed researchers within the disciplines of nutrition, pharmacology, psychology, and the medical sciences. These projects defined a functional food for the first time. Foods in general were defined to have 3 functions. The primary function was identified as nutritional, that is, essential for human survival. The secondary function was identified as sensory, or sensory satisfaction, such as deliciousness, flavor, and good texture. The tertiary function was physiological, such as regulation of biorhythm, the nervous system, the immune system, or body defense. Functional foods were assessed as foods possessing tertiary functions. During its first decade, this project identified many actual chemical components of each specific food that had a tertiary function. The scientific evidence for functional foods is still accumulating as additional studies on the physiological functions of foods are conducted (1). Labeling of functional foods is considered important for both consumers and producers. Through labeling, consumers can understand the features, contents, and usage of the foods and then choose the proper foods for themselves using the informa /08 $8.00 ª 2008 American Society for Nutrition.

2 tion provided on the label. With more public information on health benefits of food than ever before, consumers interest in health issues has become a leading factor in their purchasing decisions. Manufacturers can emphasize the characteristics of their products and thus promote sales by the labeling or claims made. 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. The current Japanese system for regulation of health foods (2) is called Food with Health Claims (FHC) 5 and is made up of 2 categories: 1) Food with Nutrient Function Claims (FNFC) and 2) Food for Specified Health Uses (FOSHU). The first approval system: foods for specified health use The evolving state of food claims prompted the Ministry of Health, Labor and Welfare (MHLW) to establish a regulatory system for such claims, to correctly inform people about health information of foods. Thus, FOSHU was set up by the MHLW in 1991 as a regulatory system to review and approve label statements regarding effects of foods on the human body (3 5). FOSHU was originally enacted under the Nutrition Improvement Law, which is currently termed the Health Promotion Law. This law lists 5 categories of Food for Special Dietary Uses as 1) milk powder for pregnant and lactating women, 2) formulated milk powder for infants, 3) food for elderly people with difficulty in masticating or swallowing, 4) medical foods for patients, and 5) FOSHU. General procedure for approval of FOSHU. Those who wish to apply their products for FOSHU labeling are required to submit the following documentation (6) to the MHLW as indicated in Table 1. Mandated FOSHU documentation can be summarized into 3 essential requirements for FOSHU approval: 1) its effectiveness based on scientific evidence including clinical studies; 2) its safety as assessed from historical consumption pattern data and additional safety studies conducted in humans; and 3) analytical determination of the functional component responsible for the beneficial physiological action. The documentation of effectiveness should be prepared on the basis of substantiation, not only by human clinical and animal studies but also by in vitro metabolism and biochemical data. Such data should demonstrate statistically significant differences between the control and intervention groups. Basically, human studies should be conducted for a reasonably long-term period, e.g.,.1 mo, using the food for which the claim is intended. The study also should be well designed, for example, utilizing an appropriate biomarker and an appropriate sample size, i.e., a sufficient number of subjects to show statistically significant differences. Literature concerning relevant functional constituents, the food carrier, and the related function should be provided in the form of a review. For documentation of safety, both in vivo studies and in vitro studies should be carried out to develop preliminary data to assess the safety of intake in humans. Even if the effective component has been consumed in food by a reasonable number of people over a certain period, safety data regarding human consumption should be provided using at least 3 times the amount of the minimum effective dosage. Literature concerning related 5 Abbreviations used: FHC, Food with Health Claim; FOSHU, Food for Specified Health Uses; FNFC, Food for Nutrient Function Claims; GI, gastrointestinal; MHLW, the Ministry of Health, Labor and Welfare. TABLE 1 Documentation required for application to MHLW for FOSHU status for a product Sample of the entire package with labels and health claims Documentation that demonstrates clinical and nutritional proof for the product and/or its functional component for the maintenance of health Documentation that demonstrates clinical and nutritional proof of the intake amount of the product and/or its functional component Documentation concerning the safety of the product and its functional component, including additional human studies about the eating experience Documentation concerning the stability of the product and its functional component Documentation of the physical and biological characteristics of the product and the functional component Methods of qualitative/quantitative analytical determination of its functional component, and analytical assay results of the component in the product Report on the analysis of the designated nutrient constituents and energy content of the product Statement of the production method, list of factory equipment, and an explanation of the quality control system functional components must be reviewed and provided. If the related literature or report implies an undesirable or adverse effect on health, it should be accompanied by a scientific explanation or a human study that confirms safety in humans. Documentation of the methods for analysis of the functional components should be included in the claim submission. These analytical determinations typically precede clinical studies and animal studies as well as in vitro studies and stability testing. As additional documentation, evidence regarding the stability of related functional components should be provided. If a product is to be administered in the form of tablets or capsules, experiments should be conducted exploring the extent of disintegration or dissolution of the bioactive substance. It is important within the evaluation process that both the benefit and safety of a given functional food differ from those of a medicine. Functional foods are designed to target healthy people or people in a preliminary stage of a disease or a borderline condition of at-risk groups. Therefore, the effectiveness for these people may be reduced compared with medicine for patients. Generally, foods with functionality have been historically consumed by people and thus can be regarded as safer than innovative medicine. The application process for FOSHU starts with the receipt of all the documentation described above by the Office of Health Policy on Newly Developed Foods of the MHLW. The Office assembles an Expert Committee, which consists of 2 subcommittees. One subcommittee evaluates the products on the basis of physiological processes including metabolism and internal secretion, renal function, and blood pressure. The second evaluates those related to gastrointestinal (GI) conditions, the immune system, and miscellaneous functions. During the course of the evaluation, supplemental documentation or amendments may be requested of the applicant by the Office. On receipt, the Office will check the applications and dossiers before they are reviewed by the Pharmaceutical Affairs and Food Sanitation Council and the Food Safety Commission. The examination will be conducted first on the efficacy of the product by the Food Sanitation Committee under the Newly Developed Food Investigation Department and then on the safety of the product by the Food Safety Commission (Fig. 1). After evaluation by the expert committees and the Food Safety Commission, the Council makes the final application to the Council of Pharmaceutical Affairs and Food Hygiene, which makes the final assessment. The Council may ask for additional Health claim evidence in Japan 1193S

3 FIGURE 1 Flow of FOSHU approval. Applicant must pass all 3 processes, A, B, and C. documentation from the applicant if necessary. When the Council determines the application to be appropriate after due discussion, the MHLW notifies the applicant, requesting that the applicant send samples of the product with documentation of the analytical method for the effective component to the National Institute of Health and Nutrition. The Institute then validates the method and determines the content of the effective component. After validation and determination have been completed, the MHLW makes the decision to grant approval for the product under FOSHU. The applicant is then permitted to use the approved health claim on the label, in addition to the FOSHU mark (Fig. 2) on the product, which symbolizes the notion of jumping for health. In the application process, if an effective component of an applying product is the same as an already approved FOSHU product, the procedure of the evaluation for the applying product will likely be shortened. FOSHU application deadlines occur every 3 mo. The applicant should validate the quality, effectiveness, and safety of the product that has been approved as FOSHU using further scientific studies and postmarketing research. Competent authorities from the MHLW can inspect manufacturing plants and evaluate the effectiveness and safety of FOSHU, when necessary, as well as demand additional documentation at any time. Health claims on FOSHU. FOSHU-labeled food (or products) contain health functions that can have positive effects on human physiological function, where it is intended that products be consumed for the maintenance or promotion of health, or special uses by people who wish to control their health conditions. As of December 2007, 755 items had been granted FOSHU status (Fig. 3). The existing health claims on FOSHU can be classified into 8 groups according to the health claims such as GI conditions, mineral absorption, blood pressure, or blood cholesterol. GI conditions. About half of all FOSHU products claim improvement of GI conditions. The effective component is usually a carbohydrate, which can be divided into oligosaccharides, dietary fiber, and lactic acid bacteria. Approved products containing these components can, for instance, claim that they help increase intestinal bifidobacteria and thus help maintain a healthful GI condition. Blood pressure. Effective components including lactotripeptide from fermented milk, dodecapeptide from casein, a group of peptides from sardine, dried bonito, or a kind of seaweed, and g-aminobutyric acid are proposed to reduce blood pressure. Approved products containing these components can claim that they are suitable for people with moderately high blood pressure. Serum cholesterol. Effective components include soy protein, chitosan, low-molecular-weight sodium alginate, and phytosterols. Approved products containing these components can claim that such products help to decrease serum cholesterol levels. Blood glucose. Effective components include indigestible dextrin, wheat albumin, and L-arabinose. Approved products containing these components can claim that these materials are helpful for those who are concerned about their blood glucose level. Absorption of minerals. Fructo-oligosaccharides and casein phosphopeptide are thought to improve calcium absorption within the small intestine. Approved products containing these components can claim improved absorption of calcium. Approved products containing heme iron from hemoglobin can, under FOSHU, claim that this is suitable to control mild irondeficient anemia. FIGURE 2 health. Seal of approval for FOSHU, symbolizing jumping for FIGURE 3 Transition of FOSHU items, as of March 31, Gray bar shows permit number per year, and dotted line shows cumulative permit number. 1194S Supplement

4 Blood neutral fat. Diacylglycerol, eicosapentaenoic acid, docosahexaenoic acid, and digested globin are believed to decrease blood neutral fat levels after meal consumption. Approved products containing these constituents claim that they help to reduce postprandial blood triglyceride levels. Additionally, a product containing diacylglycerol is permitted to claim that this product makes it difficult for fat to cling to the body. Dental health. Some sugar alcohols such as xylitol, maltitol, erythritol, and palatinose are considered to be hypocariogenic, whereas green tea polyphenol is regarded as noncariogenic. Approved products containing these sugar alcohols can claim that these products are low or noncariogenic. Additionally, some FOSHU-approved products can claim that these aid in making strong and healthy teeth. Bone health. Vitamin K-2 and soy isoflavone are regarded as promoters of bone calcification. Approved products containing these components can claim such effects. Health claims on FOSHU must not express medical claims such as prevent, cure, treat, and diagnose. Here are some examples of permitted and nonpermitted claims for human diseases: 1) Maintain or improve a marker determined by selfdiagnosis or health check-up. An example of a permitted claim is This product helps to maintain normal blood pressure, blood sugar, or cholesterol. An example of a nonpermitted claim is This product improves hypertension. 2) Maintain physiological function and organ function of the human body in good condition or improve them. An example of a permitted claim is This product enhances the absorption of calcium or This product helps to improve the movement of the bowel. An example of a nonpermitted claim is This product is an effective food for intoxication or Enhances fat metabolism. 3) Improves the occasional change of body condition but not a chronic change. Permitted claims include This product is good for or helps people who feel fatigue, whereas a nonpermitted claim would include This product helps to slow aging. Food with nutrient function claims The Ministry enacted a new regulation system, FHC in April 2001 (Fig. 4). FHC consists of 2 categories, FOSHU and FNFC. Twelve vitamins including vitamin A, thiamin, riboflavin, B-6, B-12, C, E, and D, biotin, pantothenic acid, folic acid, and niacin as well as calcium and iron have been standardized as FNFC. In 2003, 3 more minerals, zinc, magnesium, and copper were added to FNFC. The minimum daily level per portion for consumption of the products is 30% of the standard values for the nutrition labeling as per the Japanese Dietary Reference Intakes, 2005 edition (7). The maximum level is set as the maximum amount of nutrient items in quasidrugs, such as 25 mg thiamin or 600 mg calcium. Nutrient function claims have been widely accepted by scientific experts, based on scientific evidence, and applied to existing foods or supplements internationally. Such claims are readily understood by the general public (Table 2). Food labels with health claims should meet the following conditions: 1) be consistent with the national nutritional goal and public health policy, 2) prove that the food is useful for supplying nutrition or specified health effect, 3) be based on acceptable scientific data and be a simple as well as an understandable expression, 4) offer appropriate information to the consumer, 5) declare attention and warning, including appropriate intake, to prevent adverse effects on health from overdose, 6) fit under the Food Sanitation Law, Health Promotion Law, and other related laws, and 7) avoid confusion with drugs and not provide labels that imply prevention, treatment, and diagnosis of human disease. Labeling of nutrient function should be based on internationally recognized findings, i.e., examples of nutrient function claims include a reference to the Codex Alimentarius (CAC/GL 23) and should be easy to understand for consumers. Food labels with health claims also require attention and warning of intake ranges consistent with safe consumption. Attention and warning should also be provided on labels for every nutrient including information concerning excess intake of the product. A message giving the recommended consumption should be provided. For instance, for vitamin A, it must be stated that women who are pregnant should be careful of excess intake. Similarly, for folic acid, it should be stated that folic acid is a nutrient that contributes to the normal growth of the fetus but does not improve the growth of fetus with excess intake. Revision of FOSHU categories When the Expert Subcommittee evaluates the effectiveness and safety of a candidate for FOSHU, the rating method is not always made transparent despite being evidence based. Both manufacturers and consumers say that practical ratings should be standardized. In many health foods, there has been little scientific inquiry into the active ingredients or the exact mechanism of action. Most health foods are a combination of many ingredients. It is quite possible that any therapeutic action of a health food occurs through combined effects of FIGURE 4 The regulation system of FHC in Japan. In April 2001, the Ministry enacted a new regulation system entitled FHC. In February 2005, FOSHU divided into 4 groups on the basis of the strength of the evidence. Health claim evidence in Japan 1195S

5 TABLE 2 Nutrient function claims and attention and warnings for FNFC in Japan Nutrient Nutrition functional claims Caution Niacin Pantothenic acid Biotin Vitamin A (b-carotene) Niacin is a nutrient that helps maintain skin and mucosa in a healthy state. Pantothenic acid is a nutrient that helps maintain skin and mucosa in a healthy state. Biotin is a nutrient that helps maintain skin and mucosa in a healthy state. Vitamin A is a nutrient that helps to maintain vision in the dark. Vitamin A is a nutrient that helps maintain skin and mucosa in a healthy state. Women in first trimester pregnancy or planning to be pregnant or expecting should be careful of excess intake. In the case of b-carotene, the caution above may be omitted. Thiamin Thiamin is a nutrient that helps energy production from carbohydrates and maintains skin and mucosa in a healthy state. Riboflavin Riboflavin is a nutrient that helps maintain skin and mucosa in a healthy state. Vitamin B-6 Vitamin B-6 is a nutrient that helps energy production from protein and helps maintain skin and mucosa in a healthy state. Vitamin B-12 Vitamin B-12 is a nutrient that helps red cell formation. Vitamin C Vitamin C is a nutrient that helps maintain skin and mucosa in a healthy state and has an antioxidant effect. Vitamin D Vitamin E Folic acid Vitamin D is a nutrient that promotes calcium absorption in the intestine and aids in the development of bone. Vitamin E is a nutrient that prevents lipid in the body from oxidizing through its antioxidant effect and helps maintenance of healthy cells. Folic acid is a nutrient that helps red cell formation. Folic acid is a nutrient that contributes the normal growth of the fetus. Consuming a large quantity of the product, however, does not improve the growth of fetus. Zinc Zinc is a nutrient required to maintain healthy sense of taste. Zinc is a nutrient that helps maintain skin and mucosa in a healthy state. promote health. Because consuming a large quantity of this product may Calcium Zinc is a nutrient that is involved in protein and nucleic acid metabolism and helps heath maintenance. Calcium is a nutrient that is necessary in the development of bone and teeth. inhibit copper absorption, avoid excessive intake. Please use no more than the recommended daily intake. Infants and children should avoid this product. Iron Iron is a nutrient that is necessary in red blood cell formation. Copper Copper is a nutrient that helps red cell formation. Copper is a nutrient that helps normal functions of enzymes in the body and bone formation. Infants and children should avoid this product. Magnesium Magnesium is a nutrient required for bone and tooth formation. Magnesium is a nutrient that helps normal functions of enzymes in the body and energy production and that is required to maintain normal blood circulation. promote health. Consuming a large quantity of this product may cause soft stools (diarrhea). Please use no more than the recommended daily intake. Infants and children should avoid this product. multiple ingredients; thus, the concept of identifying a single, specific active ingredient is flawed. As a result, the Office of Health Policy on Newly Developed Foods may exempt the manufacturer from the submission of data regarding the mechanism of action for a candidate product for FOSHU. Health food manufacturers have requested that the government permit disease-risk reduction claims on FOSHU, and the government intends to do so in harmony with the Codex Alimentarius. The Office of Health Policy on Newly Developed Foods chose to classify FOSHU into 4 groups on the basis of the strength of the evidence behind a proposed relation between a substance or a product and a disease or health-related condition in February 2005 (6,8,9). The classifications are provided in Table 3. The approved reduction of disease risk FOSHU health claims, are indicated in Table 4. For the qualified FOSHU, a statement that evidence has not necessarily been established should be inserted before the description of its health use, and the term possibly must be included in the description of the health use. The role of professionals within the health food arena Health Foods exist between conventional foods and drugs, but the boundary line between health and conventional foods or between health foods and drugs is not clear. Dietitians deal with conventional foods, whereas pharmacists deal with drugs. Thus, professionals in the field of health foods are needed in Japan. 1196S Supplement

6 TABLE 3 The classifications of FOSHU Classification FOSHU ``Qualified'' FOSHU ``Standardized'' FOSHU ``Reduction of Disease-Risk'' FOSHU Content These are allowed to use labels that inform consumers who ingest the food for specific health purposes that their purpose may be achieved by consuming the product. These are allowed to use qualified or conditional labels that inform consumers who ingest the food for specific health purposes that their purpose may be achieved by consuming the product. With the aim of promoting the provision of proper information to people, it was decided to allow health claims with some conditions (qualified) under the FOSHU system for food products that do not have sufficient scientific evidence required in the course of current licensing examination procedures but are considered to have certain efficacy. These are the FOSHU for which a license/approval is granted on the basis of compliance with the separately prescribed standards. A FOSHU with a label containing any indication of a reduction of risks of developing certain diseases. At this moment, foods containing calcium or folic acid are permitted. However, in issuing an approval, the label will be required to contain a sufficient warning that the relevant disease has many risk factors and that sufficient exercise is also required for healthy life. The label also will be required to contain a sufficient warning for excessive intake. The government entrusts the training or education of the professionals to private sectors but does not nationally license them. To address this problem, the National Institute of Health and Nutrition is creating a database of evidence-based information on the effectiveness, safety, and interactions with drugs of health foods that are manufactured and marketed mainly in Japan. Any person can access the database on the website (10). Many health foods that are unknown even to specialists in the area are marketed at shops, mail-ordered, sold door-to-door, and imported privately over the Internet system in Japan. Some of these can carry illegal health claims, and others can contain medicinal or chemical components with adverse effects. A warning should be given to remove these foods from the market by the central or local government. Thus, more priority should be given to the safety, rather than the effectiveness, of such products. The National Institute of Health and Nutrition operates a network center to which information on adverse effects of such health foods is sent by monitors, most of whom are dietitians and pharmacists. If several cases with a specific adverse effect are referred to the center, the cause or the health food can be easily identified. The information is then passed on to consumers through the monitors, who are the professionals in Figure 5. It is expected that through this feedback system, largescale epidemics from unsafe additives will be preventable. Construction of a safety/effectiveness information network A major, recent problem with health foods is the presence of unreliable information on television, in magazines, and on the Internet. Reliable knowledge and information on health foods must be provided to consumers so that health foods can be used safely and with confidence. Therefore, it is necessary to provide information to consumers through each medium concerning 1) basic knowledge about health foods and the laws concerning them, 2) scientifically based information on safety/effectiveness of health foods and food elements, and 3) reports of health disturbances associated with health foods around the world. This information should be prepared and provided from the consumer s point of view. Also necessary, is an intelligent system that can effectively determine health problems that may occur in high-risk groups, when certain health foods are consumed. To execute the above-stated plans, the MHLW and the National Institute of Health and Nutrition of Japan have begun to build an information network system to collect and accumulate information related to health foods. Information about product safety is provided specifically from the consumer s point of view, and all information is based on scientific reports. This information has been posted on the homepage (10: hfnet.nih.go.jp/ in Japanese) of the National Institute of Health and Nutrition since July Although the information on this Web page can be accessed rapidly and effectively, some consumers may have difficulty understanding the material. Thus, we have provided 2 methods of accessing information, as shown in Figure 5. First, the precise method provides each consumer with individual attention through professionals such as dietitians, pharmacists, medical doctors, and researchers with direct conversation. Second, the rapid and effective method provides information through the Internet using the homepage (10). The former can provide information correctly and exactly, and the latter can give information quickly and effectively. In addition, we have created a members page, which is for professionals such as dietitians, pharmacists, medical doctors, and nutritionists who can apply to be members. On the members page, it is possible to exchange information between TABLE 4 Reduction of disease-risk FOSHU Functional ingredient Health claim approved Precautions in ingestion Calcium Daily intake of calcium from the FOSHU products should be between 300 and 700 mg. Folic acid Daily intake of calcium from the FOSHU products should be between 400 and 1000 mg. This product contains adequate calcium. Intake of a proper amount of calcium contained in healthy meals with appropriate exercise may support healthy bones of young women and reduce the risk of osteoporosis when aged. This product contains adequate folic acid. Healthy meals containing an appropriate amount of folic acid may support healthy fetal development in pregnant women and allow them to bear healthy babies by reducing the risk of neural tube defects such as spina bifida. Diseases are generally caused by various factors. Excessive ingestion of calcium will not eliminate the risk of developing osteoporosis. Diseases are generally caused by various factors. Excessive ingestion of folic acid will not eliminate the risk of giving birth to a child with a neural tube defect. Health claim evidence in Japan 1197S

7 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. FIGURE 5 Two methods for providing information to consumers. The first is a precise method through professionals, and the second is a rapid and effective method via the Internet using the homepage. and among members, who can log on as permitted by the National Institute of Health and Nutrition, to receive additions/ revisions of the provided information in the homepage and to obtain new scientific publications related to health foods. It is also possible to receive case reports resulting from the use of health foods in our country. The network between the professionals and our Institute is bidirectional, which is helpful for developing our system and providing up-to-date information for consumers. The content currently provided on the homepage includes 1) fundamental knowledge of health foods and functional foods, FHC, evaluated by MHLW, 2) current and past health problems associated with the intake of functional foods and health foods, 3) information on the ingredients and foods that have received recent attention, and 4) a database of scientifically proven information on foods and food ingredients. The use of health foods is an international trend; thus, the importation of illegal health foods from overseas is increasing, and health food problems have become increasingly complicated. Our monitoring system can help to cope with this situation. The information that we have obtained is from scientific publications and is therefore reliable, although the understanding of existing information may change when new, reliable information appears. In the future, we hope to continue with the collection and accumulation of this important information. 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. Other articles in this supplement include references (11 20). Literature Cited 1. Arai S. Studies on functional foods in Japan state of the art. Biosci Biotechnol Biochem. 1996;60: Director General, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare. Creation of the food with health claims system. Iyakuhatsu Notification No. 244, March 27, 2001 (in Japanese). 3. Shimizu T. Health claims on functional foods: the Japanese regulations and an international comparison. Nutr Res Rev. 2003;16: Tanaka H, Kaneda F, Suguro R, Baba H. Current system for regulation of health foods in Japan. J Japan Med Assoc. 2004;47: Ohama H, Ikeda H, Moriyama H. Health foods and foods with health claims in Japan. Toxicology. 2006;221: Department of Food Safety, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Revisions of handling of food for specified health uses and examination/guidance. Shokuanhatsu Notification No , February 1, 2005 (in Japanese). 7. Ministry of Health, Labor and Welfare. Dietary reference intakes for Japanese, 2005 edition. Office of Lifestyle-Related Diseases Control, Ministry of Health, Labor and Welfare, Tokyo, 2005 (in Japanese). 8. Director General, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Revision of the regulation for health food. Yakushokuhatsu Notification No , February 1, 2005 (in Japanese). 9. Ministry of Health, Labour and Welfare. 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Jew S, Vanstone CA, Antoine J-M, Jones PJH. Generic and productspecific health claim processes for functional foods across global jurisdictions. J Nutr. 2008;138:1228S 36S. 18. Ames NP, Rhymer CR. Issues surrounding health claims for barley. J Nutr. 2008;138:1237S 43S. 19. Xiao CW. Health effects of soy protein and isoflavones in humans. J Nutr. 2008;138:1244S 9S. 20. Farnworth ER. The evidence to support health claims for probiotics. J Nutr. 2008;138:1250S 4S. 1198S Supplement