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3 Food Function and Labeling Program and 4 Information Center, National Institute of Health and Nutrition, Tokyo 162-8636, Japan
* To whom correspondence should be addressed. E-mail: peaceboy{at}nih.go.jp.
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ABSTRACT |
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 TOP ABSTRACT IntroductionLITERATURE CITED |
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Introduction |
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TOPABSTRACTIntroductionLITERATURE CITED |
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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 1984. 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 information 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.
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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 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).
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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.
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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 
-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 iron-deficient anemia.
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 self-diagnosis 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.
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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 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.
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"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. 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, large-scale epidemics from unsafe additives will be preventable.
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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: http://hfnet.nih.go.jp/ in Japanese) of the National Institute of Health and Nutrition since July 2004. 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 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.
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.
Other articles in this supplement include references (11–20).
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FOOTNOTES |
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2 Author disclosures: K. Yamada, N. Sato-Mito, J. Nagata, and K. Umegaki, no conflicts of interest.
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.
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LITERATURE CITED |
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TOPABSTRACTIntroductionLITERATURE CITED |
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1. Arai S. Studies on functional foods in Japan—state of the art. Biosci Biotechnol Biochem. 1996;60:9–15.[Medline]
2. 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;16:241–52.
4. Tanaka H, Kaneda F, Suguro R, Baba H. Current system for regulation of health foods in Japan. J Japan Med Assoc. 2004;47:436–50.
5. Ohama H, Ikeda H, Moriyama H. Health foods and foods with health claims in Japan. Toxicology. 2006;221:95–111.[Medline]
6. 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. 0201002, 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. 0201001, February 1, 2005 (in Japanese).
9. Ministry of Health, Labour and Welfare. Website on revision of the regulation for "Health Food." http://www.nihs.go.jp/hse/food-info/mhlw/news/2005/050203/170203–2.html (in Japanese).
10. National Institute of Health and Nutrition. Website on safety and effectiveness information of health foods. http://hfnet.nih.go.jp/ (in Japanese).
11. Jones PJH, Asp N-G, Silva P. Evidence for health claims on foods: how much is enough? Introduction and general remarks. J Nutr. 2008;138:1189S–91S.
12. Yang Y. Scientific substantiation of functional food health claims in China. J Nutr. 2008;138:1199S–205S.
13. Tapsell LC. Evidence for health claims: A perspective from the Australia–New Zealand region. J Nutr. 2008;138:1206S–9S.
14. Asp N-G, Bryngelsson S. Health claims in Europe: New legislation and PASSCLAIM for substantiation. J Nutr. 2008;138:1210S–5S.
15. Hasler CM. Health claims in the United States: An aid to the public or a source of confusion? J Nutr. 2008;138:1216S–20S.
16. L'Abbé MR, Dumais L, Chao E, Junkins B. Health claims on foods in Canada. J Nutr. 2008;138:1221S–7S.
17. Jew S, Vanstone CA, Antoine J-M, Jones PJH. Generic and product-specific 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.
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