Foods For Specified Health Uses Research Articles

Effects of health claims on demand structure and market power: The case of the yogurt market in Japan

AbstractThis study aims to clarify the effects of health claims on consumer purchasing behavior and market power, using the Japanese yogurt market as a case study. For the analysis, the Berry, Levinsohn, and Pakes model was applied for estimations using product‐level purchasing data. The main analysis results are as follows. First, consumers prefer brands with lower prices, higher protein, lower fat, lower carbohydrates, and foods for specified health uses (FOSHU). Second, from the value of own‐price elasticity of market shares, the higher the price of a brand, the more sensitively consumers respond to price. From the value of the cross‐price elasticity of market shares, strong competition exists among FOSHU brands, and the price of R‐1 drink types tends to significantly impact the market shares of brands other than FOSHU brands. Third, the market power of each brand tends to be higher for lower‐priced brands and lower for higher‐priced brands. In terms of market power by manufacturer, Meiji has the highest both the weighted average and median values. However, both the weighted average and median values of Danone Japan are relatively lower than those of other manufacturers. Fourth, in terms of each brand's market power, brands with low prices and FOSHU labeling have high market power. These findings suggest that the acquisition of FOSHU brands in the Japanese yogurt market does not lead to a decline in market power (increase in price) and has positive effects for manufacturers, such as an increased market share.

Effects of Gain-Loss Frames on Purchase Decisions of Foods for Specified Health Uses

日本では生活習慣病予防が最重要課題であり，特定保健用食品は経済活動を通じた健康増進政策の一つである。健康増進の観点では，行動経済学・ナッジにおけるゲインフレームを用いることで健康活動を促進することが知られている。本研究はこの知見を特定保健用食品の説明文に応用し，ゲインフレームが購買意思決定に影響を与えるかどうかについて層別化RCTを用いて検証した。その結果，ロスフレームよりもゲインフレームの方がWTP（Willingness To Pay）を高めることが明らかになった。一方で，購買意思決定に対する影響は確認されなかった。ゲインフレームは主観的価値を高めるものの，購買促進に影響するかどうかはさらなる検証が必要である。健康増進と経済活動の二面性を持つ特定保健用食品では，行動経済学・ナッジおよびマーケティングの知見を組み合わせた新しいアプローチが重要である。

Food Trade for Specific Health Use FOSHU through Patents in LATAM: Relevant Aspects in International Law

Introduction: This article addresses the legal regulations for Foods for Specified Health Uses (FOSHU) in the main trade associations of Latin America (LATAM), based on the Codex Alimentarius system. Objective: The objective is to determine regulatory progress in the trade of FOSHU products. Material and methods: This study includes a review of the literature emanating from the databases from 2018 to 2022, according to the framework of three general food marketing regulations: food safety claims; inspection regulations, and food manufacturing and labeling. Results: The results reveal the absence of a specific legislation for FOSHU foods, as these are only mentioned in the area of nutrition. Conclusions: The legal framework in the trade of these products is based on jus cogens. Registration of industrial patents in the main member countries of LATAM trade associations can be facilitated through the Patent Prosecution Highway (PPH).

Quality Control and Quality Assurance for the Intermediate Zone between Food and Drug: Rational Use of Such Products and the Need to Modify the Pharmacy Education

General views on three aspects were discussed. The first aspect is regulatory categories, which can range from "soft to hard", an expression using the English and Japanese translation of the French term, "drogue douce" (soft drug). This categorization starts with "so-called health foods" and extends to Foods with Health Claims [Foods with Nutrient Functional Claims (FNFC); Foods with Functional Claims (FFC); Foods for Specified Health Uses (FOSHU)], OTC drugs, and ethical drugs. "The Basic Policy for New Drug Approval" (1967) made a distinction between OTC and prescription drugs. FOSHU (1991) originally included foods for "patients", such as low allergen rice with preventive "health claims". Foods for Medical Uses (FMU) later became an independent subcategory under Foods for Special Dietary Uses. On the other hand, manufacturers of FFC can make various "health claims" on the basis of randomized controlled trial or systematic review (2015). Products in the intermediate zone between food and drug have an annual market of over 2 trillion yen (US$ 20 billion). The second aspect is the five elements, i.e., quality, safety, efficacy, information, and cost, which are derived from WHO's "The rational use of drugs" (1985). The adoption of Sustainable Development Goals (SDGs) by the UN General Assembly (2015) led to the addition of "ecology" as the sixth element, which is applicable for herbal and animal raw materials. The third aspect is quality control and quality assurance. This initially began with manufactured products and was expanded to the service fields handled by various health workers including pharmacists.

Japan’s health food industry: An analysis of the efficacy of the FOSHU system

Health claims and their regulations have been a contended topic globally with varying degrees of standardization. Japan is one of the most advanced countries in terms of their view on the regulation of health claims and their role in the food industry. With the introduction of functional foods in 1984, Japan put health claims to use by informing consumers of specific health benefits of food products marketed and sold to them, while also cutting down on inflated and false claims made by food manufacturers. This was done with the establishment of Foods for Specified Health Uses (FOSHU) a few years later. Although extremely strict and sometimes problematic, the FOSHU system has served as a model of what functional foods could be if given the chance. Regulations in the United States differ in their beliefs that health claims should be approved based on a disease-food relationship rather than on an individual product basis. This, along with the lack of definition for functional foods, leads to a poorly organized health food sector in the United States. FOSHU is highly regarded and well trusted in Japan; so much so that FOSHU products and packaging helps promote non-FOSHU products with similar appearance. Yet, despite the system’s tightly controlled mechanism, its efficacy and comprehensiveness to the average consumer has come under question. Due to tight regulations and the high costs and long wait times of developing FOSHU products, many small businesses find it difficult to apply for them. Subsequently, this trickles down to consumers and inhibits lower-income populations from purchasing these products. Additionally, the effectiveness of FOSHU products outside of a clinical setting has come into question from the scientific community. Factors including poor consumer education regarding FOSHU, as well as clinical settings that do not mimic the daily life of consumers have produced unsatisfactory results in the general public. Keywords: FOSHU, Health Claims, Functional foods, After market research, Clinical setting, functional/active ingredient, FOSHU seal

Effect of Regular Exercise and Functional Beverages on Changes in Body Weight and Waist Circumference in Healthy Japanese Subjects.

Background and objectives: The effects on anthropometry of several lipid-related foods for specified health uses (FOSHU) approved in Japan are not well known. We examined the effects of regular exercise and lipid-related FOSHU beverages on changes in body weight (BW) and waist circumference (WC) among factory and office workers. Materials and Methods: A total of 3002 subjects aged 20 years or older (2497 men and 505 women) received health check-ups in 2015 and 2016 and completed a lifestyle questionnaire. The association between regular exercise or lipid-related FOSHU beverage intake and changes in BW or WC were evaluated using trend test and linear regression analysis. Results: Regular exercise (≥1/week) was reported by 774 subjects (25.8%), and regular consumption of lipid-related FOSHU beverages (≥1/week) was reported by 1168 subjects (38.9%). The significant association between lipid-related FOSHU beverage intake and changes in BW was only observed among subjects with regular exercise (p for trend = 0.042). In the multivariable analysis, sex, older age, baseline weight, baseline body mass index (BMI), and regular exercise behavior were significantly associated with smaller changes in BW (p < 0.05). In WC, only the baseline values of WC and BMI were associated with one-year changes of WC. Conclusions: The combination of regular exercise and lipid-related FOSHU may be effective in maintaining BW.

Simultaneous Determination of Catechins and Caffeine in Green Tea-Based Beverages and Foods for Specified Health Uses

Catechins in green tea have various useful features including antioxidant activity and preventive effects on metabolic syndrome. Various beverages that are enriched with tea catechins are marketed as Foods for Specified Health Uses (FOSHU) in Japan. However, recent reports have indicated that excessive consumption of green tea extracts as a dietary supplement are associated with adverse health effects such as liver disorders. Various catechins and caffeine are constituents of FOSHU tea-based beverages. The amount of catechins in FOSHU products is displayed on labels as total catechin content, but the content of individual catechins are not provided. Although health hazards of FOSHU products have rarely been reported, precise information about the content and types of catechins in FOSHU products is needed to ensure safety. We used high-performance liquid chromatography with a photodiode array (HPLC/PDA) to simultaneously identify and quantify catechins and caffeine in green tea-based popular beverages and FOSHU beverages. This technique allowed simultaneous quantitation of five types of catechins and caffeine in green tea without complicated sample preparation. Epigallocatechin gallate (EGCG) and epigallocatechin EGC were the main catechins in various FOSHU beverages and the concentrations of almost all catechins were higher in FOSHU, than in popular green tea-based beverages. The concentrations of EGCG in green tea-based popular beverages and in FOSHU beverages were 5.4 - 7.3 and 10.2 - 41.9 mg/100mL, respectively, with the highest concentration being in a product named Healthya (approximately 147 mg/bottle). The simultaneous determination of compounds such as catechins and caffeine in FOSHU beverages can help to estimate beneficial and adverse effects to prevent deleterious effects on health and the excessive consumption of FOSHU beverages containing high concentrations of tea catechins should be avoided.

Establishing Self‐regulatory Guideline for the Functional Claims of Health Foods Including Dietary Supplements in Japan

Within the scopeof the Revitalization Strategypolicies and elongating healthy life span, government of Japan has been in the process to set a new labeling system of health claims for processed foods and fresh foods, in which industries can describe functionality based on scientific evidence under industry responsibility, without individual reviews by the government that is currently required for Foods for Specified Health Uses. This new labeling rule is referred to the labeling system of the dietary supplement in the US. Government of Japan explored the way of appropriate labeling. A consumer survey was conducted in 2014 to clarify basic knowledge regarding currently revealed issues such as the evidence level to determine functionality labeling and the readability of the labeling among general consumers including specific population assumed to easily misunderstand health claims. Based on the survey results, issues and the new system will be discussed by relevant experts. The new rule is planned to be finalized and implementedby March 2015. This will be a major shift in the food functionality labeling system. An overview of the perspective of the studies on the new functionality labeling system, with focuses on the meaning of the cabinet decision statement and the main issues that are anticipated in the future, will be presented.

Achievements and discoveries as to functional foods in Japan (813.14)

The term and concept of “functional foods” were created in the course of “Grant‐in‐Aid” research sponsored by the Japanese Ministry of Education, Science and Culture in 1980s. Functional foods are defined as those that modulate body function and prevent certain diseases. Since then, numerous studies have been conducted as to the physiological functions of food factors. The Japanese Ministry of Health and Welfare established a policy to approve some of the selected functional foods as “foods for specified health uses (FoSHU)” in 1991 to share the benefit of results obtained by the research works and provide people with healthy foods manufactured on the basis of scientific achievements. At present, the Customers Affairs Agency is responsible for the approval, and over 1,000 items have been approved as FoSHU. FoSHU products are categorized into 10 according to their functions such as modulation of gastrointestinal condition, serum cholesterol level, serum triacylglycerol level, blood pressure and blood sugar level, acceleration of mineral absorption and promotion of bone health. Interestingly, functional factors in products of the same function often differ in their mechanism of action, while the same functional factor is contained in products of different functions. Therefore, this presentation will summarize some of the functional factors according to their properties and characteristics to get a hint for the strategy to design novel functional foods.

New Japanese Yogurts Using Functional Probiotic Lactic Acid Bacteria and Future Strategies to Protect Human Gut

In Japan, milk and food companies have recently developed many functional yogurts using selected probiotic lactic acid bacteria (LAB) and Bifidobacterium strains. In 1991, the FOSHU (foods for specified health uses) system began instituted by the Ministry of Health, Labor and Welfare. In 2010, approximately 1,000 commercially available items were labeled as FOSHU products that are specially given brands showing good health effects for humans. Japanese commercial yogurts are classified into three type categories: fermented using selected probiotics, functional components added, and standard types. Many functions are considered in the selection of probiotics including competitive adhesion exclusion of enteritic pathogens, cholesterol lowering effects, and positive immuno-modulatory effects. Adhesion to the human intestine is one of the most important characteristics of probiotic LAB and bifidobacteria. Our new screening system for adhesive activity involves a combination of three methods: the rat colonic mucin-micro plate assay, the Carnoy’s histochemical staining method, and the carbohydrate probe binding assay. Recently, we developed a new screening assay using the BIACORE biosensor chip coated with human colon mucin (HCM). We found new LAB strains that recognize and specifically bind to the human ABO blood type antigens. We named these “blood type LAB”. We identified the molecular LAB binding mechanism occurring in the human intestine through unique adhesin molecules that are expressed on the bacterial cell surface as lectin-like proteins. Bacteria with strong adhesion ability improve gastrointestinal health by continuous proliferation in the intestine; and increase the chance of intake into the Peyer’s patches through M-cells that inhibit allergies because of LAB immune-stimulating activity. The future Japanese food market will contain superior functional yogurts containing adhesive effective probiotic LAB and bifidobacteria that are expected to be developed using our proposed mass screening system shown here.

Enhancement or Suppression of ACE Inhibitory Activity by a Mixture of Tea and Foods for Specified Health Uses (FOSHU) That Are Marketed as “Support for Normal Blood Pressure”

The ACE inhibitory activities of mixtures of FOSHUs (Healthya, Goma-Mugicha, Lapis Support and Ameal) were examined in order to identify any antihypertensive interactions. Among combinations of Healthya with other samples that contain active peptides, only that with Ameal was found to have no inhibitory activity. Enhanced activity was observed in 2 other mixtures. The activity of a mixture of tea polyphenols and the whey component extracted from an Ameal solution was significantly decreased, thus demonstrating that whey protein lowered the ACE inhibitory activity of Healthya. Although oral administration of tea polyphenols alone significantly decreased SBP in SHR at 2 and 4 hr, combined administration with Ameal failed to decrease SBP at the same time points. In conclusion, the simultaneous intake of tea and FOSHUs that contain active peptides might affect daily self-antihypertensive management via enhancement or suppression of ACE inhibitory activity.

Anti-hyperglycemic and anti-hyperlipidemic effects of guava leaf extract

Psidium guajava Linn. (guava) is used not only as food but also as folk medicine in subtropical areas around the world because of its pharmacologic activities. In particular, the leaf extract of guava has traditionally been used for the treatment of diabetes in East Asia and other countries. Moreover, the anti-hyperglycemic activity of the extract has been reported in some animal models. However, little is known regarding the therapeutic activity of the extract in human clinical trials as well as its underlying therapeutic mechanisms and safety. In Japan, Guava Leaf Tea (Bansoureicha®, Yakult Honsha, Tokyo, Japan) containing the aqueous leaf extract from guava has been approved as one of the Foods for Specified Health Uses and is now commercially available. This review describes the active component of the aqueous guava leaf extract and its inhibition of alpha-glucosidase enzymes in vitro, safety of the extract and Guava Leaf Tea, reduction of postprandial blood glucose elevation, and improvement of hyperglycemia, hyperinsulinemia, hypoadiponectinemia, hypertriglycemia and hypercholesterolemia in murine models and several clinical trials. It is suggested that the chronic suppression of postprandial blood glucose elevation is important in preventing type 2 diabetes mellitus, and that Guava Leaf Tea is considered useful as an alimentotherapy for chronic treatment.

Foods with Health Claims in Japan

The Japanese Ministry of Health, Labour and Welfare (MHLW) established the “Foods for Specified Health Uses (FOSHU)” designation in 1991 as a regulatory system for the approval of health claims on labels that refer to the physiological effects of foods or food components on the human body. This labeling system has been revised twice, most recently in 2005. Thus, “Food with Health Claims” (FHC) in Japan consists of two categories. One is “Foods with Nutrient Function Claims” (FNFC), for which health claims on labels can be freely used if the product satisfies the standard for the minimum and maximum levels per daily portion of consumption; the other is FOSHU. FOSHU are foods that contain beneficial dietary ingredients that maintain or promote human health, or that improve risk factors for lifestyle-related diseases. In the present system, FOSHU health claims are individually reviewed and approved on the basis of scientific evidence. In addition to the existing FOSHU, three new types of classifications were established in February 2005: the new regulatory standards of “Standardized FOSHU” and “Qualified FOSHU” and the new health claim “Reduction of disease risk”.

Prevention of osteoporosis by foods and dietary supplements. What are foods for specified health uses (FOSHU)?

Foods for specified health uses (FOSHU) are foods to which a "functional" ingredient has been added for a specific healthful effect. Approved by the Ministry of Health, Labour and Welfare, these foods have been designed to maintain and promote good health. Main guidelines for application, evaluation and labeling for FOSHU is following. (1)FOSHU should be evaluation in its effectiveness and safety scientifically by the Council of Pharmaceutical affairs and Food Hygiene and Food Safety Commission. (2)Functional labeling of FOSHU should be on science basis, but should not imply prevention, treatment and diagnosis of human disease.

Prevention of osteoporosis by foods and dietary supplements. "Mainichi Hone Kea MBP": A foods for specified health uses (FOSHU) product containing MBP that has an effect to increase bone density

"Mainichi Hone Kea MBP" is a foods for specified health uses (FOSHU) product. It has been approved to write the next claim, "This product is suitable for those who care about bone health, because it contains MBP that has an effect to increase bone density", on this product. MBP is a complex of protein with a basic isoelectric point in milk protein. It has been shown that MBP promotes bone formation, suppresses bone resorption, increases bone mineral density, and increases bone strength in in vitro and in vivo studies. And, we also examined the effect of MBP in healthy adult women from twenties to fifties. A beverage containing MBP or a placebo beverage without MBP was given to volunteers for six months. The percentage increase of radial bone density was significantly higher in the MBP group than in the placebo group. This result has confirmed that MBP contributes to increased bone density in humans. To sum up, we believe that MAINICHI HONE KEA MBP, which contains MBP that has an effect to increase bone density, contributes to bone health.

Key factors for the success of functional foods

The concept of Functional Food originates in a research project started in 1984. It triggered the introduction of a health claim system for Foods for Specified Health Uses (FOSHU) in 1991. In parallel with the implementation and subsequent regulatory changes, the administration has been intensifying its control over so-called health foods and the FOSHU examination has become more stringent. In spite of the unfavorable regulatory circumstances, being inspired by academic society, many of the food industries have developed functional foods and launched them into the market as FOSHU products to bring about an annual increasing rate of 130% in the total sales amount. On the other hand, the public concern about health and nutrition is soaring. Consumers are becoming more alert to health claims and seeking much more advanced information about food products than before. Taking all of this into account, the key factors for the success of functional foods could be summarized in the following four points. 1) Use of innovative technology in scientific developments resulting in health benefits 2) A variety of new functional foods to be developed by the industries 3) Amendment of functional foods' regulations 4) Improving the consumer's understanding and knowledge of foods claiming a health benefit.

Nutrition labelling and claims: Concerns and challenges; experiences from the Asia Pacific Region

Nutrition labelling and claims: Concerns and challenges; experiences from the Asia Pacific Region

Functional food science in Japan: state of the art.

In 1984, a new science related to functional food was initiated by a National Project team under the auspices of the Japan Ministry of Education and Science. It was followed by a great many academic and industrial studies to occupy a central position in the field of food and nutritional sciences. In 1993, the Ministry of Health and Welfare established a policy of "Foods for Specified Health Uses" (FOSHU) by which health claims of some selected functional foods are legally permitted. Up to now (November 22. 1999), 167 FOSHU products have been born. Since the time (1984) when the concept of functional food" was proposed, it seems that the science in Japan has been progressing along, among others, a unique path of development. The uniqueness is seen in the development of functional foods by minimizing undesirable as well as maximizing desirable food factors. Hypoallergenic foods, developed from their materials by removing allergens, offer a good example. Another characteristic may be found in the field of sensory science which aims at elucidating a molecular logic of the senses of taste and smell in reference to their effects on physiological systems in the body. The paper discusses some characteristics of functional food science in Japan, with special emphasis on these topics.