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Japanese model shifting toward prevention.
May 1, 2001
By: Ron Bailey
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Diabetes has become a serious medical problem in Japan, just as it is in the U.S. Official Ministry of Health and Welfare data from 1998 indicated that diabetes ranked tenth in Japan in terms of official causes of death (cancer was first). The pharmaceutical industry in Japan is heavily involved with new prescription drug therapies for the treatment of the disease, as would be expected. However, there are also non-drug approaches to preventing and controlling diabetes in Japan. Estimates obtained from various Japanese sources indicate that there are at least seven million diabetics in Japan at the present time, mostly (95%) adults with non-insulin dependent diabetes. This compares with the U.S. figure of around 16 million diabetics, which is roughly comparable since the U.S. population is more than double that of Japan. The incidence of diabetes in Japan increases as the population ages, just as in the U.S., with the highest incidence currently in the 50-60 year old age group. Since Japan continues to have the most rapidly aging population in the world, this is a great cause for concern in the health care community. One estimate has put the number of Japanese at risk of developing diabetes at more than ten million people, which would be approximately 8% of the population. The Ministry of Health, Labor and Welfare (previously the Ministry of Health and Welfare) has the primary government responsibility for helping to maintain the health of the population. Some time ago a regulatory category for special foods called “Foods for the Sick” was created under the formal Foods for Special Dietary Uses regulations. Included in the Foods for the Sick category are “Assorted Foods for Diabetes,” which are allowed to obtain a government Permit Seal and use an official logo. The foods in this category tend to be similar to the foods recommended by the American Diabetes Association, in this case for people who already have diabetes. The recent Ministry emphasis appears to be shifting to diabetes prevention, however, as a more promising approach to controlling the problem in Japan. The primary non-drug approaches to the diabetes problem in Japan center around weight loss and control of blood sugar, which would be expected. There is concern in Japan about the increase in the incidence of overweight and obesity (sounds familiar, doesn’t it?), as the Japanese diet becomes more “Westernized” and as young people are increasingly out-of-shape and reluctant to exercise. There is also concern about the increased intake of refined sweeteners in soft drinks and processed foods, just as in the U.S.
Until fairly recently, weight loss claims were not allowed to be made openly for food products and ingredients, although implied diet claims were often used in the creative naming of the products. As recently as five years ago the Nikkei Weekly English-language newspaper reported the arrest of a health food company chairman for the sale of a health food that used newspaper claims that the tablets were “effective against diabetes” and could help the customer lose “1.5 kg in a month.” Both claims were considered potential violations of the Pharmaceutical Affairs Law, which prohibits the sale of medicine without a license. The regulatory climate has changed, however, and it is now possible to find many non-drug “diet” products and ingredients positioned for weight loss to help prevent adult diseases such as diabetes, although overt drug claims are still not allowed. Here are examples from recent trade shows in Japan. 1. Garcinia cambogia fruit powder concentrate from Thailand and India, which is often claimed to be a successful weight loss product in the United States as a point of interest to consumers. 2. Chitosan processed crab shell extract from Japan and other countries, often with fat absorption claims based on in vitro data, some of which has been generated in the U.S. 3. Chinese teas of various types, mostly based on historical use in China, rather than weight loss clinical study data generated in Japan. 4. Konnyaku glucomannan non-caloric fiber from Japan, which is used in many common low-calorie foods including pastas, desserts, snacks, etc. and is a traditional Japanese food consumed for its fiber-related benefits. 5. Gymnema sylvestre Ayurvedic herb from India, often in combination with other weight loss ingredients and often positioned as a natural appetite suppressant given its ability to block sweet taste in the mouth. This was the ingredient used in the arrest case cited above, so the users are particularly careful to avoid making potential drug claims.
This has become a more active area of development in Japan because blood glucose control claims can be made with the approval of the Ministry, without mentioning the diabetes disease condition directly. Many examples can be found at trade shows and in the public literature. 1. FOSHU (Foods for Specified Health Use)—Several products have been approved by the Ministry in this special regulatory category, with on-label claims that the product “…helps moderate the absorption of sugars” or something equivalent. The functional components used to support these claims include indigestible dextrin from Matsutani Kagaku, guava leaf polyphenols from Yakult Honsha and wheat albumin from Nisshin Flour Milling. 2. JapanScan References—Blood glucose control ingredients being positioned for use in various functional foods and nutraceuticals cited in recent issues of JapanScan Food Industry Bulletin include fenugreek gum from China, golden vein lotus from Taiwan, Salacia oblongati tea from India, and green tea polysaccharides, black soybean extract and akamoku seaweed from Japan. Patents have also been applied for using perilla extract and curdlan for a similar purpose. These are just a few examples from recent issues of this publication. 3. Trade Shows Sources—Recent trade shows in Japan have also exhibited a range of additional blood glucose-lowering ingredients, including evening primrose seed extract, mulberry leaf extract and banaba leaf extract as relatively new commercial ingredients, plus more traditional food ingredients such as psyllium seed husk, konnyaku flour and maitake mushroom extract.
More natural ingredients will be identified that can be shown to suppress blood glucose levels in vivo , as has been demonstrated for many (if not all) of the examples used in this summary. Some of the ingredients will show sufficient promise to warrant FOSHU-level human clinical testing, with the target of eventual FOSHU regulatory approval in Japan. New ingredients from the U.S. such as various resistant starches and new diabetes control and weight loss concepts, such as the “Syndrome X” diet, will be evaluated in Japan as well. There is no question that the need for such non-drug options will increase, particularly with the current emphasis on prevention of the disease rather than treatment after diabetes has been confirmed. NW
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