Ron Bailey03.01.04
In many respects, Japan has become something of a "crystal ball" for predicting the future of functional foods and nutraceuticals in developed and developing countries. Many of the issues that Japan as a country is faced with-flat to declining rapidly aging population, serious overcrowding in the major cities, escalating healthcare costs, increasing rates of diabetes and "pre-diabetes"-are happening in other countries as well but have not yet reached the same level of concern. Japan on the other hand has been dealing with these realities for several years. As a result, it already has concrete programs in place to address each of these important issues.
FOSHU: The success of the FOSHU (Foods for Specified Health Uses)-"Tokuho" in Japanese-category has been well documented recently. There are now just over 400 FOSHU products approved for sale in Japan, with sales of at least $4 billion at retail. And it is expected that the next formal sales report from the Japan Health Food and Nutrition Food Association (JHNFA) will show considerable growth from the previous figure. All of this FOSHU market growth occurred in only the last 10 years.
FNFC: At the same time, JHNFA has reported that retail sales of foods and beverages (including dietary supplements) using the newer Foods With Nutrient Function Claims (FNFC) regulatory system in 2003 are expected to be nearly $2 billion, up from approximately $1 billion in 2001. Products in this category are allowed to make generic health claims based on the vitamin and/or mineral content of the product, both naturally occurring and/or fortified.
JHFA: The Japan Health Food Association (JHFA), which is part of JHNFA, has developed with industry support 53 standards for various health foods, to try to maintain some semblance of order in this unruly part of the market. The JHNFA has indicated, however, that only about 900 of the more than 50,000 health food products are using the JHFA standards and logo. JHNFA also indicated at the recent British Columbia Functional Food and Nutraceutical Network FOSHU conference that products with "illegal" claims are a serious problem in the less regulated $7 billion "Other Health Foods" category in Japan.
On the more positive side, there have been some very high profile Japanese successes that are now being marketed in other countries. One example is the Kao Corporation Econa cooking oil that was granted FOSHU status in 1998 based on its diacylglycerol functional ingredient for blood lipid control, which is now a $200 million retail brand in Japan. Econa diacylglycerol is also being used in Japan in a wide range of non-FOSHU functional foods, from bread to mayonnaise to salad dressing to margarine. Kao Corporation has formed a joint venture with ADM, Decatur, IL, in the U.S. for the sale of a diacylglycerol oil called Enova, which is now in U.S. test markets. The joint venture was able to obtain official FDA GRAS status for the ingredient, in part based on the technical data (including human clinical studies) and commercial experience in Japan. This is another indication that the FOSHU regulatory standard is quite high and suitable for functional foods in countries outside Japan.
Over the past few years, there has been a series of food safety crises that have shocked the food and beverage industry in Japan, including dietary supplements. Misbranded meat products, gross dry milk microbiological contamination, "mad cow" disease (including a young "mad bull" recently), adulterated imported weight loss products and imported vegetables with unapproved pesticides have all made headlines. Many of the problems were caused by negligence and some by simple greed but these issues have prompted the primary regulatory agencies (Ministry of Health, Labor, and Welfare and Ministry of Agriculture, Forestry, and Fisheries in particular) to refocus their efforts on hygiene and food safety.
Examples of the impact of this official refocusing would include:
Possible extension of FOSHU approval times: JHNFA representatives have indicated that the new involvement of the Food Safety Commission in the approval process could delay approvals by perhaps three to six months (from the current six month target).
Restrictions on "off-label" claims: It is being reported that some prefectural bureaucrats in Japan are allowing only the generic FNFC claims for vitamins and/or minerals both on- and off-label for new FNFC products. This restriction does not allow new supporting technical information to be used, or even old information from Japan and elsewhere that is beyond the generic claim.
Restrictions of imports from "mad cow" countries: At press time, imports of bovine-sourced gelatin capsules from the U.S. with non-FOSHU ingredients such as herbs are not being allowed, even if the capsules are sourced from a non- "mad cow" country but are filled in the U.S.
Increased interest in organic food and beverage ingredients: Although the organic market has been growing for several years, it has been difficult for Japan in particular, with very small densely packed farms, to take full advantage of this market. However, consumer and regulatory pressure is making the organic option more attractive.
The positive FOSHU product experience has become a model in many ways for the regulation of other food and beverage categories. None of the crises mentioned have involved FOSHU products, and it is believed that the FOSHU logo with the MHLW approval as part of that logo has further enhanced the credibility of the category in the minds of the consumers.
There are several elements involved in trying to predict the future of the functional foods and nutraceuticals markets in Japan. It is made easier in some respects, however, by the annual data collection and reporting in Japan on nutrition, disease states, causes of death, aging statistics, etc. A primary difference in Japan is that the collected data seem very quickly to become the basis for reasonably consistent and focused government policies. The bureaucrats in Japan are not immune from politics of course, but the "common good" is a major driving force in the areas of public health policy.
Demographics Predictions. The population will continue to age rapidly, comparable to Italy, which are among the highest in the world. Longevity will continue to increase, for both males and females, with some slowing but still maintaining the title of the longest-living population in the world. The population will peak at just around 127 million, and then begin a long decline to perhaps only 100 million by 2050, because the birth rate is not going to increase significantly and the restrictive immigration policies will stay in place.
Health Predictions. Cancer rates will continue to decline as the incidence of smoking (particularly for men) decreases. Diabetes incidence will continue to increase, although at a rate lower than that of most developed nations because the incidence of obesity in Japan is much lower (as defined by a Body Mass Index of 30 or greater). A major focus for functional foods and nutraceuticals will be on the pre-diabetes Metabolic Syndrome elements (blood glucose, blood pressure, blood lipids), including new FOSHU product health claims. Functional foods and nutraceuticals will also focus more attention on the growing rates of allergy and asthma, particularly amongst children, probably outside the FOSHU category. Weight loss and weight maintenance will receive even more attention, and will eventually be allowed in the FOSHU category as a measurable "health claim" to encourage participation, but with improved regulatory controls.
Food Safety Predictions. "Mad Cow" will remain a controlled problem, with continued testing of each and every cow prior to slaughter. Farmed fish will be fed a more natural diet, including coloring agents such as astaxanthin, and will be nearly PCB and dioxin-free. Organic produce will be encouraged, including organic produce grown overseas with Japanese-level quality control systems in place. Short shelf-life refrigerated foods will continue to be the industry standard, using natural preservatives whenever possible. "Non-GMO" will continue to be considered a consumer-friendly label claim, with the acceptance of the government.
Environmental Predictions. Japanese consumers will continue to recycle food and beverage packaging materials at rates higher than most other countries in the world. Beverage packaging in particular will focus on ease of disposal for recycling. Incineration and landfill disposal techniques will be improved, but with a consumer preference for recycling and/or biodegradable packaging materials.
As a final comment, it is clear that the conditions are right in Japan for even more rapid growth of science-based and safe foods, beverages and dietary supplement products with proven health-related efficacies. A key difference in Japan as compared with many other countries is that the government is a willing partner in the effort, as long as the health of the consuming population is not compromised, but only maintained or improved.NW
About the author:
Ron Bailey is president of California Functional Foods, Ashland, OR. He can be reached at 541-488-3184 or E-mail: bailey@mind.net.
*Note: Important sources of information for this article included the Japan Health Food and Nutrition Food Association (JHNFA) in Tokyo, the Ministry of Health, Labor, and Welfare (MHLW) in Tokyo and the proceedings of the British Columbia Functional Food and Nutraceuticals Network Conference in Vancouver, B.C., on November 24, 2003.
Trends and Issues
FOSHU: The success of the FOSHU (Foods for Specified Health Uses)-"Tokuho" in Japanese-category has been well documented recently. There are now just over 400 FOSHU products approved for sale in Japan, with sales of at least $4 billion at retail. And it is expected that the next formal sales report from the Japan Health Food and Nutrition Food Association (JHNFA) will show considerable growth from the previous figure. All of this FOSHU market growth occurred in only the last 10 years.
FNFC: At the same time, JHNFA has reported that retail sales of foods and beverages (including dietary supplements) using the newer Foods With Nutrient Function Claims (FNFC) regulatory system in 2003 are expected to be nearly $2 billion, up from approximately $1 billion in 2001. Products in this category are allowed to make generic health claims based on the vitamin and/or mineral content of the product, both naturally occurring and/or fortified.
JHFA: The Japan Health Food Association (JHFA), which is part of JHNFA, has developed with industry support 53 standards for various health foods, to try to maintain some semblance of order in this unruly part of the market. The JHNFA has indicated, however, that only about 900 of the more than 50,000 health food products are using the JHFA standards and logo. JHNFA also indicated at the recent British Columbia Functional Food and Nutraceutical Network FOSHU conference that products with "illegal" claims are a serious problem in the less regulated $7 billion "Other Health Foods" category in Japan.
On the more positive side, there have been some very high profile Japanese successes that are now being marketed in other countries. One example is the Kao Corporation Econa cooking oil that was granted FOSHU status in 1998 based on its diacylglycerol functional ingredient for blood lipid control, which is now a $200 million retail brand in Japan. Econa diacylglycerol is also being used in Japan in a wide range of non-FOSHU functional foods, from bread to mayonnaise to salad dressing to margarine. Kao Corporation has formed a joint venture with ADM, Decatur, IL, in the U.S. for the sale of a diacylglycerol oil called Enova, which is now in U.S. test markets. The joint venture was able to obtain official FDA GRAS status for the ingredient, in part based on the technical data (including human clinical studies) and commercial experience in Japan. This is another indication that the FOSHU regulatory standard is quite high and suitable for functional foods in countries outside Japan.
Regulatory and Food Safety Concerns
Over the past few years, there has been a series of food safety crises that have shocked the food and beverage industry in Japan, including dietary supplements. Misbranded meat products, gross dry milk microbiological contamination, "mad cow" disease (including a young "mad bull" recently), adulterated imported weight loss products and imported vegetables with unapproved pesticides have all made headlines. Many of the problems were caused by negligence and some by simple greed but these issues have prompted the primary regulatory agencies (Ministry of Health, Labor, and Welfare and Ministry of Agriculture, Forestry, and Fisheries in particular) to refocus their efforts on hygiene and food safety.
Examples of the impact of this official refocusing would include:
Possible extension of FOSHU approval times: JHNFA representatives have indicated that the new involvement of the Food Safety Commission in the approval process could delay approvals by perhaps three to six months (from the current six month target).
Restrictions on "off-label" claims: It is being reported that some prefectural bureaucrats in Japan are allowing only the generic FNFC claims for vitamins and/or minerals both on- and off-label for new FNFC products. This restriction does not allow new supporting technical information to be used, or even old information from Japan and elsewhere that is beyond the generic claim.
Restrictions of imports from "mad cow" countries: At press time, imports of bovine-sourced gelatin capsules from the U.S. with non-FOSHU ingredients such as herbs are not being allowed, even if the capsules are sourced from a non- "mad cow" country but are filled in the U.S.
Increased interest in organic food and beverage ingredients: Although the organic market has been growing for several years, it has been difficult for Japan in particular, with very small densely packed farms, to take full advantage of this market. However, consumer and regulatory pressure is making the organic option more attractive.
The positive FOSHU product experience has become a model in many ways for the regulation of other food and beverage categories. None of the crises mentioned have involved FOSHU products, and it is believed that the FOSHU logo with the MHLW approval as part of that logo has further enhanced the credibility of the category in the minds of the consumers.
Future Predictions
There are several elements involved in trying to predict the future of the functional foods and nutraceuticals markets in Japan. It is made easier in some respects, however, by the annual data collection and reporting in Japan on nutrition, disease states, causes of death, aging statistics, etc. A primary difference in Japan is that the collected data seem very quickly to become the basis for reasonably consistent and focused government policies. The bureaucrats in Japan are not immune from politics of course, but the "common good" is a major driving force in the areas of public health policy.
Demographics Predictions. The population will continue to age rapidly, comparable to Italy, which are among the highest in the world. Longevity will continue to increase, for both males and females, with some slowing but still maintaining the title of the longest-living population in the world. The population will peak at just around 127 million, and then begin a long decline to perhaps only 100 million by 2050, because the birth rate is not going to increase significantly and the restrictive immigration policies will stay in place.
Health Predictions. Cancer rates will continue to decline as the incidence of smoking (particularly for men) decreases. Diabetes incidence will continue to increase, although at a rate lower than that of most developed nations because the incidence of obesity in Japan is much lower (as defined by a Body Mass Index of 30 or greater). A major focus for functional foods and nutraceuticals will be on the pre-diabetes Metabolic Syndrome elements (blood glucose, blood pressure, blood lipids), including new FOSHU product health claims. Functional foods and nutraceuticals will also focus more attention on the growing rates of allergy and asthma, particularly amongst children, probably outside the FOSHU category. Weight loss and weight maintenance will receive even more attention, and will eventually be allowed in the FOSHU category as a measurable "health claim" to encourage participation, but with improved regulatory controls.
Food Safety Predictions. "Mad Cow" will remain a controlled problem, with continued testing of each and every cow prior to slaughter. Farmed fish will be fed a more natural diet, including coloring agents such as astaxanthin, and will be nearly PCB and dioxin-free. Organic produce will be encouraged, including organic produce grown overseas with Japanese-level quality control systems in place. Short shelf-life refrigerated foods will continue to be the industry standard, using natural preservatives whenever possible. "Non-GMO" will continue to be considered a consumer-friendly label claim, with the acceptance of the government.
Environmental Predictions. Japanese consumers will continue to recycle food and beverage packaging materials at rates higher than most other countries in the world. Beverage packaging in particular will focus on ease of disposal for recycling. Incineration and landfill disposal techniques will be improved, but with a consumer preference for recycling and/or biodegradable packaging materials.
As a final comment, it is clear that the conditions are right in Japan for even more rapid growth of science-based and safe foods, beverages and dietary supplement products with proven health-related efficacies. A key difference in Japan as compared with many other countries is that the government is a willing partner in the effort, as long as the health of the consuming population is not compromised, but only maintained or improved.NW
About the author:
Ron Bailey is president of California Functional Foods, Ashland, OR. He can be reached at 541-488-3184 or E-mail: bailey@mind.net.
*Note: Important sources of information for this article included the Japan Health Food and Nutrition Food Association (JHNFA) in Tokyo, the Ministry of Health, Labor, and Welfare (MHLW) in Tokyo and the proceedings of the British Columbia Functional Food and Nutraceuticals Network Conference in Vancouver, B.C., on November 24, 2003.