Ron Bailey07.01.06
This update focuses on recent developments in the regulation of functional foods and nutraceuticals in Japan. With nearly 600 individual product approvals, the most dramatic growth has taken place in the FOSHU (Foods for Specified Health Uses, "Tokuho" in Japanese) market in Japan. This market has developed over the past 13 years and is currently worth $6 billion at retail.
Although the official report on the FOSHU market prepared by the Japan Health Food and Nutrition Food Association (JHNFA) indicates that FOSHU sales grew only 11% between 2003 and 2005, the opportunity for new FOSHU functional ingredients and products with new health claims remains strong. Truly new health claims are less common, however, in part related to the time and expense necessary to develop the clinical data in support of the claims being sought. Even though there were 171 new FOSHU product approvals during the past two years, most of the new products were formulated with previously approved functional ingredients (i.e., indigestible dextrin for intestinal health or blood glucose control).
In its official FOSHU summary, JHNFA does list 10 new "active" ingredients in FOSHU products approved in 2004 and 2005. There were five blood pressure control ingredients: wakame (a seaweed) peptide, nori (another seaweed) penta-peptide, sesame peptide, acetic acid and GABA (gamma-aminobutyric acid). LC1 lactic acid bacteria, bifidus Bb12 (Bifidobacterium lactis), and coffee bean manno-oligosaccharide (mannobiose) were approved as gut regulation active ingredients. Green tea fluoride for tooth health and a broccoli and cabbage-derived natural amino acid for cholesterol control were the final two new actives.
There are unofficial reports from Japan that a new FOSHU health claim category related to fatigue and/or stress is expected to be approved, perhaps by this time next year. A consortium of companies is generating the necessary supporting information for the new category, including development of appropriate biomarkers and analytical procedures, as well as possible claims and clinical study expectations. There are similar reports that the important weight loss/weight maintenance category will also gain FOSHU status over the next couple of years. If just these two new categories are accepted by the Ministry of Health, Labor and Welfare (MHLW), the FOSHU market potential will significantly increase, as each of the categories is already active in Japan in a non-FOSHU format.
At the same time, the FOSHU umbrella has expanded in other ways to allow a broader range of health claims in a modified format. These are referred to as the "New" FOSHU by JHNFA in its May 2006 publication entitled "Claims Regulation in Japan," defined as:
• Qualified Claims for FOSHU: no established evidence, but test results suggest evidence
• Standardized Claims for FOSHU: clinical trials necessary for safety only (limited to three dietary fibers and six oligosaccharides)
• Reduction of Disease Risk Claims for FOSHU: calcium and osteoporosis, folic acid and neural tube disease
Although there is interest in the qualified claims opportunity in particular, as it would seem to encourage the use of new "active" ingredients, in practice there are no marketed products using such qualified claims. Two new products have apparently been "approved," although it is not yet clear if the qualified claims permitted will be identified on the label as having come from the new regulatory process.
This is the other formal category of foods with health claims in Japan that allows specific on-label claims, but in this case without the need for prior product approval by the Ministry. The category allows claims for 12 vitamins and five minerals, as long as the vitamins and/or minerals meet specified limits on a per serving basis. JHNFA refers to the FNFC category as a "Standard Regulation System," in comparison to FOSHU, which is regarded as a "Product-based Approval System".
The FNFC health claims are in widespread use in Japan, although with unknown commercial success. It is not clear whether or not the use of the approved generic vitamin and mineral claims has resulted in increased product sales. The claims (i.e., vitamin C: "a nutrient which helps to maintain healthy skin and mucosa, and has an anti-oxidizing effect" for products with 24 mg to 1000 mg per serving) are not particularly exciting. The source of the vitamins and/or minerals in the products can be either from natural sources or fortification, which is a useful option.
These foods are regulated under the Health Promotion Law, and include both product-based approvals (for medical purposes) and standard foods. This was the original regulatory category that includes Foods for Medical Purposes, Foods for Pregnant Women, Foods for Infants, and Foods for the Elderly. The FOSHU category was added to this list of Foods for Dietary Uses at the time it was established. All of the products are allowed to use a special on-label mark (different from the FOSHU logo), identifying the product type. Low sodium soy sauces are included under these regulations, as well as hypoallergenic rice, which was moved from FOSHU to a Food for Medical Purposes designation several years ago.
In terms of on-label health claims for foods, the JHNFA describes all other types of foods as "unregulated," including the majority of health foods. This simply means that on-label health claims for all other foods are not legal in Japan. It is possible to use summaries of scientific findings as promotional materials, but these are being discouraged by MHLW. It is certainly the case that television promotion is being used, including testimonials from popular professors and medical doctors clearly designed to enhance the sales of certain products and ingredients. This practice is widespread, and is still being cited as the reason for the original cocoa "boom" in Japan several years ago, which eventually led to the development of the large cocoa polyphenol-rich chocolate market in Japan.
For health foods specifically, the Japan Health Food Association has developed, with industry involvement, relatively simple monographs for well over 50 popular health food ingredients, including safety and efficacy information. The latest monograph approved was for bilberries, a popular source of anthocyanins that most Japanese understand to have potential eye health benefits.
There is also encouragement from MHLW to certify facilities (or parts of facilities) with qualified organizations for GMP (Good Manufacturing Practices) compliance. JHNFA is one such organization involved in the certification process, and the Japan Institute for Health Food Standards is another.
It is worth mentioning briefly four other important regulatory areas with on-going activity related to foods. On May 29th, the Ministry began enforcing expanded regulations for agricultural chemical residues in foods and food ingredients. The BSE ("mad cow") import ban for U.S. beef is back in effect, pending clarification of new quality issues. For packaged food and beverage products, there are new developments in the Containers and Packaging Recycling Law to consider, as Japan continues to struggle with food packaging waste disposal. A planned 2007 Codex Alimentarius meeting to be held in Japan has begun to generate regulatory-related discussions, especially in terms of issues and opportunities that might eventually develop. The future promises to be interesting as well as challenging.NW
Note: Important sources of information for this article are Japan Health Food and Nutrition Food Association reference documents, the ifia Japan 2006 Guidebook, and the Japanscan Food Industry Bulletin published in the U.K.
About the author: Ron Bailey is president of California Functional Foods and has been an independent consultant for over 20 years, focusing primarily on the transfer of food technology between the U.S. and Japan. He can be reached at 165 Almond Street, Ashland, OR 97520; 541-488-3184; Fax: 541-488-3274; E-mail: bailey@mind.net.
The State of the FOSHU Market
Although the official report on the FOSHU market prepared by the Japan Health Food and Nutrition Food Association (JHNFA) indicates that FOSHU sales grew only 11% between 2003 and 2005, the opportunity for new FOSHU functional ingredients and products with new health claims remains strong. Truly new health claims are less common, however, in part related to the time and expense necessary to develop the clinical data in support of the claims being sought. Even though there were 171 new FOSHU product approvals during the past two years, most of the new products were formulated with previously approved functional ingredients (i.e., indigestible dextrin for intestinal health or blood glucose control).
In its official FOSHU summary, JHNFA does list 10 new "active" ingredients in FOSHU products approved in 2004 and 2005. There were five blood pressure control ingredients: wakame (a seaweed) peptide, nori (another seaweed) penta-peptide, sesame peptide, acetic acid and GABA (gamma-aminobutyric acid). LC1 lactic acid bacteria, bifidus Bb12 (Bifidobacterium lactis), and coffee bean manno-oligosaccharide (mannobiose) were approved as gut regulation active ingredients. Green tea fluoride for tooth health and a broccoli and cabbage-derived natural amino acid for cholesterol control were the final two new actives.
There are unofficial reports from Japan that a new FOSHU health claim category related to fatigue and/or stress is expected to be approved, perhaps by this time next year. A consortium of companies is generating the necessary supporting information for the new category, including development of appropriate biomarkers and analytical procedures, as well as possible claims and clinical study expectations. There are similar reports that the important weight loss/weight maintenance category will also gain FOSHU status over the next couple of years. If just these two new categories are accepted by the Ministry of Health, Labor and Welfare (MHLW), the FOSHU market potential will significantly increase, as each of the categories is already active in Japan in a non-FOSHU format.
At the same time, the FOSHU umbrella has expanded in other ways to allow a broader range of health claims in a modified format. These are referred to as the "New" FOSHU by JHNFA in its May 2006 publication entitled "Claims Regulation in Japan," defined as:
• Qualified Claims for FOSHU: no established evidence, but test results suggest evidence
• Standardized Claims for FOSHU: clinical trials necessary for safety only (limited to three dietary fibers and six oligosaccharides)
• Reduction of Disease Risk Claims for FOSHU: calcium and osteoporosis, folic acid and neural tube disease
Although there is interest in the qualified claims opportunity in particular, as it would seem to encourage the use of new "active" ingredients, in practice there are no marketed products using such qualified claims. Two new products have apparently been "approved," although it is not yet clear if the qualified claims permitted will be identified on the label as having come from the new regulatory process.
Foods With Nutrient Function Claims (FNFC)
This is the other formal category of foods with health claims in Japan that allows specific on-label claims, but in this case without the need for prior product approval by the Ministry. The category allows claims for 12 vitamins and five minerals, as long as the vitamins and/or minerals meet specified limits on a per serving basis. JHNFA refers to the FNFC category as a "Standard Regulation System," in comparison to FOSHU, which is regarded as a "Product-based Approval System".
The FNFC health claims are in widespread use in Japan, although with unknown commercial success. It is not clear whether or not the use of the approved generic vitamin and mineral claims has resulted in increased product sales. The claims (i.e., vitamin C: "a nutrient which helps to maintain healthy skin and mucosa, and has an anti-oxidizing effect" for products with 24 mg to 1000 mg per serving) are not particularly exciting. The source of the vitamins and/or minerals in the products can be either from natural sources or fortification, which is a useful option.
Foods for Special Dietary Uses
These foods are regulated under the Health Promotion Law, and include both product-based approvals (for medical purposes) and standard foods. This was the original regulatory category that includes Foods for Medical Purposes, Foods for Pregnant Women, Foods for Infants, and Foods for the Elderly. The FOSHU category was added to this list of Foods for Dietary Uses at the time it was established. All of the products are allowed to use a special on-label mark (different from the FOSHU logo), identifying the product type. Low sodium soy sauces are included under these regulations, as well as hypoallergenic rice, which was moved from FOSHU to a Food for Medical Purposes designation several years ago.
"Unregulated" With Respect to Health Claims
In terms of on-label health claims for foods, the JHNFA describes all other types of foods as "unregulated," including the majority of health foods. This simply means that on-label health claims for all other foods are not legal in Japan. It is possible to use summaries of scientific findings as promotional materials, but these are being discouraged by MHLW. It is certainly the case that television promotion is being used, including testimonials from popular professors and medical doctors clearly designed to enhance the sales of certain products and ingredients. This practice is widespread, and is still being cited as the reason for the original cocoa "boom" in Japan several years ago, which eventually led to the development of the large cocoa polyphenol-rich chocolate market in Japan.
For health foods specifically, the Japan Health Food Association has developed, with industry involvement, relatively simple monographs for well over 50 popular health food ingredients, including safety and efficacy information. The latest monograph approved was for bilberries, a popular source of anthocyanins that most Japanese understand to have potential eye health benefits.
There is also encouragement from MHLW to certify facilities (or parts of facilities) with qualified organizations for GMP (Good Manufacturing Practices) compliance. JHNFA is one such organization involved in the certification process, and the Japan Institute for Health Food Standards is another.
Other Regulations Impacting Functional Foods and Nutraceuticals
It is worth mentioning briefly four other important regulatory areas with on-going activity related to foods. On May 29th, the Ministry began enforcing expanded regulations for agricultural chemical residues in foods and food ingredients. The BSE ("mad cow") import ban for U.S. beef is back in effect, pending clarification of new quality issues. For packaged food and beverage products, there are new developments in the Containers and Packaging Recycling Law to consider, as Japan continues to struggle with food packaging waste disposal. A planned 2007 Codex Alimentarius meeting to be held in Japan has begun to generate regulatory-related discussions, especially in terms of issues and opportunities that might eventually develop. The future promises to be interesting as well as challenging.NW
Note: Important sources of information for this article are Japan Health Food and Nutrition Food Association reference documents, the ifia Japan 2006 Guidebook, and the Japanscan Food Industry Bulletin published in the U.K.
About the author: Ron Bailey is president of California Functional Foods and has been an independent consultant for over 20 years, focusing primarily on the transfer of food technology between the U.S. and Japan. He can be reached at 165 Almond Street, Ashland, OR 97520; 541-488-3184; Fax: 541-488-3274; E-mail: bailey@mind.net.
