Japanese History of Probiotic & Prebiotic Development
The Yakult Honsha Company is generally credited with introducing the first branded probiotic in Japan well over 70 years ago. The term “probiotic” had not yet been developed, but the “Yakult” lactic acid beverage became the standard for the category. Yakult’s probiotic bacteria strain, Lactobacillus casei Shirota, served as the scientific base for the brand. According to a recent Yakult company profile, over 25 million people in 26 countries now consume Yakult every day.
The development of the prebiotic market in Japan started with the recognition that the “friendly” bifidobacteria probiotics in particular required special nutrient sources in the gut to survive and thrive. Originally these nutrients were referred to as “bifidus factors” in Japan, since much of the early focus was on the various strains of bifidobacteria. The Japan Bifidus Foundation was formed in 1981 to support serious research on these pre- and probiotics. Morinaga claims to have introduced the first bifidus product in Japan in 1977, a fermented milk with Bifidobacteria longum. Yakult followed in 1978 with a bifidus yogurt containing Bifidus breve, Bifidus bifidum, and Lactobacillus acidophilus.
Meiji Seika developed the first commercial “bifidus factor” ingredient for sale in 1984—a fructooligosaccharide (FOS) prebiotic to enhance the growth of bifidobacteria in the human gastrointestinal tract.
It is worth noting that during development in Japan, U.S. mainstream food companies, including at least some in the yogurt business, were skeptical that U.S. consumers would accept the concept of consuming live bacteria for potential health benefits. At the time, the idea that there could be “friendly” bacteria helpful in controlling harmful bacteria in the gut was certainly not mainstream thinking.
Incentives for Pre/Probiotic Market Development
In typical Japanese fashion, development of these new pre- and probiotic ingredients and finished products was based on sound science and supported by demonstrated Japanese health needs.
Health Incentive. The health incentive was related to the understanding that stomach cancer death rates in Japan (over 50,000 deaths in 2004) are much higher than in the rest of the world. The Japanese rate of 51.2 deaths per 100,000 people can be compared with data from the U.S. (5.3) and Mexico (5.4). In addition, there were another 40,000 deaths related to other diseases of the digestive system, including 3400 from gastric and duodenal ulcers. There also were over 1600 reported food poisoning incidents and five deaths in Japan in 2004, with 70% of those bacteria-related. Japanese consumers are well informed about these gastrointestinal health issues.
Regulatory Incentive. The Japanese Ministry of Health, Labor, and Welfare (MHLW) gather data on health in Japan, and are aware of the human and financial consequences of not adequately addressing the leading health issues. That was the incentive for the development of the Foods for Specified Health Uses (FOSHU, “Tokuho” in Japanese) regulatory category in the late 1980s.
Interestingly, the first approved FOSHU gastrointestinal health products were not probiotics, but rather prebiotic oligosaccharides. Suntory was granted approval in October 1993 for its “Yogurina” lactic acid bacteria drink with xylo-oligosaccharide as the functional ingredient. The on-label claim: “This drink acts to increase intestinal Bifidobacteria and maintain a good gastrointestinal condition.” During the same period, Calpis Food Industry was granted approval for its FOSHU “Oligo CC” carbonated beverage with soybean oligosaccharide, which carried a very similar claim.
The first FOSHU probiotic drink was not approved until May 1996. This yogurt drink, from Takanashi Milk products, contained Lactobacillus GG “to help increase intestinal Bifidobacteria and Lactobacilli and regulate GI condition.” This was followed in November 1996 by the simultaneous approval of two very popular yogurt brands that had been marketed for several years. Morinaga’s “Bifidus Plain Yoghurt” with Bifidobacterium longum BB536 and Meiji Milk Products’ (now Meiji Dairies) “Meiji Bulgaria Yoghurt LB 81” with Lactobacillus delbreukii and Streptococcus salivarius 1131 were allowed to make similar GI claims with references to the specific strain(s) of bacteria used as the functional ingredient(s). This strain-specific approach has become the standard for FOSHU approvals.
The conversion of these popular yogurts to FOSHU status instantly added several hundred million dollars of sales to the already-growing FOSHU regulatory category. The conversion also helped increase consumer awareness of FOSHU. Major FOSHU sales growth also occurred in 1998 and 1999 when almost the entire line of Yakult brands, including their flagship “Yakult” beverage, converted to FOSHU status. All of the Yakult products approved at that time were based on the L. casei Shirota probiotic strain that had been developed nearly 70 years earlier.
Prebiotic & Probiotic Health Claim Extensions
It is generally agreed in Japan that the market for FOSHU products with gastrointestinal health claims is approaching saturation. Official April 2006 published data from the Japan Health Food and Nutrition Food Association (JHNFA) indicated that 44% of the 583 products approved at that time were focused on gastrointestinal health, primarily probiotics and prebiotics to “help maintain good gastro-intestinal condition.” These products represented nearly $3.6 billion in 2005 sales, but growth has slowed and their percentage of total FOSHU sales has declined. This trend is expected to continue.
In an attempt to stimulate sales, interesting new claims are also now being used in approved FOSHU pre- and probiotic products. These include prebiotic indigestible dextrin dietary fiber to “moderate the absorption of sugar,” for example, and fructooligosaccharide to “increase the rate of calcium absorption … suitable for making strong bones.” More recent probiotic claims include Nestlé Japan’s “LC1” lactic acid bacteria drink claim related to reducing pathogenic bacteria in the gut.There are many non-FOSHU pre- and probiotic products being marketed in Japan with at least implied and/or off-label claims focused on important health issues. These include red cedar pollen allergy, H. pylori bacteria colonization in the stomach, and immune function enhancement. Cancer prevention and suppression is being researched with some encouraging developments, but is necessarily a long-term project. The positive safety and efficacy experience with the probiotic and prebiotic ingredients in Japan is important in helping establish credibility for the new claim developments. MHLW has a stake in allowing such developments to proceed, but is expected to maintain a relatively cautious and conservative approach to new approvals.
Part of the message intended in this brief article is to suggest that the longer-term Japanese approach to new food and beverage product and ingredient development is a useful model for consideration elsewhere. Japan’s rapidly aging population must be kept as healthy as possible, so its first step typically has been to define the relative magnitude of the health issues. The data, ingredients and products developed to support Japanese health needs are likely to be relevant to other countries with aging populations, including the U.S.
Government support for new regulatory initiatives is essential. It is not too early for overseas companies to begin to consider the Japanese approach to specific health conditions as a framework for developments outside Japan.NW