\\Please tell us how the food for specified health use was born.
It is based on research results of a decade-long project sponsored by the former Ministry of Education.
Talking about the birth of Tokuho, first a project sponsored by the former Ministry of Education was initiated. From 1984 through 1986, led by Prof. T. Fujimaki, the former president of Ochanomizu University, studies of the effectiveness and functions of food were carried out in an organic and systematic way by researchers in the agricultural science and pharmaceutical sciences of universities and those of functional food throughout the country (the title of the research was "Systematic Analysis and Development of Functions of Food"). During these two years, a consensus was reached and a general notion of food was defined. That is, it has a nutritional function (the primary function), and two more functions in addition to the first one, such as taste function (or gourmet function, the secondary function) and the function of adjusting conditions of the human body (the third function). Later, from 1988 through 1990, special research entitled "Analysis of Functions for Adjusting Physical Conditions of the Human Body with Food" (the representative of the research group was Prof. H. Chiba) was conducted. While the research was being carried out, another study entitled "Analysis and Molecular Design of Functional Food" (the representative of the study was Prof. S. Arai) was performed from 1992 through 1994. As a result, these projects continued for about 10 years. During these research studies, the former Ministry of Health and Welfare announced its policy that functional food would be positioned as a product categorized under a law, in 1987.
In response to this movement, there emerged a boom in functional food around the same year. On that occasion, food of several kinds including health food and natural food also began to claim functions. This situation could lead to confusion for consumers. In order to avoid that situation, "Kinousei Shokuhin Konwakai" (in English, a group to discuss functional food) headed by Prof. T. Abe was set up in 1988, announcing a policy that only functional food with really excellent functions should be classed as functional food among all such food, taking the following circumstances into consideration. The number of people having life-style related illness has increased considerably. The reason for that would be that drugs have limitations. The functions of certain foods have already been sufficiently obvious that we should utilize them more. In that event, their effects had to be labelled more clearly, so that ordinary people would feel confident in using them and would not be misled. Thus, they reached the conclusion that setting up a system for proper labelling would be required.
The Kinousei Shokuhin Konwakai announced an interim report in 1989, which became the basis of the current Tokuho system. In 1991, the Tokuho system started. However, at that time, it was granted in a form of an addendum to the food for special dietary uses, which is for the use of parturient and nursing mothers, within the framework of the nutrition improvement regulation. If the name 'functional food' had remained as it was then, it would have been very helpful and convenient. However, its name has been determined as food for specified health use, which was unfamiliar to everyone. This name was very imprecise to consumers, so the food producers were very disappointed at its introduction.
\\The definition had been narrowed to be only "food explicitly recognizable as food." We heard that this was also another factor that deepened the disappointment of the companies involved.
Because of the limitation only to food, it resulted in a long-lasting inconsistency with the rules of overseas countries until very recently.
It certainly was, and was one of the reasons for that. The food is to adjust physical conditions through improving dietary habit, so it has to be easily used in dietary life. Of Tokuho, giving a reason has been done in this way. Due to the restriction that the food has to be appear to be in the form and state of food, it led to the consequence that the Japanese system until very recently was inconsistent with those of foreign countries.
There was also another reason, that is: for food for specified health use, effectiveness has to be unmistakably notified to consumers. In that event, there was a hurdle, namely, the matter of its connection with the Pharmaceutical Affairs Law, or how it was to be differentiated from medicines. Food manufacturers who are currently making applications for permission for food for specified health use are particularly concerned about how to stress the health claims of the food in question. When they do that, there is an obstacle, which is the so-called Notification 46, issued on the basis of the Pharmaceutical Affairs Law. The note lists many examples in detail, stating that some expressions belong to those for drugs. Thus, the legality for the food for specified health use could infringe that for medicines.
For Tokuho products, there has already been an answer that it is effective in health from the academic viewpoint. So manufacturers want to label health claims on their products, not nutritional claims. For food in general, two kinds of labelling are provided, namely, nutritional labelling and health labelling. The former has detailed labelling requirements of three kinds, i.e., ingredient labelling, labelling of comparison of contents (the amount of a certain component ingredient being a lot or a little, for example), and labelling of nutritional function. As for the last labelling, the former Ministry of Health and Welfare specified it in an obscure way when finalizing the standards for nutritional labelling. And now, a possibility of whether this functional labelling might be applied to dietary food supplements has begun to be sought instead.
With respect to ordinary food, the kinds of labelling permitted so far under the standard for nutritional labelling are ingredient labelling and content comparison labelling. It is only for food for specified health use or Tokuho that the use of health claims other than the listed labelling has been allowed. So Tokuho alone is allowed to claim health effects (which is defined as "Labelling of Health Care Application"). However, health labelling in Japan is mixed with that for nutrition. It differs from the health claims or health labelling emphasising health effects as used abroad. To put it squarely, the Japanese health claim provisions are lukewarm, and that is the current situation.
\\It has been said that there are now 171 items of specified health use food including yoghurt and beverages. Who are the people that can have the benefit of taking these products?
Concerning Tokuho, it undergoes human testing although the number of cases tested is fewer compared with that of pharmaceutical products. However, when looking at the test results, they have shown that physical conditions of the subjects became adjusted to the normal state in a relatively short time period.
Now, it has been said that three quarters of all adults are in a half-healthy state. The term adult disease has been changed to life-style related sickness. With unbalanced nutrition and a predisposing factor added on, such a state has generated a protracted custom. As a result, the circumstances led to irregular physical conditions, manifesting disease. This is life-style related illness. It would be possible to say that Tokuho is the food which rectifies the imbalance in nutrition. When too much of a certain nutrient component is taken, or fat intake is excessive, for instance, you might get hyperlipidaemia. If it is salt, you may become hypertensive. Contrary to this, if there is a shortage of some nutritional element , say iron intake is inadequate, you may become anaemic. Or you might get osteoporosis if the nutritient lacking is calcium. All these states and behaviours lead to life-style diseases.
It takes a period of about 10 years for a person to develop a life-style related illness due to unbalanced nutrition. The sickness manifests because of dietary life over the years. Conversely, if such a person was to correct the balance of nutrition from today, his symptoms would not improve as soon as tomorrow. If he rectified his nutitional intake, his physical condition would revert to normal over a period of 5 to 10 years. Speaking of Tokuho, test results demonstrated that physical conditions returned to normal in a relatively short time frame at least, although the number of people taking part in the trial was small. In other words, the functions of functional food did work. If we say it has a swift action, that might be an exaggeration. But it did have efficacy. In the case of Tokuho, it has undergone human testing. Whatever the scale of the test, that is, the number of the subjects for a test was either 20 or 30 people, the test was performed with half-healthy people as the principal subjects. So, of the specified health use food, it is more objective than health food, which has been given less scientific testing, in terms of number, than the former.
Some may ask to what extent the functions and effectiveness of Tokuho can be trusted. As I have explained, Tokuho does not conduct as many cases of human testing as pharmaceutical products. The latter are tested with sick people as the subjects, while the former is tested with half-health individuals as subjects. Making a comparison of Tokuho with other health foods, I think that it has its own scientific basis. Regarding evaluation systems of such functional food, operation of it in Japan is the strictest in the world. Raw data, as well as that on safety and stability, are required. In addition, Japan recently came to require test data for follow up even after granting approval. Food producers developing such food spend \5 million to \10 million or more for R & D on the food, taking at least one to two years time in order to obtain an official guarantee by the former Health and Welfare Ministry. I wonder why consumers do not take note of this point and use this benefit in a wiser way. Now, Tokuho products that can deal with life-style disease are becoming available.
Japan was the first to start this Tokuho system, which is followed by the U.K., Sweden, and China, all of who are making preparations for instituting the system. In 1995 through 1996, investigating teams visited us every month, one after another from all over the world, saying that they wanted data relevant to Tokuho. Countries who plan to provide regulations of food which claim health effects use the Japanese Tokuho system as a model or draft to a greater or lesser extent.
\\Please tell us about the future prospects for Tokuho products.
The problems are that its recognition in society is still low, and that doctors and nutritionists have only a superficial understanding of it.
The Tokuho system was established in 1991, having a recognition rate now of around 20%. It is said that those who really understand and utilize Tokuho are about 15%, while those who have an interest in the heath claims are approximately 35%. It has been eight years since the establishment of the system, but recognition is still low. Its market size is estimated to be in the range of an annual turnover of \200 billion.
Tokuho system was initiated in Japan, being set as the example all over the world, and it would not disappear. Rather, I think that Japan is in a position to lead and further develop the system. In future, the failure of our medical administration system will become more serious as ageing of society progresses. It will be necessary to modify the form and state of the food in such a way that would be of help to alternative medicine. The current issues are that its social recognition is still low, and that recognition by medical service providers and dieticians is also low. In addition, from the academic viewpoint, the basis of the relevant systems such as clinical dietetics is not adequately provided. So an issue also arises of how these gaps are to be narrowed.
As for how the Tokuho system should be, there used to be days in which there was divergence of views, namely, whether it had to advance as a Japan only system, or had to be consistent with systems of other countries. Now the issue with the most importance is about its state and forms. It has health effects close to those of pharmaceutical products although its state and shape is food. There are so-called nutritional supplements and health food, both of which are prepared in the form of either tablet or capsule. This situation could give rise to confusion among consumers, that is, which one is the most effective. The forms and states of all these products might be fused and integrated. This may happen some time in the future.