JAPANESE FUNCTIONAL FOODS: TOKUHO SYSTEM

17.3 JAPANESE FUNCTIONAL FOODS: TOKUHO SYSTEM

One of the very first functional foods in Japan was dietary fiber in the form of a soft drink called Fiber-Mini. The drink, which used water-soluble polydextrose as

its functional ingredients and claimed to improve “gut’s regulation,” was launched in 1980 by Otsuka Pharmaceutical. The marketing success of this product led to a high demand for drinks with high levels of fiber and the start of the functional foods regulatory system in Japan. 9

The concept of functional foods and food functions has been extensively studied under the sponsorship of Japanese government. Two years of studies (1984 to 1986) on “systematic analysis and development of functions of food” followed by studies (1988 to 1990) on “analysis of functions for adjusting physical conditions of the human body with food” led to the identification of the tertiary function of foods, which, unlike the conventional (primary, nutrition; secondary, taste) functions, is directly involved in the modulation of human physiological systems such as the

immune and digestive. 10 It has become clear that food can be designed not only to satisfy primary functions, but also for adjusting conditions of the human body’s function. The concept of physiologically functional foods (functional foods) was thus born and consequently led to the creation of the Japanese regulatory system of this category of foods. In 1993, the Ministry of Health and Welfare established a policy to regulate Foods for Specified Health Use (FOSHU), or Tokuho in its Japanese abbreviation. Under this system, the use of health claims for some selected functional foods is legally permitted. 11

Unlike in Canada and some other countries, the Japanese definition for food — “foods are processed containing ingredients that aid specific bodily functions in

Food Regulations

addition to being nutrition” — allows the Japanese to use health claims, which in other countries would be allowed only for drugs.

Under the Japanese Nutrition Improvement Law, there are five categories of Foods for Specified Health Use: 11

1. Foods for the ill

2. Milk powder for pregnant or lactating women

3. Formulated milk powder for infants

4. Foods for the aged

5. Foods for Specified Health Use (FOSHU) FOSHU is the largest food group in Japan with health claims. As of October

2003, there were 398 foods approved under the FOSHU regulations. 12 Functional carbohydrates represent a significant portion of bioactive components of FOSHU

(Table 17.1). Specifically, oligosaccharides and indigestible starch are functional ingredients of prebiotic and synbiotic foods to “help maintain good gastro-intestinal

condition.” Dietary fiber is used widely in FOSHU foods to “help improve bowel movements” and “maintain a healthy cholesterol level.” It is also considered to be

good for those who have “mildly higher blood glucose.”

A group of fructooligosaccharides (FOSs) is an example of a dietary fiber that has been approved under the FOSHU regulations for use in a wide range of functional

foods. Two different classes of FOS mixtures are produced commercially, based on inulin degradation or transfructosylation processes. In Japan, FOS is produced through the transfructosylating action of β-fructofuranosidases of Aspergillus niger on sucrose. This class of FOS is manufactured by Meiji Seika Kaisha Ltd. and marketed as Meioligo, Neosugar, Profeed, Actilight, or Nutraflora. 13

Meioligo is used as a prebiotic, sweetening agent, flavor enhancer, and bulking agent. As a prebiotic, Meioligo is used in functional dairy drinks (prebiotics, syn-

biotics) to promote the growth of beneficial bacteria in the gastrointestinal tract. Because FOS molecules are not digested and thus not absorbed in the upper part of

the gastrointestinal tract (or if absorbed, the quantity is negligible), they arrive unchanged to the colon, where the beneficial bacteria, most notably the bifidobac-

teria, utilize them as select food for growth and proliferation. Meioligo is also used as a low-calorie sucrose replacement in products for diabetics, such as cookies,

cakes, breads, candies, table sugar, dairy products, and some beverages. 14 The approval of FOSs in Japan prompted the establishment of an acceptable daily intake of about 0.8 g/kg of body weight/day.

In addition to FOSs, there are a number of other oligosaccharides that are approved under the FOSHU for use as prebiotics. This list includes soy-oligosac- charides, galacto-, xylo-, and isomalto-oligosaccharides, as well as lactosucrose used in “one-a-night plain” soft drink. FOSHU approved dietary fiber includes polydex- trose, indigestible dextrin, wheat bran, partially depolymerized guarana, and a psyl- lium seed coat. Chitosan is another example of functional carbohydrates bearing the FOSHU approval. This is a nondietary fiber that is extracted from the shell of crustaceans, such as crab and shrimp. Food products containing chitosan gain pop- ularity among Japanese consumers for their ability to prevent fat absorption and

Functional Food Carbohydrates

TABLE 17.1 Approved Foods for Specified Health Use as of October 2003 12

Number of FOSHU in a Specific

Percentage of Health Claims Permitted

Functional Ingredients

Category Total FOSHU

Helps maintain good gastro- Dietary fiber, oligosaccharides, 196 49% intestinal condition

indigestible starch,

Helps improve bowel

lactobacillus, bifidobacterium

movement Helps prevent from

66 17% accumulation of body fat

Dietary fiber, soy protein,

peptides, diacylglycerol, plant

Good for those who have

sterols/stanols esters, medium-

higher serum

chain triglycerides, tea

cholesterol/triglycerides

catechins, EPA/DHA

Good for those who have

49 12% mildly higher blood

Dietary fiber, albumin,

polyphenols, L-arabinose

glucose Good for those who have

38 10% mildly higher blood

Peptides (Lacto-Tri, sardine,

bonito, casein), tea glucosides,

pressure

isoleucyltyrosine

Helps maintain strong and

26 7% healthy teeth

Xylitol, polyols, tea

polyphenols, CPP-ACP, Pos-

Ca

May restrain mineralization

and helps promote re- mineralization

Helps improve absorption

23 6% of calcium

CPP, CCM, soy isoflavanoids,

MBP, polyglutamin acid, V.K2,

Good for those who have

heme iron

mild anemia

Total

weight gain. Recently, Nissin Oil Mills Ltd. introduced an instant cup of noodle soup to the Japanese market that contains chitosan as the functional ingredient. This product bears the following health label: “Chitosan has the effect of inhibiting absorption of cholesterol and lowering blood cholesterol.” 15

The FOSHU approval process is quite complex and typically takes at least 1 year to complete. Although the Ministry of Health, Labour and Welfare (MHLW) is technically responsible for supervising the FOSHU process, the Japan Health Food and Nutritional Association (JHFNA), a private organization, actually administers the process. Subsequently, the applicant needs to consult JHNFA to review an application prior to submission to the local prefectural health authorities and MHLW. The application must contain scientific evidence (e.g., results of clinical studies) of the ingredient’s efficacy and safety, physical and chemical characteristics, compo- sitional analysis, and relevant analytical methods, as well as the basis for the rec- ommended dose that will provide the efficacy from the ingredient. The application

Food Regulations

TABLE 17.2 Information and Documentation Required in FOSHU Application 12

1. Sample of the entire package with labels and claims for which approval is sought 2. Explanation of how the food contributes to the improvement, maintenance, or enhancement

of human health 3. Recommended daily intake of the product and its functional components 4. Documentation that shows clinical and nutritional proof of the product’s efficacy within

recommended daily intake: 1) In vitro and in vivo animal studies explaining the effects, mechanisms of action, and metabolism and pharmacokinetics (absorption, distribution, metabolism, and excretion) on the constituents concerned, results of which should be statistically significant

2) Clinical studies using the food applied and confirming the specified health effects and the recommended daily intake, results of which should be statistically significant

3) Randomized, double-blind, controlled clinical study using local subjects may be required 5. Documentation demonstrating the safety of the food and its constituents: 1) In vitro and in vivo animal studies confirming basic information on the limits of safe intake 2) Clinical studies confirming the safety in the case of excessive consumption 3) 3 to 5 times higher level of recommended daily intake of the food or its constituents

concerned 6. Documentation on the stability of the food and its constituents 7. Documentation of the physicochemical properties of the food’s constituents concerned, and

description of the analytic methods used:

1) The identification of the food’s constituents in question may be required 8. Results of qualitative and quantitative determination of the food’s constituents concerned, and description of the analytic methods used 9. Results of tests determining the constituents concerned and nutrients, and energy value of the food 10. Description of the quality control system explaining the facilities, equipment, and production methods used in manufacturing the food

must be accompanied by scientific publications in relevant peer-reviewed journals showing results to substantiate the health claim. After regulatory review, the approved

foods are eligible to carry a label indicating the specified health benefit. The approval of the MHLW must also be displayed on the label of FOSHU food products. The

documentation required for FOSHU approval is listed in Table 17.2. 12 It is important to emphasize that the FOSHU approval process is voluntary, and approved products represent a small portion of the Japanese health food market. Nonapproved FOSHU functional foods, many of which contain approved functional components, are sold legally on the Japanese market without specific health claims.

A lot of manufacturers sell functional foods as non-FOSHU products to avoid rather cumbersome, lengthy, and very expensive approval processes. In addition, many companies prefer to conduct market assessment for specific products before applying for the FOSHU approval. In 2003, FOSHU products accounted for about U.S.$4.1 billion of the total health food market, while other, non-health-claim functional foods represented the largest portion of the sector at an estimated U.S.$8 billion. 16

Functional Food Carbohydrates