| 1. |
What is FOSHU?
The Ministry of Health, Labor and Welfare (MHLW) defines Food for Specified Health Uses (FOSHU) on its website as follows: “FOSHU refers to foods containing ingredient with functions for health and officially approved to claim its physiological effects on the human body. FOSHU is intended to be consumed for the maintenance/promotion of health or special health uses by people who wish to control their health condition.” To put it simply, FOSHU is a food product with a health function substantiated by scientific evidence, such as “regulating intestinal conditions,” “reducing cholesterol absorption” or “preventing tooth decay,” and is approved by the MHLW to carry such health claim.
From 2004 to 2005, the MHLW approved 171 food items for marketing as FOSHU products, of which 94 were approved in 2005 alone, marking a record number of annual FOSHU approvals. As of the end of December 2005, the total number of FUSHO approvals amounted to 569 food items (755 items as of December 19, 2007)
<Data 1: Trends in annual FOSHU approvals>
Source: the Japan Health Food & Nutrition Food Association
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| 2. |
<Data 2: Constituent ratio of death cause>
Source: 2006 vital statistics by the MHLW |
Background
Behind the growing demand for FOSHU products are the increasing numbers of people with lifestyle-related illnesses that have increased consumer interested in health foods, as well as high consumer confidence in the efficacy of FOSHU. In Japan, deaths from lifestyle-related illnesses now account for about 60% of all deaths, lifting national medical treatment costs for such illnesses to more than 30% of the total. Growing concern about metabolic syndrome, which has become a buzzword in recent years, is also encouraging consumers to purchase more health foods. Among such foods, FOSHU products carry a health claim approved by the MHLW, which makes consumers feel safe in buying the products. The FOSHU system was first introduced in Japan; countries in Europe and North
America are now making preparations for instituting a similar system based on this revolutionary approach.
In Japan, before the introduction of the FOSHU system, what consumers put into their mouths was grouped into only two categories: foods and pharmaceuticals. So-called health foods were classified as food and were not allowed to carry health claims. Consumers had no idea what functions health foods had. Moreover, a series of health hazards and violations of the Pharmaceutical Laws was reported. To rectify the situation, the FOSHU system was introduced. As shown in the table below (Data 3), food products are now grouped into three categories: 1. Food for Specified Health Uses (FOSHU); 2. Food with Nutrient Function Claims (FNFC); and 3. Common foods (including health foods). Foods that fall under categories 1 and 2 are collectively called Food with Health Claims (FHC); the others are categorized as common food (health food) of category 3. Selling a food as FOSHU requires carrying an approved health claim (Data 4) and an authorized FOSHU seal (Data 5).
<Data 3: Classification of pharmaceuticals and foods>
|
Pharmaceutical |
Quasi-drug |
Food for specified health uses (FOSHU) |
Food with nutrient function claims (FNFC) |
Common food
(inc. health food) |
| Regulated by |
Pharmaceutical Affairs Law |
Health Promotion Law/Food Hygiene Law |
No law |
| Function claim |
Authorized to carry health claim
approved by MHLW |
Authorized to carry designated
nutritional claim only |
Not authorized (Claim labeling is illegal.) |
| Sales regulation |
Sold at drug stores only
(some exceptions) |
Sold at general merchandise stores |
|
<Data 4: Major health claims (examples) currently approved by the MHLW & health functional substances>
| Health claim |
Health functional substances (influential components） |
| Foods for regulating intestinal conditions |
Fructo oligosaccharide, galactooligosaccharide, lactulose, polydextrose, indigestible dextrin, guar gum, psyllium seedcoat-derived dietary fiber, bifidobacteria etc. |
| Foods for reducing high blood pressure |
Lactotripeptide, casein dodecapeptide, tochu leaf glycoside, sardine peptide |
| Foods for reducing high blood cholesterol |
Soybean protein, chitosan, degraded sodium alginate, phytosterol |
| Foods for improving blood sugar control |
Indigestible dextrin, wheat albumin, guava tea polyphenol, L-arabinose |
| Foods for improving mineral absorption |
CCM (calcium citrate malate), CPP (casein phosphopeptide), hem iron, fructo oligosaccharide |
| Foods for decreasing natural fat in blood after meal |
Diacylglycerol, globin protein degradation product |
| Foods for preventing causes of tooth decay |
Paratinose, maltitol, xylitol, erythrytol, tea polyphenol |
| Foods for maintaining dental health |
Xylitol, reduced palatinose, Dicalcium Phosphate, fukuronori extract, CPP-ACP (casein phosphopeptide-amorphous calcium phosphate) |
| Foods for reducing absorption of fat into body |
Diacylglycerol |
| Foods for improving bone health |
Vitamin K2, soybean isoflavone |
|
<Data 5: Example package label>
| FOSHU package label (example) |
| * |
Food with health claims(Food for specified health uses) |
|
Trade name: XX |
|
Product name: XX processed food |
| * |
Ingredients: XX, XX, … XX
Best before date: See XX |
|
Volume of content: XX gram |
|
 |
| * |
Approved health claim: XX, containing XXX, can readily increase the intake of dietary fiber, which is often lacking in the typical diet and improves bowel movements. |
| * |
Nutrition facts/calories: per bag
Calories XX kcal; protein XX g;
fat XX g; carbohydrate XX g; sodium XX g;
functional substance XXX (XX g) |
| * |
Recommended daily intake: 2 bags per day |
| * |
Directions: Mix with water and stir well |
| * |
Safety precautions: Excessive intake can cause loose bowels. Please observe the daily intake. |
| * |
Handling & storage: Keep in cool place, away from direct sunlight |
| * |
Distributed by: XXX (company name) XXX (address) |
(Note) Daily nutrient adequacy: XX%
(If functional substances have specified daily nutrient requirement) |
|
|
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| 3. |
<Data 6: Trends in FOSHU market development>
Source: the Japan Health Food & Nutrition Food Association |
FOSHU market
The FOSHU market has been steadily expanding, although its growth has slowed recently. According to a survey conducted by the Japan Health Food & Nutrition Food Association, the FOSHU market amounted to 630 billion yen in 2005 (manufacturer’s suggested retail price base), an increase of 11.1%, or 63 billion yen, from 2003. The market has expanded fivefold from the 131.5 billion yen of the 1997 first survey.
Growth trends by health function in Data 7 show that intestinal regulation-related products are growing less fast, but are still playing a leading role in the FOSHU market, with approximately 59% of the total market share. Of those products, the lactobacillus-containing products have a high market share of approximately 56% or 351.6 billion yen. The products for modifying cholesterol, blood pressure, neutral fat and body fat levels, all closely related to lifestyle-related illnesses, are steadily expanding their market shares, which in the neutral fat/body fat-related, blood pressure-related and cholesterol-related products have increased by 38.6%, 67.7% and 100.7%, respectively, since 2003. These figures reflect the steady expansion of the FOSHU market, although the growth of intestinal regulation-related products is sluggish. The tooth-related products, focusing on chewing gum, have the second largest market share - of 96.1 billion yen - after the intestinal regulation-related products. Because of growing concern about metabolic syndrome, in 2006 demand began increasing for products that help control neutral fat levels. Presumably, this trend continues in 2007, even though exact numbers for the year have not yet been released.
<Data 7: Growth trends by health function> FY>
| FY |
1997 |
1999 |
2001 |
2003 |
2005 |
| \100 mil. |
\100 mil. |
Change from 1997(％) |
\100 mil. |
Change from 1999(％) |
\100 mil. |
Change from 2001(％) |
\100 mil. |
Change from 2003(％) |
| Intestinal regulation |
Oligosaccharide |
103.7 |
91.1 |
87.9 |
56.2 |
61.7 |
66.8 |
118.9 |
58.9 |
88.2 |
| Lactobacillus |
978.8 |
1,863.0 |
190.3 |
3,171.1 |
170.2 |
3,420.8 |
107.9 |
3,516.8 |
102.8 |
| Dietary fiber |
119.1 |
115.5 |
97.0 |
128.1 |
110.9 |
141.8 |
110.7 |
129.9 |
91.6 |
| Subtotal |
1201.6 |
2,069.6 |
172.2 |
3,355.4 |
162.1 |
3,629.4 |
108.2 |
3,705.6 |
102.1 |
| Cholesterol |
0.3 |
4.3 |
1,433.3 |
27.9 |
648.8 |
113.6 |
407.2 |
228.0 |
200.7 |
| Blood pressure |
13.8 |
71.6 |
518.8 |
100.0 |
139.7 |
88.1 |
88.1 |
147.7 |
167.7 |
| Bone/mineral |
92 |
44.9 |
48.8 |
113.9 |
253.7 |
120.1 |
105.4 |
143.3 |
119.3 |
| Tooth |
0 |
3.7 |
- |
186.7 |
5,045.9 |
804.8 |
431.1 |
961.0 |
119.4 |
| Blood sugar level |
6.7 |
5.2 |
77.6 |
184.3 |
3,544.2 |
277.4 |
150.5 |
232.9 |
84.0 |
| Neutral fat/body fat |
0 |
70.0 |
- |
152.4 |
217.7 |
635.4 |
416.9 |
880.7 |
138.6 |
| Total |
1314.5 |
2,269.3 |
172.6 |
4,120.6 |
181.6 |
5,688.8 |
137.6 |
6,299.2 |
111.1 |
|
Source: the Japan Health Food & Nutrition Food Association
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| 4. |
Future prospects
As previously mentioned, the FOSHU market is growing less fast, although it has been expanding. FOSHU products cost manufacturers a substantial amount of development expenses, and market competition has intensified. However, Japan is expected to face an increasingly aging population, as well as growing national medical expenditure, especially for lifestyle-related illnesses. Moreover, “the specified health checkup/health guidance system,” focusing on prevention of metabolic syndrome, is to start in fiscal 2008. Amid the growing concern about disease prevention to moderate national health care expenditure, it is considered that FOSHU products, which fall somewhere between drug and food, can meet such social needs. Demand for the FOSHU products, especially those preventing metabolic syndrome, is therefore expected to grow further. |
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