Do the Japanese Regulations Restrict Freedom of Speech?

By Paul Yamaguchi

FOSHU Regulates What Health Claims Can Be Printed On Food Labels

Freedom of speech has its limits in our industry. The government must approve all health claims printed on food labels. The Japanese government recognized the need to regulate food labels early on so that consumers choose the right foods to maintain their daily health.

In the last issue I mentioned there are two types of regulations for health claims in Japan. One is a product-based (not ingredient-based, as some people believe) approval called FOSHU. FOSHU is 12 years old; just last month it celebrated the 10-year anniversary of its first product approval in Tokyo. After 12 years, the number of approved products has grown to over 390 and the market for these products is $4.1 billion - 32 percent of the total Japanese functional food market.

Standard Health Claims Also Regulate What Can Be Printed On Food Labels

Foods with Nutrient Function Claims (FNFC), or Eiyo Kino Shokuhin in Japanese, is just 2 years old. FNFC describes a standard health claim, that is, the relationship between a nutrient and its health benefit. Japan’s Ministry of Health, Labor and Welfare (MHLW) sets the standard list of nutrients and their associated health benefits. If a product contains the approved nutrient in amounts within the established guideline , then specific nutrient-based functional claims are allowed on the food label. In addition to the nutrient-based functional claims, the product labels are required to show daily intake guidelines, storage methods and other precautionary statements.

FNFC is voluntary and no evaluation or approval is necessary by the MHLW. Unlike FOSHU, no symbol or mark has been created. There are hundreds of products that qualify for FNFC, and there is no official count of the products or market volume that has yet been published. We estimate that there are over 1,000 FNFC products on the market with a market size of over $5 billion.

More to Come

So far 12 vitamins and 2 minerals are recognized on the FNFC list of approved nutrients. (See the nutrients and their nutrient functional claims below.) MHLW is considering recognizing other nutrients, including vitamin K, phosphorous, magnesium, potassium, copper, zinc and 8 other nutrients in the future.

What is declared on a label is always a controversial subject. Maximum expression within restrictive guidelines is the nature of this business. Both good scientists as well as excellent copywriters are critical in order to succeed in this business.

FNFC’s Authorized Nutrients and Functional Claims.

Nutrient Maximum content Minimum content

Vitamin A: 2,000IU 600 IU

Nutrient Function Claim: Vitamin A helps maintain vision at night. Vitamin A helps maintain healthy skin and mucosal membranes.

Vitamin B-1 25 mg 0.3 mg

Nutrient Function Claim: Vitamin B-1 helps produce energy from carbohydrate and helps maintain healthy skin and mucosal membranes.

Vitamin B-2 12 mg 0.4 mg

Nutrient Function Claim: Vitamin B-2helps maintain healthy skin and mucosal membranes.

Vitamin B-6 10 mg 0.5 mg

Nutrient Function Claim: Vitamin B-6 helps produce energy from protein and maintain healthy skin and mucosal membranes.

Vitamin B-12 60 mg 0.80 mg

Nutrient Function Claim: Vitamin B-12 aids in red blood cell formation.

Vitamin C 1000 mg 30 mg

Nutrient Function Claim: Vitamin C helps to maintain healthy skin and mucosal membranes and has antioxidant benefit.

Vitamin D 200 IU 35 IU

Nutrient Function Claim: Vitamin D promotes absorption of calcium in the intestines and helps development of bone.

Vitamin E 150 mg 3 mg

Nutrient Function Claim: Vitamin E helps protect oxidation of fat in the body and helps maintain healthy cells.

Niacin 15 mg 5 mg

Nutrient Function Claim: Niacin helps maintain healthy skin and mucosal membranes.

Biotin 500 mg 10 mg

Nutrient Function Claim: Biotin helps maintain healthy skin and mucosal membranes.

Pantothenic acid 30 mg 2 mg

Nutrient Function Claim: Pantothenic acid helps maintain healthy skin and mucosal membranes.

Folic acid 200 mg 70 mg

Nutrient Function Claim: Folic acid aids in red blood cell formation. Folic acid contributes to the normal growth of a fetus.

Calcium 600 mg 250 mg

Nutrient Function Claim: Calcium is necessary in the development of bone and teeth.

Iron 10 mg 4 mg

Nutrient Function Claim: Iron is necessary for red blood cell formation.

I’ll talk more about the current nutraceutical environment in the next issue.

Stay tuned.


Paul Yamaguchi is president of Paul Yamaguchi & Associates, Inc., Tarrytown, NY.

His company publishes a number of Japanese nutrition market reports, including Nutraceutical Japan 2003, Nutritional Supplement Japan 2003, Functional Foods and FOSHU (Foods for Specified Health Use) Japan 2003. For details and information on the reports, visit: www.functionalfoodsjapan.com or contact Paul at [email protected]

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