The Inventor of Functional Foods

Regulatory Requirements
Japan—The Inventor of Functional Foods
        Regulatory Requirements
        Marketplace Implications and Consumer Impact
United States—A Good System Gone Bad
United Kingdom—Chaos Reigns Supreme

A.  Food for Specified Health Use Requirements

Functional foods are now a distinct category within the Japanese food supply. They are distinguished from foods simply fortified with vitamins or minerals and from dietary supplements sold in pill or capsule form that are marketed as aids to ensure increased intakes of such nutrients. Under this system, the term “functional” was actually dropped and the term “Foods for Specified Health Use,” or “FOSHU,” was introduced.

The FOSHU system is unique because it focuses on health claims for specific products. Approved products are permitted to make express health claims on product labels. An example is Tochu 120, an infusion of tochu leaves manufactured by Hitachi Zosen Co. which gained FOSHU approval in 1996. The label states “This drink contains an infusion of tochu leaves. This food is suitable for high blood pressure.” Another required label statement, however, attempts to distinguish the product from a drug. It reads: “This product does not prevent or cure hypertension.”

In order for a product to be approved as FOSHU, companies need to go through an application process that typically takes about one year to complete (Table 2). Applications are reviewed by local prefecture authorities and the Ministry of Health and Welfare (MHW). Applications must include scientific documentation demonstrating the medical or nutritional basis for a health claim, the basis for the recommended dose of the functional ingredient, information demonstrating the safety of the ingredient, information on physical and chemical characteristics, relevant test methods, and a compositional analysis. This information is expected to be accompanied by scientific papers in the fields of medicine and/or nutrition that substantiate the health claim.

The labels of FOSHU products must include: the approved health claim; recommended daily intake of the food; nutrition information; guidance on healthy eating; a warning against excessive intake, if necessary; any other special precautions relating to intake, preparation or storage; and other information (Table 3).(6) The law contains a general prohibition against including any misleading information on labels. That prohibition also applies to advertising. Domestic products carry an “Approved” mark from the MHW, while imported products carry a “Permitted” mark.

FOSHU foods carry a mark from the Ministry of Health and Welfare.

B.  “Health Foods” Are Unregulated

The approval system, however, remains voluntary. Companies can market so-called “health foods” without obtaining FOSHU approval as long as they refrain from making express claims that the product can reduce the risk of a disease or health-related condition. For example, the label of VegitaBeta (a sugar-water beverage containing small amounts of vegetable juice and added beta-carotene) is loaded with pictures of vegetables and fruits and states that the product is a “health supporting drink.” While the label does not expressly mention any disease, it plays upon consumer awareness of preliminary scientific studies — now refuted — that once linked beta-carotene supplementation with a reduced risk of cancer. This is one of the greatest weaknesses of the Japanese system. From 1991 to 1998, only 126 products received FOSHU approval (Table 4). In 1997, those products represented about 130-billion Yen in sales (about US$1 billion dollars).(7) However, approximately one thousand other functional foods have been introduced into the Japanese marketplace as health foods. Although there are no firm data on the size of the total health food market in Japan,(8) FOSHU-approved foods are estimated to represent only about 15% of the total.(9)

To increase voluntary participation in the FOSHU approval system, the government recently made several significant changes to the application procedure. First, the amount of scientific documentation that manufacturers must submit has been reduced. In the past, applications often totaled 1,000 pages or more.(10) Large volumes of supporting scientific documents are no longer required.

Second, originally, manufacturers had to submit a certificate that all submitted scientific documentation had been reviewed by outside scientific experts. That requirement has now been eliminated and replaced by a requirement that studies be published in a scientific journal. An industry-sponsored journal has been deemed acceptable by the MHW.

Third, the government eliminated a requirement that products be tested by the National Health and Nutrition Laboratory. Now, the manufacturer's own analytical tests are accepted by the MHW. In addition, much of the responsibility for reviewing applications has been turned over by the Ministry to local prefecture authorities.

Fourth, the time limit on the duration of FOSHU approvals, which was four years, was eliminated. Now there is no expiration date on FOSHU approvals.

It is unclear whether those amendments,(11) which went into effect in the spring of 1998, will increase industry participation in the FOSHU approval system. It is clear, however, that taken as a whole, the amendments weaken the criteria for FOSHU approvals by reducing the quantity and quality of scientific evidence that companies must provide the MHW.

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Copyright 1998 by the Center for Science in the Public Interest. References available by request.