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Abolish the FOSHU!
Evidence Too Ambiguous to Say "Good for You"

Masanori Suzuki
Professor, Faculty of Sport Sciences Waseda University

I have been voicing my dissenting opinion of abolishing the use of Food for Specified Health Uses (FOSHU)-as well as the system itself-on the grounds that consumers are given no guarantee of the effectiveness of such products. Consumers put their faith in FOSHU products, assuming that they are guaranteed to be "healthy" based on scientific evidence, and that they are approved by the Ministry of Health and Welfare as being effective. But Kao Corp. gave up its FOSHU accreditation after its Econa product, touted as an oil which suppresses body fat gain, was found to contain a large amount of glycidol fatty acid esters, a carcinogen substance.

In fact, we had pointed out that the effectiveness of Econa was dubious (2002). Using rats in their developmental stage to draw comparisons between body fat accumulation and body fat reduction, we found no difference between Econa and vegetable cooking oil. In experiments with test meals cooked by graduate students, consisting of croquettes fried in Econa oil, rice and miso soup, we did not find any of the effects touted in advertisements-such as claims that Econa would burn more fat after meals or that it would not increase neutral fat in the blood as compared with croquettes fried in vegetable cooking oil. The day before we presented the results to the Japan Society for the Study of Obesity (Kyoto, 2002) the principal research investigator of Kao Corp. visited our university and presented his research paper claiming that Econa oil indeed had a low rate of body fat accumulation, but admitting that " effects were not apparent in children or animals in their developmental stage or in adults who were not obese."

I also pointed out the following: that their advertisements were scientifically false and exaggerated, implying that their product was effective for anybody-through their claims that it was "for people who are worried about obesity" or "for the health of your family"-while their data was obtained only from obese subjects; that they must properly inform consumers that they had found dietary effects of Econa only when 8-10 g were taken every day for 12-24 consecutive weeks; that I had personally heard directly from one of the people concerned that they had kept the data from being released outside of the research group and that data was kept as in-house information after it was produced from their company research lab when it did not support product effectiveness; and that they had consulted with universities and other institutions to keep the data from being presented to academic societies or published in papers when the effects that they had claimed were not supported by the results of research activities commissioned to these institutions. If this is true, they are giving consumers only positive information and intentionally suppressing negative information that would be useful for consumers in making purchasing decisions-behavior that verges on criminal activity.

The problem of FOSHU is clearly described in the "Tea Drink That Suppresses the Increase of the Postprandial Glucose Level" paper that we proposed to the Japan Society of Nutrition and Food Science (Nagasaki, 2009). To fight against metabolic syndrome, tea products are available with resistant dextrin or polyphenol added to inhibit digestion and absorption of dextrin and sugar taken as part of the meal, based on the assumption that these additives are effective in suppressing the increase of the postprandial blood glucose level taken as part of the meal for prevention of obesity and diabetes. As far as the scientific evidence of the effects of these tea products, however, the academic paper attached to the application document for FOSHU shows that the evidence was obtained under specific conditions, including the use of rice balls, which easily increase the glucose (blood sugar) level, and plain hot water as the control drink. To compare the postprandial blood glucose level, we experimented with three types of test meals-a pork rice bowl, a salmon lunch, and a hamburger steak lunch-and selected two types of tea, one with added resistant dextrin and another with added polyphenol extracted from guava leaves, using green tea extracted with hot water as the control drink. As a result, the FOSHU tea did not show any effects of suppressing the increase of the postprandial blood glucose level in any of the test meals to a degree that was distinguishable from the control tea. This indicates that the scientific evidence described in the application document for FOSHU does not apply to the diverse conditions of everyday life. After the pork rice bowl was consumed with the FOSHU tea, the postprandial blood glucose level was demonstrably suppressed only when physical exercise was performed using the Brown Rice Dumbbell (300 g) for 15 minutes.

Based on the facts above, potential problems associated with FOSHU are summarized below.

1) Although consumers have purchased the food believing that FOSHU products are scientifically studied and guaranteed to be healthy by the government, it is clear that product effectiveness for every consumer is not in fact guaranteed. We must pay close attention to the public announcement made by the promoters of this system since the beginning, who said that medicine "must be effective" but that FOSHU products "may be effective."

2) Most consumers believe that governmental institutions are involved to ensure effectiveness and safety before the accreditation of FOSHU is granted. In reality, the verification test of Econa for carcinogen substances was conducted only after it was pointed out by an external body, and the government gives permits or accreditation based only on a review of academic papers.

3) To deliver the desired effects to every consumer, FOSHU products must guarantee effectiveness based on the evidence of life science drawn from the diverse conditions of consumers (gender, age, dietary habit, physical activity, life style, health status, etc.).

4) It is practically impossible to meet the conditions described in (2) above-as it would require vast amounts of testing and development funds-and as a result, the FOSHU program cannot credibly issue permits for marketing labels on which the effects are printed, and the program should therefore be abolished.

Transferred from the Ministry of Health, Labour and Welfare, the FOSHU is now handled by the Consumer Affairs Agency which is charged with protecting consumer interests and preventing damage to consumers. We expect that the Agency will certainly not continue using the system without radical reforms, which should include the option of abolishing the FOSHU system which has made a mockery of consumers. Meanwhile, consumers should be careful not to be deceived by the term "scientific" and should improve their capability of making purchasing decisions in terms of food. At the same time, it is essential for us to recognize four fundamental conditions for fitness: orderly life activities, maintaining an 80%-full stomach with a well-balanced diet, engaging in reasonable muscle training activities, and maintaining a peaceful mind.

Masashige Suzuki
Professor on the Faculty of Sport Sciences at Waseda University

Biography
Graduated from the Faculty of Agriculture, Tohoku University; completed the doctorate course in Food Chemistry at the Graduate School of Agricultural Science, Tohoku University; earned a Doctor of Agriculture degree.
Served as Assistant Professor of Physical Education, Tsukuba University; Professor of Physical Education, Tsukuba University; Head Professor for the Doctorate Course of the Institute of Health and Sport Sciences, Tsukuba University; Head Professor for the Doctorate Course of Graduate School, Tsukuba University; Professor Emeritus of Tsukuba University; Professor on the Faculty of Sport Sciences, Waseda University.
Currently: Member of the Paper Review Committee of the Japan Health Food & Nutrition Food Association, Member of the Dietary Education Project "Breakfast" Committee of the Ministry of Agriculture, Forestry and Fisheries (Stable Supply of Rice Organization).
Main publications include "Shin Taishibo Daietto (New Body Fat Diet)," Takahashi Shoten, 1992; "Genmai Niginigi Taiso (Brown Rice Dumbbell Exercise)," Japan Broadcast Publishing, 2001; "Jissenteki Supotsu Eiyogaku Kaitei Sinpan (Practical Sport Nutrition Science: New Edition)," Bunkodo, 2006.