The category “Food with Health Claim” contains “Food with Nutrient Function Claim” and “Food for Specified Health Use (FOSHU)”. The definition of “Food with Nutrient Function Claim” is “food used to supplement nutritional factors such as vitamins and minerals”. Once certain standards have been met, public sale of the item is possible. In concrete terms these requirements specify that the daily intake of the aforementioned nutritional factors must be within a certain range, as well as the display of health claims and warning labels.
At the same time, because FOSHU possess components capable of affecting physiological function, and their application is essentially as specific health foods, each food to be sold as FOSHU requires authorization from the Japanese Ministry of Health. In this article we focus on the various tests required for approval.

Of “foods for specified health use (FOSHU)”, approximately 90 kinds are presently indicated as “appropriate for hypertension”. In this review we describe their safety and effectiveness.

Among “food for specified health use” (FOSHU), approximately 100 are indicated in the treatment of life-style related diseases related to hypercholesterolemia; in the present review we describe the safety and effectiveness of several of these foods.

Among “food for specified health use” (FOSHU) useful in treating life-style related diseases related to arterial sclerosis are those which create a condition in which postprandial serum triglyceride levels fail to rise or are difficult to pass into the body mass. Approximately 70 such FOSHU are recognized as useful in treating hyperlipidemia; in the present review we describe the safety and effectiveness of several of these foods.

Oxidative stress is considered to contribute to degenerative disease. The urinary excretion of the DNA repair product 8-hydroxy-2′-deoxyguanosine (8-OHdG) is proposed as a noninvasive biomarker of current oxidative stress in vivo. We investigated the effect of an antioxidant mixture on urinary 8-OHdG excretions in 12 otherwise healthy smokers. During the intervention period for 2 weeks, subjects consumed four capsules of PICACE^® (Pycnogenol^® 15 mg/capsule, Vitamin E; 56.1 mg/capsule, Squalene; 138.9 mg/capsule) per day. On days 0 (pre-internal use), 3, 7, 14, and 44, morning urine samples were collected. The urinary 8-OHdG was measured using high-performance liquid chromatography (HPLC). The urinary 8-OHdG level on day 3 was significantly reduced compared to day 0. The level of 8-OHdG after a washout period for PICACE^® (days 44) returned to day 0 baseline. These preliminary data suggest that PICACE^® supplements can protect smokers from oxidative stress and possibly reduce disease risk caused by free radicals associated with smoking.

The sleep-inducing effect and safety of an herbal tea containing valerian and lemon balm were subject to a preliminary open pilot study. Subjects were 14 female volunteers (age 35 ± 11, BMI 21 ± 3 kg/m²) who complained of poor sleep. After obtaining informed consent, subjects took daily 2 cups of herbal teas containing valerian and lemon balm for 1 week, followed by a control week, during which they had two cups of hot water. OSA sleep questionnaires and VAS scales were recorded every day. Sleep quality increased at the 2^nd day after starting the tea, and sleep induction and sleep maintenance were improved in particular. Those whose complaints were severe experienced greater relief than those who complaint a little. Some cases reported transient sleepiness and gastrointestinal complaints. However, these symptoms disappeared spontaneously. The safety and effectiveness of this sleep-inducing herbal tea was ascertained.

An exploratory open-label human clinical study was performed in healthy adults with shoulder stiffness to evaluate the efficacy of Astaxanthin by means of measuring blood flow change in the shoulders and subjective questionnaires on physical conditions, including alleviation of stiffness before and after treatment. Two capsules containing 3 mg Astaxanthin each (6 mg in total) were administered once daily (6 mg a day) on days 1 to 28 (4 weeks) to 13 patients (3 men/10 women). All patients were assessed for efficacy and the study demonstrated significant improvements in physical conditions such as shoulder stiffness, physical fatigue, sense of mental irritation, sense of coldness in hands and feet, eye fatigue and eye bleariness. Significant increases of blood flow in shoulders were observed at the end of treatment using laser-doppler graphics. Blood tests conducted to confirm safety before and at the end of treatment showed no clinical differences, and no adverse side effects were reported. In conclusion, Astaxanthin appeared to safely alleviate stiff shoulders and improve other physical conditions during a 4-week open-label study.

Approximately 100 kinds of Foods for Specified Health Use (FOSHU) are used to “control postprandial elevated blood glucose level”. In this review, we describe their safety and effectiveness.

We conducted a preliminary study of the facial skin-improving effects of collagen-containing beverages as evaluated by objective indices. After obtaining written informed consent, 61 healthy females (age: 25–68, 34±8 y.o.) were randomly divided into two groups, receiving beverages containing 5 g (N=30) and 10 g (N=31), respectively, of collagen daily for one month. Facial skin moisture content and lower eyelid wrinkles were assessed before, 1 week and 1 month after consuming the test beverages. Results were analyzed of the 5 g and 10 g groups, as well as responder and non-responder groups. 10 g collagen beverages showed 50% effectiveness, and were more effective than the 5 g beverage; the effect was observable within 1 week. Furthermore, subjects with more wrinkles and drier skin showed greater benefit than those with higher facial skin moisture content and/or fewer wrinkles. It is suggested that a beverage containing 10 g collagen should be used for aged subjects with more wrinkles and/or drier skin for a period of 1–2 months in future randomized placebo-controlled trials of collagen-containing beverages.

Fresh kiwi fruit freeze-dried juice has been traditionally used for constipation of elderly patients. Its effectiveness and safety was studied in 42 elderly patients (age 60–84: median age 67±6) suffering from mild to moderate constipation, taken as a food supplement of 6 capsules/3 times per day for 4 weeks following a one week control period, after receiving written informed consent. Bowel habits and generic quality of life questionnaires were monitored. Bowel habits such as evacuation time and stool quality improved from the 14^th day and continued for 28 days compared to the control period.
Quality of life in terms of external appearance (such as skin and edema), lumbago, and headache improved. In conclusion, freeze-dried fresh kiwi fruit juice had a laxative and QOL-improving effect on the elderly. No apparent adverse effects were observed.