Low biotin content of infant formulas made in Japan

Since minor vitamins such as biotin are not yet registered as food additives in Japan, these cannot be used to supplement infant formulas or foods, despite their nutritional value. Therefore, the biotin contents of infant formulas made in Japan were determined and compared with those from the United States (US). The Japanese products were obtained from five companies, while the US products were limited to those from one company. The average content of total biotin in 11 Japanese products for nursing of normal infants (standard formulas) was 1.04 micrograms/100 kcal (0.69 microgram/100 ml), which was significantly lower than that in two US products (2.56 micrograms/100 kcal, 1.71 micrograms/100 ml). The total biotin content in 26 Japanese infant formulas specially prepared for medical treatment and prevention of disease (special formulas) was 0.45 microgram/100 kcal (0.30 microgram/100 ml) on average. This was less than a fifth of the level in the three US products (1.82 micrograms/100 kcal, 1.22 micrograms/100 ml). There was no difference in the proportion of free biotin (the percent of active biotin to total biotin) between the Japanese and US standard formulas (67.7% and 77.2%, respectively). However, in special formulas the mean proportion of the free biotin in the Japanese products (29.4%) was lower than that in the US products (71.2%). The nutrient intake of infants is limited to the maternal milk and/or infant formulas. These findings suggest that Japanese infant formulas should be appropriately improved to maintain growth and good health. Biotin should be registered as a food additive in Japan so that it can be used to fortify infant formulas.