"B. subtilis" and substances derived from it has been evaluated by different authoritative bodies for their safe and beneficial use in food. In the United States, an opinion letter issued in the early 1960s by the Food and Drug Administration (FDA) recognized some substances derived from microorganisms as generally recognized as safe (GRAS), including carbohydrase and protease enzymes from "B. subtilis". The opinions were predicated on the use of nonpathogenic and nontoxicogenic strains of the respective organisms and on the use of current good manufacturing practices. The FDA stated the enzymes derived from the "B. subtilis" strain were in common use in food prior to January 1, 1958, and that nontoxigenic and nonpathogenic strains of "B. subtilis" are widely available and have been safely used in a variety of food applications. This includes consumption of Japanese fermented soy bean, in the form of "Natto", which is commonly consumed in Japan, and contains as many as 108 viable cells per gram. The fermented beans are recognized for their contribution to a healthy gut flora and vitamin K2 intake; during this long history of widespread use, "natto" has not been implicated in adverse events potentially attributable to the presence of "B. subtilis". The natto product and the "B. subtilis" natto as its principal component are FOSHU (Foods for Specified Health Use) approved by the Japanese Ministry of Health, Labour, and Welfare as effective for preservation of health.