1 File name: Hoffmanntexteditsclean

Abstract: The recent proliferation of probiotics in supermarkets, drugstores and on the Internet requires consideration of their unique properties in establishing an appropriate framework for their regulation. Although a separate regulatory category at the Food and Drug Administration is not justified, certain reforms should be considered to achieve more efficient regulation and greater reliability on probiotic product claims. Main Text: Initial findings of the Human Microbiome Project (HMP), an NIH Common Fund initiative, to characterize the microorganisms that live in and on the human body and analyze their role in health and disease, were published a little over a year ago (1). While the findings raise more questions than they answer about the role and variation of microorganisms within individuals and across populations, they have already begun to promote the development of probiotics, substances containing live microorganisms 2 that have a beneficial effect when taken in sufficient quantities (2) and “designed to intentionally manipulate microbiome and host properties”(3). The findings will als