A COMPARISON OF THE FOOD AND DRUG REGULATIONS THAT PROVIDE THE FRAMEWORK FOR HOW PROBIOTICS ARE REGULATED IN THE UNITED STATES

Abstract

The increase of products marketed in the U.S. as containing probiotics conferring health benefits has prompted much attention by the scientific, medical and regulatory communities in an effort to examine how these products should be defined, used, regulated and labeled appropriately. Currently, no legal definition, standards, or regulations unique to probiotics exist in the U.S.; therefore probiotics are regulated based upon their intended use as a food, dietary supplement or drug. Food and dietary supplements must only be proven safe, but drug licensure also requires proof of effectiveness. No single cohesive document exists that examines the differences between the requirements for a food, dietary supplement or drug containing a probiotic and how to bridge the gap between them. An examination of the relevant U.S. regulations was conducted to clearly outline how to move a probiotic product from being marketed as a food or dietary supplement to drug licensure.