Probiotics are among the most widely used specialty supplements in the United States according to a recent consumer survey conducted by the Council for Responsible Nutrition.  A continued increase in probiotic usage is expected as companies develop probiotic strains for uses beyond gut health to include sport nutrition, upper respiratory infections, and sleep.  Like many natural products used in dietary supplements, probiotics are presumed to be safe.  This presumption of safety is not completely unfounded as there is global consumption of common probiotics and a lack of reported serious adverse events.  However, as probiotic manufacturers are increasingly seeking to use new strains, species, or even novel probiotics (human commensals but not currently found in the food supply), justification based on a significant history of use may be challenged.  Furthermore, the availability of safety and efficacy data supporting the widespread use of probiotics has been questioned by some healthcare professionals.  Additional criticisms have been directed towards the dietary supplement industry for circumventing FDA review of new dietary supplement products by utilizing the self-GRAS approach. There are efforts underway by a variety of stakeholders including global pharmacopeia and various probiotic and dietary supplement trade associations to develop best practices guidelines for assessing the quality and safety of probiotics.  This presentation will focus on efforts underway to define safety standards for probiotics and justification for continued self-regulation by industry through a self-GRAS path.