Regulatory oversight and safety of probiotic use

Abstract

Depending on intended use of a probiotic (drug vs. dietary supplement), regulatory requirements differ greatly. For dietary supplements, premarketing demonstration of safety and efficacy and approval by the Food and Drug Administration are not required; only premarket notification is required. Saccharomyces boulardii is a probiotic regulatedas a dietary supplement intended for use by the general healthy population, not as a drug to prevent, treat, or mitigate disease. However, since recent increases in incidence and severity of Clostridium difficile infection, probiotics have been used to treat recurrent and/or refractory disease in hospitalized patients. Saccharomyces fungemia secondary to use of the probiotic has been described for patients whoare critically ill, are receiving nutrition enterally, or have acentral venous catheter. Before use of a probiotic is considered for hospitalized patients, careful assessment of riskversus benefit must be made. To ensure patient safety, probiotics should be properly handled during administration.