Regulatory oversight and safety of probiotic use

Emerg Infect Dis. 2010 Nov;16(11):1661-5. doi: 10.3201/eid1611.100574.


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 regulated as 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 who are critically ill, are receiving nutrition enterally, or have a central venous catheter. Before use of a probiotic is considered for hospitalized patients, careful assessment of risk versus benefit must be made. To ensure patient safety, probiotics should be properly handled during administration.

MeSH terms

  • Contraindications
  • Critical Illness
  • Dietary Supplements
  • Enterocolitis, Pseudomembranous / prevention & control
  • Fungemia / microbiology
  • Humans
  • Legislation, Drug*
  • Probiotics / adverse effects*
  • Probiotics / therapeutic use*
  • Saccharomyces / physiology
  • Secondary Prevention
  • United States
  • United States Food and Drug Administration