Regulatory Oversight and Safety of Probiotic Use

Veena Venugopalan, Kimberly A. Shriner, and Annie Wong-Beringer

Abstract:
Depending on intended use of probiotic(drug vs. dietary supplement), regulatory requirements differs 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 dietar 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.
Probiotics are defined by the Food and Agriculture Organization of the World Health Organization as live microorganisms that, when administered in adequate amounts confer a health benefit on the host. The term probiotic can be subcategorized to include probiotic drugs, probiotic foods(e.g. foods, food ingredients and dietary supplements), direct fed microbials (probiotics for animal use) and designer probiotics (genetically modified probiotics). In the US, probiotic products are marketed to a generally healthy population as foods or dietary supplements.
Recent increases in the incidence and severity of Clostridium difficile infection (CDI)have led some clinicians to consider use of probiotics as "drugs", either alone or in combination with traditional antimicrobial agents for the prevention and treatment of CDI. Several recent reviews have summarized results from clinical studies evaluating the efficacy of probiotics in diarrheal illness. The goal is to highlight the current regulatory oversight for probiotics in US, identify potential risk situations associated with their administration and offer suggestions on practical aspects of probiotic administration to ensure patient safety.
Accordingly to the Food and Drug Administration definition, a drug is an article intended for use as a drug, then it must undergo the regulatory process as a drug, which is similar to that of any new therapeutic agent.




http://www.cdc.gov/eid/content/16/11/1661.htm