Considerations for determining safety of probiotics: A USP perspective

Area of Science:

• Microbiology and Food Science
• Toxicology and Regulatory Science

Background:

• Probiotic safety assessments often rely on historical use, but this is challenged by novel strains and species.
• Global harmonization of probiotic safety requirements for food and supplements is lacking.
• The United States Pharmacopeia (USP) is developing best practices for probiotic quality and safety assessment.

Purpose of the Study:

• To provide a summary guide to global regulatory guidelines for probiotic safety.
• To critically evaluate the suitability of traditional animal toxicology studies for assessing probiotic safety.
• To outline essential parameters for a comprehensive probiotic safety assessment.

Main Methods:

• Review of global regulatory guidelines for probiotic safety.
• Critical analysis of traditional animal toxicology study designs (dose levels, duration, species) for probiotic assessment.
• Inclusion of manufacturing practices in safety considerations.

Main Results:

• Existing regulatory guidelines for probiotic safety lack global harmonization.
• Traditional toxicology studies designed for chemicals may not be optimally relevant for probiotics.
• Manufacturing practices significantly impact the final product safety.

Conclusions:

• A comprehensive probiotic safety assessment requires updated methodologies beyond traditional toxicology.
• Harmonized global guidelines are needed to ensure the safety of novel probiotics in food and supplements.
• The USP is actively contributing to the development of best practices for probiotic safety evaluation.