P3-237 Surveillance of Probiotic Ingredients in Dietary Supplements and Microbial Variations between Product Lots

Tuesday, July 28, 2015
Hall B (Oregon Convention Center)
Tammy Barnaba , U.S. Food and Drug Administration , Laurel , MD
Introduction: Millions of people consume dietary supplements with the intent that these products will provide some health benefit.  Dietary supplements manufacturers are responding to the increase in consumer demand by providing competitive, new products.  Consumers rely on the manufacturer to ensure product integrity and safety as indicated on the product label.

Purpose:  The objective of this work was to develop a whole genome sequencing (WGS)-based protocol to identify microbial ingredients in dietary supplements as to verify label content information as well as the identification of any putative pathogen present. This culture-free method allows for a rapid turnaround time and the potential to be a very powerful analytical tool.

Methods:  Seventeen top selling probiotic supplements have been sequenced without any enrichment.  The sequences were analyzed using a unique K-mer analysis to determine the bacterial content within these samples.  The analysis identifies signature 25-mers and calculates the percentage of reads matched to that unique sequence.

Results: Based on this method, we found labeled probiotic ingredients missing from nine of the 17 surveyed supplements while twelve had additional probiotic strains not included on the label.  Lot-to-lot variations were also detected in ten samples.  One product was found to contain a potentially pathogenic strain of Enterococcus.  In addition, there were instances of taxonomic discrepancies between strains of high genotypic similarity within five products.

Significance: Our data suggest that our culture-free, WGS-based identification protocol could enable the FDA to monitor these supplements to ensure accuracy of manufacturer labeling and product safety in an effort to protect the consumer.