Ensuring Probiotic Quality

Can good bugs be bad?

By Lise Alschuler, ND, FABNO

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Probiotics are a very significant category of dietary supplements, and integrative practitioners frequently recommend them. Their popularity has fueled significant growth of this segment of natural products. However, as we all know, growth is not always good. In the case of probiotics, this booming growth has introduced a variety of products into the market that span the quality continuum from excellent to harmful. Probiotics are susceptible to specific quality issues, and it behooves the practitioner to know about them.

A probiotic is a live organism that, when consumed or administered, confers a health benefit to the host. We are each host to trillions of symbiotic bacteria that happily inhabit our digestive tract, our skin, and our genital areas. Unfortunately, through the ravages of civilized life including antibiotics, sterilized foods, stress, and diseases, imbalances and deficiencies of these commensal bacteria are common. This creates a perfect opening for probiotic supplementation.

In the case of probiotics, this booming growth has introduced a variety of products into the market that span the quality continuum from excellent to harmful.

Although probiotics have been available as dietary supplements for more than 30 years and have been present in cultured foods for far longer than that, the growth of the probiotic supplement market has skyrocketed over the past several years. Globally, probiotic products have sold to the tune of $15.9 billion in 2008. Since 2000, more than 500 probiotic products have been introduced.1 This growth in probiotics has caught the attention of regulators. Recently, the Natural Health Products Directorate (NHPD) of Health Canada revised its probiotics monograph originally released in 2009. This monograph is a guide for the industry in preparing product license applications in Canada for new probiotic products. Existing probiotic products already for sale in Canada will be expected to retroactively comply with this updated guidance.

The revisions to the guidance are directly relevant to practitioners. The revised guidance requires the manufacturers to provide the following information:

  • Genus, species, strain, and source

    • Confirmed by both genotypic and phenotypic characterization
    • Demonstration that the product does not include any strain that possesses antibiotic resistance known to be transferrable; if antibiotic resistance is demonstrated, unambiguous proof of the non-transferrable nature of this resistance must be demonstrated
    • Information about the source and history of the microorganism (eg, human culture)
  • Method of manufacture

    • Purity with specific documentation of the fermentation process used, culture mediums, isolation techniques, etc.
    • Final product testing that confirms identity, potency, quantity, and stability
  • Route(s) of administration, dose

    • The viability of the product (measured in colony forming units [CFUs]) throughout the shelf life under recommended storage conditions
    • Uses and indications (with evidence supporting these uses)
  • Cautions, warnings, and contraindications

  • Storage conditions

This list of product specifications is exhaustive, but absolutely on target. In this age of antibiotic resistance, the concern about potential genetic transference of antibiotic resistance from probiotics to pathogenic organisms is of critical importance. It is equally important that proof of identity go beyond genus and species to include strain. This is crucial for clinicians, since discrete clinical benefits have been documented with specific strains. Purity is important in order to avoid the potential of contamination with pathogenic bacteria. As co-travelers with the desired probiotics, pathogenic bacteria in probiotic supplements would, over the course of daily exposure, result in an increased probability of inoculation. Viability is entirely relevant as die-off of bacteria in supplement forms is a very real phenomenon and, when present, results in a sub-potent or ineffectual products.

While probiotics are tremendously beneficial to human (and animal) health, prescribing clinicians must take responsibility for knowing the products they are recommending by all of aspects mentioned above. This will ensure the consistent use of safe and effective probiotics.

About the Author

Lise Alschuler, ND, FABNO, is a professor of clinical medicine at the University of Arizona where she is the associate director of the Fellowship in Integrative Medicine at the Andrew Weil Center for Integrative Medicine. Alschuler obtained her naturopathic medical degree from Bastyr University where she completed her residency in general naturopathic medicine. She received her bachelor of science degree from Brown University. She is board-certified in naturopathic oncology. Alschuler is past-president of the American Association of Naturopathic Physicians and a founding board member, immediate past-president and current board member of the Oncology Association of Naturopathic Physicians. She is coauthor of Definitive Guide to Cancer, now in its 3rd edition, and Definitive Guide to Thriving After Cancer.


1. Probiotic market—advanced technologies and global market (2009–2014). Markets and Markets Web site. http://www.marketsandmarkets.com/Market-Reports/probiotic-market-advanced-technologies-and-global-market-69.html. Published September 2009. Accessed September 23, 2011.
2 Probiotics. Natural Health Products Ingredients Database. Health Canada Web site. http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=probio&lang=eng. Accessed September 23, 2011.