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Product Review: Probiotic Supplements (Including Lactobacillus acidophilus, Bifidobacterium, and Others) |
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HOW PRODUCTS WERE EVALUATED:
How Products were Selected:
Products were selected to represent those commonly sold and/or available nationally in the U.S. and Canada. ConsumerLab.com purchased products on the open market through retail stores, on-line retailers, catalogues, or multi-level marketing companies. Products were not accepted directly from manufacturers.
Testing Method:
Products were tested for their ability to disintegrate, amount of anaerobic lactic acid fermenting microorganisms and contamination with other microbes. Analysis for the enumeration of L. acidophilus and other freeze-dried lactic acid microorganisms was performed using procedures as outlined in the Standard Methods for the Examination of Dairy Products (16th ed.) using a modified De Man Rogosa and Sharpe agar (MRS) to which L-cysteine HCl was added and another media, a Reinforced Clostridial agar (Oxoid). Products not having passing levels of anaerobic microorganisms were then re-tested in a second independent laboratory using comparable methods.
Analyses for microbial contaminants were made using methods from the FDA's Bacteriological Analytical Manual (BAM) and included testing for Escherichia coli, Salmonella spp. Staphylococcus aureus, Pseudomonas aeruginosa and other enteric bacteria including Klebsiella, Enterobacter, Proteus, Citrobacter, Aerobacter, Providencia, and Serratia. Testing also included analyses for total yeast and mold.
Disintegration of non-chewable and non-capsule formulations was analyzed utilizing USP (United States Pharmacopeia) 2040 recommendations entitled "Disintegration and Dissolution of Nutritional Supplements" and 701 recommendations (enteric coated). Any product that did not pass the disintegration testing was sent to another independent laboratory in which the same test was repeated. The identities of the products were not disclosed to the laboratories performing the testing.
Passing Score: *
To pass testing, a product had to:
- Have a minimum of 100% of its labeled amount of total anaerobic microorganisms or meet 1 billion microorganisms per maximum recommended daily serving, whichever is greater.
- Meet recommended USP parameters for disintegration for enteric-coated tablets and dietary supplements (excluding capsule and chewable products).
- Test negative for Escherichia coli, Salmonella spp., Staphylococcus aureus and Pseudomonas aeruginosa (as required by the FDA). In addition, contain less than 100 CFU per gram for total coliform and total yeast/mold.
A product passed if it passed each criterion in any one of the analyses.
* Passing scores allow for specific margins of technical error associated with each analysis.ConsumerLab.com reserves the right to disqualify a product at any time from passing its testing if it considers such product to present a safety risk or to provide misleading or inaccurate information in its labeling.
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