Berman S, Eichelsdoerfer PE, Spicer D, McGann M.
Quality assurance and Lactobacillus-containing dietary
supplements commercially available in Washington State.
Bastyr University, 14500 Juanita Dr NE, Kenmore,
WA 98028-4966. peichelsdoerfer@bastyr.edu
PURPOSE: Probiotics supplements containing live
microorganisms are susceptible to contamination and/or loss of viability
during the manufacturing, shipping, and retail storage processes. This
investigation evaluated commercially available products for viability,
contamination, label accuracy, storage recommendations, and price at
the point of purchase by the consumer.
METHODS: Dietary supplement products containing
Lactobacillus spp. were purchased from retail and professional settings
across Washington State. In addition, a few professional products were
purchased directly from the manufacturers following the purchasing procedures
used by individual health care practitioners in private practice. Following
blinding, products were cultured in duplicate using aseptic technique,
then identified to the genus and species level using polymerase chain
reaction (PCR) technology by an independent laboratory. Pure cultures
of microorganisms known to the investigators were also sent unlabeled
for PCR analysis as laboratory controls. PCR results were then compared
to manufacturer labeling for accuracy.
RESULTS: The final analysis included 94 useable
samples. Of these, 53 (56%) were refrigerated products, and 41 (44%)
stored at room temperature. The laboratory correctly identified all
control cultures. Eighty-three (88%) samples proved viable. For viable
products, culture results matched manufacturer labeling exactly for
seven (8%), while 42 (51%) products contained at least one organism
that matched labeling at both genus and species level. Seventy-three
(88%) products cultured organisms matching labeling at the genus level.
Finally, 67 (71%) of products contained at least one organism not listed
on the label, and eight (10%) cultured more than one potentially pathogenic
organism. The price per minimum daily dose ranged from $0.01 - $3.25.
CONCLUSIONS: Most commercially available
Lactobacillus supplement products available in Washington State
were viable. A large discrepancy existed between labeling and actual
contents as cultured. Refrigerated products were more likely to be viable,
however, no correlation was found between price and quality. The most
commonly identified labeling discrepancy was at the species level rather
than the genus level. Many products contained organisms not listed on
the label; some of these could act as human pathogens, posing risk if
used by susceptible consumers. Quality losses may have occurred at any
of several points between manufacturer and consumer.
Back