As consumer demand for probiotics increases, more food and beverage manufacturers are looking to add the healthy bacteria to their products.
While the first step to including a probiotic ingredient in your product is obviously a research review confirming its efficacy and safety, one key element is often left out by manufacturers–strain-specific research. Why strain specific you ask? The strain is the key to identifying one probiotic from another.
To clearly illustrate this issue, we must first consider how probiotic organisms are identified. To appropriately describe a probiotic organism, the genus, species and strain all need to be individually identified:
Again, it is important to drive home the point that safety and efficacy reviews must be performed at the strain level and not at the genus and species level. For example, just because Bacillus coagulansGBI30, 6086 is shown to be safe and effective at given levels, does not meant that another strain of Bacillus coagulans share the same level of safety or efficacy for other strains.
Unless there are documented safety and efficacy data at the intended usage levels, that strain should be eliminated from a review process. It’s important to note that with intended usage levels, the strain under review must have usage levels well below the strain’s safety (GRAS) level. For example, if a strain has a safety limit documented in its GRAS Affirmation of 250 million CFU per day but its efficacious levels are one billion CFU per day, the efficacious levels can not be used in a food product without the food being in violation of food regulations. And again, all of this support needs to be focused on the specific strain.
All too often products claiming to contain probiotic ingredients list the genus and species without references to the specific strain being included. Strain designations are occasionally omitted by accident but more often than not, it is due to the inclusion of generic species that have not been characterised or evaluated for safety or efficacy. So as with most things, it’s buyer beware. Be safe rather than sorry and purchase only strains from reputable, science based companies that provide organisms that have been studied for efficacy, reviewed for safety and be certain to ensure that the efficacious level of the given strain is well below the documented safety limits.
Michael Bush is senior vice president business development at Ganeden Biotech. This is a personal blog and the views expressed are his own.
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