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Probiotic Quality Control Challenges


by Steve Myers -

It is probiotics’ time to shine, but the spotlight on the big stage often reveals imperfections—in this case a few quality-control challenges or issues suppliers and manufacturers need tend to in order to capitalize on the newfound popularity.

As a living organism, a probiotic is not effective if it does not remain viable upon reaching the target body site. Unfortunately, this viability is challenged throughout the entire supply-to-shelf chain. Light, heat, oxygen and moisture can all severely dampen the number of beneficial bacteria that survive shipping, processing, manufacturing, storage and final delivery.

A Probiotic Census

A basic approach is to start with way more probiotic bacteria than is ultimately needed, assuming some of these will perish before the product ends up in consumers’ hands. While this seems like a method prone to a large margin of error, there are things a company can do to best determine how many beneficial bacteria will survive. Mike Bush, vice president of development for Ganeden Labs, explained stability testing can help a manufacturer learn and verify viable probiotic quantities over a specified period of time. Bush noted many companies perform these tests under “ideal” conditions, which is fine if they detail these aspects to customers. “The consumer wants to know how much is in the product when they buy and consume it,” he said.

There has been some confusion in the marketplace over the labeling of bacteria quantity, with some manufacturers listing the amount of viable bacteria at time of manufacture, while others list the expected delivered amount. “The viable amount of probiotics should be at the time of expiration,” said Connie Falkenstein, RD, director of marketing and education for UAS Labs, noting colony-forming units per gram (CFU/g) is an industry standard probiotic manufacturers should use.

The use of CFU/g can both differentiate one product from the next and provide consumers with some sort of dosing platform, but it also provides an indication of the quality-control procedures undertaken by the manufacturer. The difference between being able to list an expected quantity of bacteria through a given date and simply labeling the amount of probiotic at time of manufacture is likely to be the amount of testing performed.

Tim Gamble, senior vice president of sales and marketing at Nutraceutix, reported another questionable labeling issue seen in the industry occasionally is the use of soil-based organisms (SBOs) or spore-forming organisms to inflate viable CFU counts. “These organisms are not always considered true probiotics in academia, nor do they possess the wealth of scientific research of traditional, natural probiotics,” he reasoned. “Their spores do not die off as readily on the shelf and are, therefore, used to spike probiotic products, often solely to maintain organism counts when an investment has not been made in utilizing specialized probiotic manufacturing processes or delivery technologies.” He noted products utilizing a blend of natural probiotics and these soil or spore organisms may test as viable, perhaps even meet label claim, but it is the spore-formers that maintain counts while most, if not all, of the natural probiotics informed consumers are seeking, have died off.

Per current federal labeling regulations, whatever is in the product must be represented on the labeling; so the issue here is companies not listing SBOs and spores, yet using them to boost general viable CFU counts in a formula for, say, lactic acid probiotics. This is similar to spiking issues that have surfaced in other parts of the nutraceutical industry, namely herbal products, although the extent to which this is a problem in the probiotics market is not clear.

“Most companies comply with the label requirements,” assured S.K. Dash, Ph.D., founder of UAS Labs, who confirmed labeling requirements have been dictated by FDA, FTC and other agencies.

What is clear is the top-quality companies test their probiotics at many stages, both internally and via independent labs. For instance, blessed with its own microbiology lab, NOW Foods tests incoming probiotic material to verify the supplier’s certificate of analysis (CofA), in addition to testing at each stage of manufacturing to see how many bacteria are lost due to various processing steps. Combined with its own real-time stability testing, NOW Foods learns how much bacteria must be put in the product initially and what will be left over by a specified date. The company also makes use of suppliers’ stability data on specific strains.

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