Probiotics labelling mismatch? South Korean agency critical of CFU ‘under-reporting’
Common problems found included an underreporting of the colony forming units (CFU) of live bacteria and a disproportionately high number of certain bacteria in products, which claim to contain several bacteria strains.
One of such products is CKD’s Probiotic Lactobacillus 19. As its name suggests, it contains 19 different bacteria species and has a total CFU of 100m.
Tests conducted by Korea Consumer Agency found that it contained 106bn CFU, over 1,000 times more than what was stated on the product label.
Analysis also found that its bacteria composition was skewed to a particular strain - Lactococcus lactis, which took up 88% of the entire bacteria composition.
The remaining 18 strains only accounted for 12% of the entire composition.
In the report, the Korea Consumer Agency detailed the test results of 15 bestselling probiotic products in the country.
The products contained an average of 20bn CFU, which meets the required standard of at least 100m CFU.
However, it highlighted that brands would need to improve their product labelling, to ensure that the product contents matched the actual composition. Although there are labelling problems, the products are found to be safe for consumption.
Jarrow Formulas, Cell Biotech, and Korea Eundan Healthcare were the other brands singled out for labelling improvement.
In the case of Jarrow Formulas, the report said its Jarrow-Dophilus EPS did not state any users’ precautions.
As for Cell Biotech’s DUOLAC Family and Korea Eundan Healthcare’s The Power of Lactic Acid Bacteria, they also had the same problem of underreporting the actual CFU of live bacteria.
The agency said CKD and another company, Kwangdong Pharmaceuticals, had replied to their notice and said they would strengthen their product quality management.
Disparity in testing methodologies?
The underreported CFU of live bacteria could be due to the disparity in testing methodologies used, George Paraskevakos, executive director at International Probiotics Association (IPA), said in response to queries from NutraIngredients-Asia.
“There exists whole-genome sequencing (WGS) and alongside plate counting works well for identification and count but it is understood that disparity in testing methods exist.
“IPA has worked with many government agencies globally and have visited the Korean regulators. We are always open to work collaboratively to advance probiotic education and learning,” he said.
The association recommends that manufacturers label the bacteria strains and CFU per strain in descending order in probiotics products.
At present, countries such as Australia, Canada, Italy and Brazil have already made it mandatory for manufacturers to label the CFU of each strain.
Paraskevakos added that the IPA has published probiotic manufacturing and labelling guidelines and was working on a technical and analytics guideline, which he said when put together, would form the quality guidebook for probiotic products.
Another probiotic expert added that it was extremely rare for probiotic manufacturers to include probiotics at levels multiple times greater than what was claimed in the product label due to the cost involved.
Even if it was for the purpose of ‘overage’, there was no need to add humongous number of bacteria in the probiotic, Evan Hayes, MD ANZ at Factors Group Australia, told us.
‘Overage’ means that manufacturers add in live bacteria in excess of the stated label claim so as to ensure that the product remains valid during the shelf-life period.
Giving the example of a probiotic that claims to contain CFU of 100m and has a shelf life of 18 months, Hayes said that manufacturers would only require 200m to 300m CFU to make the product.
The unexpectedly high CFU detected in some products could also be because the product was not stable, such that “even a bit of extra water could cause the probiotic to grow”, he said.
He also noted that consuming probiotics with high amount of CFU would not lead to major problems but might cause short term discomfort due to the laxative effect of a sudden increase in live bacteria in the gut.
“You could take tens of billions of live bacteria CFU. It is a small amount in comparison to the number of live bacteria in a normal gut.
“However, this can in the short term, cause a laxative effect as a large number of live bacteria at a point in time can affect how much water you pull from your food. If you add a lot more, you may get short term diarrhoea. This side effect passes quickly though.”
He added that most regulatory bodies do not have a limit on the CFU of live bacteria permitted in probiotics, as consuming even tens of billions was recognised as safe.
The report found that the prices of the probiotics varied between KRW$ 92,000 (US$76) and KRW$6,500 (US$5) as of February this year.
The most expensive product was Ultra Flora Probiotics by Esther Formula and the cheapest was CKD’s Probiotic Lactobacillus 19.
Probiotics was the second bestselling health foods in South Korea in 2018.
“Recently, the proliferation of new diseases and an ageing population have increased the interest in healthcare, which has significantly pushed up the sales of probiotics,” the report said.