Non-compliant probiotics: South Korean authorities order four products to be removed from shelves
The products are 1) PB5000 Power Gold Plus from US Pharmatech imported by Mirae Bio, 2) Probiotics 10 Billion from Prime Health, and 3) two batches of capsules from Life Bloom and imported by Jinseong Holdings.
Other than Prime Health, which is from Canada, the other two overseas manufacturers are from the US.
In the case of PB5000 Power Gold Plus, the product was found to contain a probiotic CFU count of 2.9bn CFU/500mg, lower than what was labelled at 10bn CFU/500mg.
Probiotics 10 Billion was also found to have the same issue, where the actual CFU count was 130k CFU/500mg, lower than the labelled amount of 10bn CFU/500mg.
On the other hand, the PB10 Gold-500 capsules was found to be unsuitable for disintegration, although it was labelled as suitable for disintegration.
The Ministry of Food and Drug Safety (MFDS) identified the non-compliant products after conducting an inspection on 37 imported probiotic products between February 15 and March 12.
“This inspection order is a measure that assigns responsibility for safety management to the importers due to the repetitive instances [of non-conformity] in the imported probiotic products,” the MFDS said.
These products, which all expire in 2023, would be withdrawn from the market.
The inspection order, officially announced by the MFDS in February, was specifically put in place for imported probiotic products with three or more past records of failing conformity tests.
Examples of non-conformity include discrepancies in the actual probiotic count and the information placed on the product label, the presence of E. coli and water solubility issues.
According to the order, the importers will need to have the products tested at a MFDS designated facility after receiving the inspection order and submit test results to the local FDA.
“In the future, the MFDS will continue to expand the inspection order system in which business operators self-certify product safety, in order to create an environment where high-quality imported food can be supplied,” the ministry said.
Probiotics, together with omega-3 DHA/EPA, and supplements containing garcinia cambogia extract were linked to the highest number of nutraceutical side effects in the country, the MFDS highlighted.
The side effects included diarrhoea, abdominal pain, nausea, and constipation. For importers of overseas made probiotics, it is obligatory for them to report cases of side effects to the authorities.
