Test failures: US, German-made synbiotics, lutein recalled after failing South Korea's inspection

By Tingmin Koe

- Last updated on GMT

A woman conducting factory checks. ©Getty Images
A woman conducting factory checks. ©Getty Images

Related tags MFDS Inspection ecommerce

South Korea’s Ministry of Food and Drug Safety (MFDS) reported that synbiotics and lutein products made in the US and Germany have failed capsule disintegration tests in its latest inspection.

The regulator has recalled these products from the shelves.

It conducted an inspection between April 11 and 22 on both local health functional foods manufacturers and imported products, as that is usually the season when Koreans shop for Parents’ Day gifts. Health functional food such as red ginseng, probiotics, and multi-nutrient products are the common gifting options.

A total of 160 products already distributed within the country were inspected.

Of which, three from the US and Germany were found to have failed the inspection – in particular the capsule disintegration test.

The test is important as it assess the time required and the extent to which a capsule can be broken down into smaller particles for absorption into the body.

Of the three products, two were Enteric Synbiotics 100 and Lutein-alpha manufactured by US Pharmatech Inc and imported by Vitamin Bank. The two products expire in December and October next year respectively.

Probiotics manufactured by US Pharmatech were also previously found​ to have failed South Korea’s inspection test.

The third product to have failed the test was Premium Lutein 20mg made by German firm C. Hedenkamp GMBH & Co. KG and imported by Health House. The product expires in December this year.

At the customs, the MFDS also inspected another imported 377 health functional foods that were pending clearance. All the products, including probiotics, multi-nutrient products, confectionery, tea, and honey have passed the clearance.

The regulator added that it would continue to step up its inspection on health functional foods during festive seasons.

“The MFDS will do its best to prevent safety accidents by conducting inspections on health functional foods, which are consumed at a certain time in the future,” ​it said.  

Good manufacturing practices

On the other hand, the MFDS conducted a check on 101 local health functional foods manufacturers on their compliance to the Good Manufacturing Practices (GMP).

These manufacturers were selected based on a history of non-compliance. Of which, the firm FnBio was the only one found to have failed the GMP requirements.

South Korea has made it mandatory for health functional foods manufacturers to follow the GMP standard since December 2020.​ Companies producing foods for children will also need to follow the Hazard Analysis Critical Control Points (HACCP) system. 

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