Japan's Kobayashi Pharma factory inspected amid supplement health scare

Credit: Reuters

Japan's health ministry and local authorities on Saturday inspected the Osaka factory of Kobayashi Pharmaceutical following reports of deaths and hospitalizations possibly linked to its dietary supplements containing red yeast rice, known as "beni-koji."

The factory in western Japan, which was making the ingredients of the product named Beni-koji Choleste Help, a type of granules advertised with the effect of lowering LDL cholesterol levels, shut down in December.

However, the Ministry of Health, Labour and Welfare and the Osaka city government decided to carry out an on-site inspection in light of the widening health problems regarding the Osaka-based drugmaker's beni-koji products.

Kobayashi Pharmaceutical on Friday announced one additional death suspected to be linked to the consumption of beni-koji supplements, bringing the death toll to five.

While more than 110 people have been hospitalized over health damage and nearly 700 have either seen a doctor due to health issues or wish to do so, the company, during a press conference held in Osaka on Friday, revealed plans to compensate approximately 800 individuals who reported health issues after consuming the product.

An unintended component called "puberulic acid" has been detected in the company's product, according to Japan's health ministry.

The findings, disclosed by the Osaka-based company during an expert panel meeting convened by the health ministry on Thursday, stated that puberulic acid, derived from blue mold, was identified in a batch of the supplements linked to health issues.

The substance is a potent antibacterial and antimalarial agent that can be toxic, but the extent to which its ingestion may pose health risks or cause kidney damage remains unclear, according to the ministry.

The company rolled out Choleste Help in February 2021, selling around 1 million packages by the end of February this year.

Since last week the health scare over Kobayashi Pharmaceutical's beni-koji supplements has been growing after the company announced that 13 people who took the products suffered health damage including kidney disease.

According to local media reports, it took the pharmaceutical over two months to disclose the damage they had been aware of, and the Consumer Affairs Agency announced plans to conduct an emergency inspection of over 6,000 functional foods.

The voluntary recall of products containing Kobayashi Pharmaceutical's beni-koji as a food ingredient has now expanded nationwide, affecting various products including sake, confectionery, bread and miso.

Earlier reports showed that the company had supplied the rice fermented with red yeast to 52 manufacturers.