Japan identifies toxic acid in Kobayashi yeast rice ingredients

Japan's Ministry of Health, Labour and Welfare and other authorities have identified puberulic acid, a toxic substance produced by blue mold, as the cause of the health issues linked to the Kobayashi Pharmaceutical company's supplements containing red yeast rice ingredients.

The investigation will now focus on how the mold contamination occurred and the management system's failure to prevent its growth.

According to health damage reports submitted by the company to the ministry, as of Sept 15, 502 people had been hospitalized, and 120 people confirmed to have taken the supplement had died. The full extent of the Osaka-based company's responsibility has yet to be determined.

The Osaka factory which produced the red yeast rice ingredient was shut down in Dec 2023. It was recognized at the production site that there was the potential for blue mold contamination, yet no measures were taken. The ministry suspects that the blue mold was introduced during the cultivation stage of the red yeast rice.

A key issue will be identifying how the blue mold infiltrated the facility. On-site inspections by the ministry and local authorities revealed the presence of blue mold in both the seed culture room and the air conditioning system at the Osaka factory.

Another area of concern is the safety management system at the production site. Even if the mold had entered the factory, thorough sanitization and cleaning could have prevented its growth.

As of Sept 17, more than 800 compensation claims from victims had been submitted. With the toxic substance responsible for the health damage nearly fully identified, the urgency surrounding compensation efforts has grown.

In July, a man in his 40s from Osaka Prefecture filed a lawsuit against Kobayashi Pharmaceutical in the Osaka District Court, seeking around 4.95 million yen ($34,879) in damages after suffering drug-induced acute kidney damage, having consumed the supplement. As the company's liability becomes clearer, more lawsuits from other victims and business partners may follow.

Kobayashi Pharmaceutical recorded a special loss of 7.9 billion yen in the first half of the year, to cover expenses related to the recall of red yeast rice products. It has been reported that the company is expected to face additional financial strain from compensation claims.

On Wednesday, Hideyuki Yokoyama, the mayor of Osaka, where Kobayashi Pharmaceutical is based, called on all businesses to thoroughly implement hygiene management practices.

The pharmaceutical company announced measures on Tuesday aimed at preventing a recurrence of the issue, focusing on safety management and corporate governance.