Concerns over Japanese drugmaker Kobayashi Pharmaceutical’s health supplement containing red fermented rice, called beni kо̄ji, are growing rapidly following the deaths of two people who had taken it, resulting in a government investigation on possible causal links.

It is unclear whether the two fatalities, along with the hospitalization of 106 people who have consumed the supplement, were caused by the ingestion of beni kо̄ji manufactured by the pharmaceutical company.

Kobayashi Pharmaceutical markets the supplement as a means to lower low-density lipoprotein, or so-called bad cholesterol.

On Wednesday, a meeting of officials from relevant ministries was convened to look into the situation based on data provided by the company.

“We want to exert our full efforts to prevent the spread of harm and investigate the causes,” said Hiroko Otsubo, a senior official at the health ministry.

Reports of negative effects are said to have come from consumers who had taken the supplement manufactured after September 2023, said a health ministry official who briefed reporters after the meeting.

The Osaka-based company said that one of the two individuals who died had ordered packages of its supplement called Beni Koji Koresute Herupu, roughly translated as beni kо̄ji cholesterol supplement, on a regular basis from April 2021 to February 2024. The individual died of acute kidney failure last month.

Kobayashi Pharmaceutical has not disclosed further details, such as gender and age, about the first individual.

The company reported the second death on Tuesday after being summoned by the health ministry. According to autopsy results, the individual had experienced kidney damage, the ministry said.

The Consumer Affairs Agency will conduct an emergency review of about 7,000 food products that claim to promote health, such as those that improve bowel movements, to determine whether they have any harmful effects, the state minister in charge, Hanako Jimi, said on Tuesday.

On Friday, Kobayashi Pharmaceutical voluntarily recalled all of its products that contain beni kо̄ji, citing health hazards possibly linked to the ingredient. It warned consumers not to use three of its products that contain beni kо̄ji, namely:

  • Beni Koji Koresute Herupu.
  • Naishi Herupu + Koresuteroru (roughly translated as supplements to help with visceral fat).
  • Natto Kinaze Sarasara-tsubu Gorudo (roughly translated as nattokinase tablets that treat blood clots).

Since then, the company has recalled some 300,000 packs of its products and received about 3,000 inquiries from consumers regarding the safety of its supplements.

A health ministry panel is aiming to gather expert opinions to consider how to handle products from over 170 companies that use beni kо̄ji from Kobayashi Pharmaceutical, for which no health issues have been reported so far.

DHC, a major health food company, on Tuesday announced a voluntary recall of its supplement DHC Noshuku Beni Koji (DHC Concentrated Beni-koji) sold in Taiwan.

The Tokyo-based company has already halted shipments and ceased sales of the product.

This particular product is manufactured in Japan and sold exclusively in Taiwan, and uses beni kо̄ji from Kobayashi Pharmaceutical. While DHC has not found any issues with the product’s quality, it has suspended sales and voluntarily recalled the products to alleviate concerns.

DHC said a supplement with the same name sold in Japan has a different formulation and does not use beni kо̄ji from Kobayashi Pharmaceutical.

Information from Jiji added