What's the 'beni koji' death scandal in Japan?

Japanese pharmaceutical giant Kobayashi Pharmaceutical is investigating an 76 more deaths potentially linked to its health supplement tablets containing red yeast rice, known as Beni Koji, which is marketed to lower cholesterol.

This investigation comes after the product was pulled off the shelves a few months ago due to numerous reports associating it with kidney problems, which reportedly resulted in five fatalities and around 100 hospitalisations.

The company denies that the hospitalisations or deaths were related to kidney diseases, however, admits that there were a “variety of cases, including cases in which beni koji-related products may have caused harm somehow and had some indirect impact,” a Kobayashi statement read.

So, what exactly is Beni Koji, and how does it impact health? Let’s delve deeper into its effects and the concerns surrounding it.

What is Beni Koji?

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Beni Koji, also known as red yeast rice, is a traditional Japanese ingredient created by fermenting rice with the reddish-purple fungus Monascus purpureus. Consumed for centuries in countries like China, Taiwan, and Japan, it is valued for its health benefits and distinctive red hue, often used to colour and flavour dishes such as tofu and Chinese rice wine.

In the 1970s, researchers identified ‘monacolin K’, a cholesterol-lowering compound, whose properties are similar to statin drugs, within the mould. Additionally, Beni Koji contains antioxidants, amino acids, and beneficial enzymes that contribute to overall health and well-being.

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This discovery, highlighted by Yumiko Yoshizaki, an associate professor at Kagoshima University and an expert on fermented foods, spurred Beni Koji’s popularity in health supplements, as noted in the Japanese newspaper The Mainichi.

Kobayashi Pharmaceutical utilised Beni Koji in its supplement ‘Beni-koji Choleste-Help,’ promoting its ability to reduce bad cholesterol. However, concerns arose from the presence of citrinin, a toxic byproduct of the fermentation process linked to kidney disease, according to NHK Japan news. Despite these concerns, Kobayashi Pharmaceutical asserted that no citrinin had been detected in their products.

The health concern

As per the Osaka-based company, one person died from kidney disease in March and had been consuming beni-koji for the past three years.

The second death was reported by the Ministry of Health, Labour and Welfare after a hearing with the company, as per Kyodo.

After the reported deaths and dozens of hospitalisations, Kobayashi said in a statement that it did not understand the link between health issues and the company’s products. However, it said the supplements contained “ingredients we had not intended to include”.

“The health issues appear to be concentrated among those who ingested the supplements manufactured after September,” said the Japan Times reported adding that the affected customers reported symptoms such as changes in the colour of urine, swelling in their limbs, and fatigue.

Of the five initial deaths under investigation, the company on Friday it now knows one did not consume red yeast rice.

“We have received 1,656 inquiries from individuals who have sought medical attention, and have 76 cases under investigation over (a causal) connection to the deaths,” in addition to the original four, it said.

The giant recall

As concerns over the safety of Beni Koji surged, Kobayashi Pharmaceutical initiated a global recall of its product.
“Please stop taking our products, and please do not use them in the future,” the pharma manufacturer had apologised to the public as it recalled 3,00,000 units of the cholesterol-lowering supplement.

Kobayashi had exported Beni Koji-based supplements to over 50 companies in Japan and two in Taiwan. In response to the health scare, Taiwanese firms preemptively recalled 154 products, including fermented salted squid, senbei rice crackers, and Japanese sake containing the ingredient from the Osaka-based drugmaker. Online sales of the recalled products were also suspended in China, and their distribution was halted in Taiwan, according to local media reports.

The impact of the recall extended to Europe as well. In France, consumers were advised to consult a doctor before consuming Beni Koji products, while in Switzerland, the sale of foods and medicines containing the ingredient has been banned, as reported by The Mainichi.

Subsequent developments underscored the severity of the situation. Days later, Kobayashi disclosed the discovery of a potentially toxic acid produced by the mold at one of its factories. This revelation prompted Japanese health officials to conduct raids on two of the company’s plants under the Food Sanitation Act.

Addressing the government’s response, top spokesman Yoshimasa Hayashi said in a AFP report on Friday that the health ministry had previously ordered the company to file a daily report on its probe, and demanded more details earlier this month after the number of deaths under investigation didn’t change.

“But until today, it had not reported the specific number of cases under investigation, and it is extremely regrettable,” Hayashi told reporters.

With input from agencies