Explained: What is Japan's dietary supplement that killed 2, left over 100 hospitalised?

Japan issued a nationwide recall of a dietary supplement which was to lower the levels of cholesterol amid speculations that it could have led to two deaths and around 106 hospitalisations in the country. 

Kobayashi Pharmaceutical, which has been selling dietary supplements and over-the-counter drugs, recalled the product after concerns were raised. 

The Japanese government has announced plans to carry out urgent inspections on a specific type of food that claims health benefits, holding producers accountable. This category encompasses around 6,000 products, Japan-based media organisation Kyodo reported.

In a statement, the Ministry of Health said, “Numerous health damage reports have been received from individuals who have ingested certain so-called "health foods" containing red yeast rice, and there have been reports of two fatalities. The relationship with health damage has not been clearly established.”

What is the ‘Beni koji’ supplement in question?

The company recalled five products including around 3,00,000 units of ‘beni-koji choleste help’, which was renowned as being helpful in lowering cholesterol. 

These supplements contained an ingredient known as red yeast rice or ‘beni-koji’. It is made by fermenting rice with monascus purpureus, which is a reddish-purple mould and is renowned for lowering bad cholesterol levels. 

Beni-koji is used for several purposes including food colouring and flavouring. Recalling the product, Kobayashi Pharmaceutical extended its bid to also include food items as well as seasonings — like sake, bread, confectionary, and miso — which contain Beni-koji as an ingredient. 

The online selling of the recalled products has been suspended in China and their circulation has been stopped in Taiwan, as per local media reports. 

Beni-koji's fermentation process can produce a toxin called citrinin, which leads to kidney diseases. However, Kobayashi Pharmaceutical has said it did not find any citrinin in the products. 

The company says that it sells the supplements to 50 firms in Japan and two in Taiwan.

The product was introduced in February 2021 and the company has sold about a million packets, BBC reported.

What happened?

As per the Osaka-based company, one person died from kidney disease and had been consuming beni-koji for the past three years. The second death was reported by the Ministry of Health, Labor and Welfare after a hearing with the company, as per Kyodo. 

Kobayashi Pharmaceutical said on Monday 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”.

Top government spokesman Yoshimasa Hayashi, speaking to reporters said, “The total number of suspected deaths [is now] two and 106 cases of potentially linked hospitalisation also came to light.”

The individual, who was reported to have died first due to the consumption of the supplements, is said to have ordered about 35 “choleste help” units between February 2021 and February 2024. Kobayashi Pharmaceutical has said that it was exploring the link between ingestion and the person's death. 

The company said it received an email from the person's family informing them about the death. However, it only came to notice after inquiries from the public began flooding. It also met with the bereaved family members. 

As per Kobayashi Pharmaceutical, a problematic batch of the supplement was produced at an Osaka factory. 

BBC reported that the affected individuals reported symptoms like changes in urine colour, swollen limbs and fatigue.

What has government and company said so far?

In a press release, Kobayashi Pharmaceutical said, “We have conducted a component analysis of red yeast rice choleste help and the red yeast rice raw material (manufactured in-house) used in it. As a result of our investigation, we have discovered that some red yeast rice ingredients may contain ingredients that we had not anticipated.”

Requesting a recall, it said, “As of March 22, 2024, we have not been able to test all products with serial numbers, and as a precautionary measure, we are requesting a recall of all products. We have been diligently conducting analysis, etc., and as of March 24th, we have completed testing of products manufactured at least for the past year, which has led to the following report. However, as we have not identified any unexpected ingredients or determined whether there is a relationship between this product and kidney disease, etc., we do not intend to change our policy to recall all products, regardless of their serial numbers. There is no such thing. The manufacturing number for Red Yeast Choleste Help, which uses red yeast rice raw materials that may contain ingredients not anticipated by our company, is as follows.”

It added, “Our company has always prioritised the health of our customers above all else and we sincerely apologise for this situation.”

Health minister Keizo Takemi has said that the ministry “will cooperate with Osaka city to investigate the cause … and prevent further health-related damage”. 

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