‘Natural cholesterol inhibitor’ removed from shelves in Japan after four deaths

• Anoma van der Veere

  Japan correspondent

Four people have died in Japan after taking cholesterol inhibitors. Kobayashi Pharmaceuticals, the company that produces the supplement, admits that two deaths have been reported. Today, Japanese Prime Minister Kishida confirmed two other deaths in a parliamentary debate.

One of the deceased patients started taking this supplement in 2021 and died suddenly in February this year due to kidney failure. A total of 106 people have been admitted to hospital with similar complaints. The number of victims is expected to rise significantly in the coming days. The Japanese government has announced a large-scale investigation.

The fact that the matter is only now coming to light is worrying for the Japanese. The deceased patients started taking the supplements in 2021 and 2022, but the popular product Benikoji Chole-help was only recently recalled and until recently was still on the shelves of major drugstores and supermarkets.

Benikoji is widely used in Japan, in both supplements and food products. The ingredient consists of a mix of the benikoji bacteria and steamed rice, a process that produces a red-colored fermented ingredient. Consuming this should lower ‘bad cholesterol’ in the blood. It is therefore used in many health products that claim to be ‘natural’. Because it is a supplement, it is available in stores without a prescription.

Despite its free availability, there were signals for years that there were health risks associated with it. According to Japan’s Food Safety Authority, reports of possible health problems resulting from regular use have been made previously.

In 2014, Switzerland banned all benikoji products and the French government warned the public to consult a doctor before taking them. Under current EU measures, many products containing the drug can no longer be sold, but there is no question of a complete ban.

In Japan, the government is now trying to get a grip on the situation. “We will take appropriate measures if necessary,” Prime Minister Kishida said in a parliamentary debate this morning. The government today announced a large-scale investigation into possible abuses at the pharmaceutical company Kobayashi.

The government spokesperson has indicated that all available information will be handed over to the World Health Organization. The Ministry of Health is holding an emergency session with food safety experts today and indicates that it will issue official advice on the use of benikoji based on this. A minister says he is evaluating about 7,000 products that claim to provide special health benefits.

In Osaka, the city where the vast majority of production takes place, the municipality took immediate steps to remove the products from the shelves. Supplements made from fermented red rice are now banned under a stricter hygiene law. The municipality has launched an emergency investigation into 52 local companies that purchased the ingredient from Kobayashi and incorporated it into their own products.

Although the production of benikoji can cause toxins, the company behind the supplements states that it uses a safe strain of bacteria in the production process. The benikoji is made in our own factory and then shipped to third parties who process the original ingredient into a range of supplements.

A total of 170 companies purchase the product from Kobayashi. Representatives say they have not found any unsafe ingredients that could be causing the health problems. Despite this, Kobayashi has voluntarily recalled five products, including 300,000 packages of Benikoji Chole help.