Japan recalls 'red rice' health products over suspected link to 5 deaths, more than 100 hospitalized

TOKYO -- Japanese authorities have ordered three "red rice" dietary supplements to be pulled from store shelves nationwide as five users died and more than 100 others were hospitalized, sparking a health scare in the country and across the region.

Osaka-based Kobayashi Pharmaceutical, the company behind the products, also recorded some 12,000 cases of users complaining about health problems, it said during a press conference on Friday. The 114 hospitalized are between 40 and 80 years old, it added.

"We will not only investigate the full extent of this problem, but also prevent it from spreading, and provide explanations and compensation to those customers who have been affected," the company's president Akihiro Kobayashi said.

Japan's Ministry of Health on Wednesday told stores to dispose of all stock of Benikoji ColesteHelp, NaishiHelp Plus Cholesterol and Natto-kinase Sarasara Tsubu GOLD as it investigates Kobayashi Pharmaceutical's products.

All three supplements contain "beni koji" - rice fermented with red yeast - an ingredient said to lower cholesterol levels that is traditionally used in food seasoning and preservation, and rice wine production. Scientists say the fermentation process can, however, produce unsafe levels of citrinin - a toxin that causes kidney dysfunction.

In a phone call with CNN on Thursday, a spokesperson for Kobayashi Pharmaceutical said all four deceased users had suffered from kidney conditions after taking Benikoji ColesteHelp. Two of them had been taking the pills since 2021, when the product was launched, and one began the routine early in 2022, the spokesperson said.

The spokesperson said the company voluntarily began recalling the three products last Friday, days before it revealed the suspected link with the deaths - the cause of which remains unclear.

A preliminary investigation by the firm had detected substances it "did not intend for" in some of the materials used in the manufacturing process, the spokesperson said.

On Friday, Kobayashi said it "cannot rule out" the unintended ingredient causing an adverse effect when mixed with other ingredients.

Kobayashi Pharmaceutical's website says its beni koji products use a strain of bacteria in fermentation that does not produce citrinin.

The firm has delegated several universities to conduct independent analyses, the spokesperson said, adding the batch in question may have been manufactured between April and October last year and shipped between April and December.

No toxin was detected during a screening this February, the spokesperson said.

"We deeply apologize for any inconvenience this may cause to our customers and related parties. We consider this matter to be a serious matter and will continue to investigate," the company said in a statement last week.

Japanese Prime Minister Fumio Kishida on Thursday said the government was investigating the deaths and the suspected link to beni koji, adding it was prepared to act.

"If necessary, we must consider all possible measures," he said.

The reports ignited concern in other parts of Asia, where Japanese health supplements are widely popular.

Kobayashi Pharmaceutical posted a warning on Chinese social media platform Weibo that while the three products are not officially available in mainland China, customers may have bought them online or on visits to Japan. It urged Chinese customers to return the products.

In Taiwan, the Food and Drug Administration ordered distributors to suspend the import of more than 150 products containing beni koji, including those made by Kobayashi.

And in Singapore, authorities recalled a sparkling sake, a type of rice wine, by Kyoto-based Takara Shuzo, which uses beni koji in its production.

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