Reports of ill health after consumption of Kobayashi Pharmaceutical Co.'s red yeast rice dietary supplements implicated in two deaths largely relate to products made since September last year, the health ministry said Wednesday.
The findings reported to a meeting of related ministries and agencies come amid a widening scandal over the firm's supplements advertised as cholesterol-lowering.
The products have been implicated in two deaths from kidney-related conditions and over 100 hospitalizations, according to the Ministry of Health, Labor and Welfare, which conducted a hearing with the Osaka-based drugmaker.
Over 170 companies sell products that use Kobayashi Pharmaceutical's red yeast rice, the health ministry said at the meeting, which also included the Ministry of Agriculture, Forestry and Fisheries and the Consumer Affairs Agency.
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The scandal emerged Friday when Kobayashi Pharmaceutical announced it had received reports of ill health linked to its products and voluntarily recalled five of them, including about 300,000 packages of its "beni-koji choleste help" supplements.
Since going public over the issue, there have been reports of two deaths and 106 people being hospitalized after consuming the product. The company has received more than 3,600 inquiries.
The health ministry said both deaths appear to have been caused by kidney issues, but it has yet to receive detailed information.
Kobayashi Pharmaceutical has said the problematic batch of beni-koji was manufactured at a factory in Osaka. The health ministry said it suspects a toxic substance is present in the products.
The firm has said while it has been unable to ascertain a specific cause, it may be due to an unintended red yeast rice extract. The Osaka city government has ordered the company to immediately report the state of its efforts to ascertain the cause and its production methods.
Concerns over the safety of the supplements have also triggered an emergency review of the over 6,000 products currently classed as food claiming functional benefits to the body, such as aiding in reducing body fat or improving eye function.
The classification introduced in 2015 allows companies to label their products as such based on scientific evidence submitted to the Consumer Affairs Agency, but they do not undergo government safety or efficacy inspections.
The case involving Kobayashi Pharmaceutical is the first recall following reports of ill health since the system was established, according to the agency.
Kobayashi Pharmaceutical President Akihiro Kobayashi is set to give a press conference in Osaka regarding the scandal on Friday.
Public health concerns over the products have also spread abroad. In Taiwan, over 120 entries of products have been reported to the island's Food and Drug Administration and pulled from shelves as a preventative measure by some 30 companies.
Earlier in the week, the Taiwan agency identified two Taiwanese companies that imported red yeast rice from Kobayashi Pharmaceutical and instructed them to recall their products made with the ingredient.
