Kobayashi Pharmaceutical's "Red Yeast Rice Death" incident fermented, and Xuezhikang and Red Caesar clarified

Blue Whale Finance Tu Jun

Kobayashi Pharmaceutical's red yeast rice turmoil continues to ferment. As of March 28, the number of consumers who died after taking the health supplement increased from two to four, and another 106 people were hospitalized.

On March 22, 2024 local time, Japan's Kobayashi Pharmaceutical Company issued a notice on its official website saying that some consumers have recently developed diseases in the kidneys and other parts after using the company's health products containing red yeast rice ingredients, and some patients have been hospitalized, and some even need dialysis.

On the evening of March 27, Kobayashi Pharmaceutical (China) Co., Ltd. issued a statement to assist Kobayashi Pharmaceutical Co., Ltd. in voluntarily recalling products related to the use of red koji raw materials. The three products involved are Red Yeast Cholesterol Granules, Nattokinase Granules, and Cholesterol Lowering Health Support Granules, all of which contain red yeast rice ingredients and can lower cholesterol as their main selling points, and these three products can be purchased at ordinary drugstores in Japan. A number of e-commerce platforms in China also have official Kobayashi Pharmaceutical stores selling their products.

The Blue Whale financial reporter dialed the service hotline of Kobayashi Pharmaceutical (China) Co., Ltd. as a consumer, and the other party said that it was currently able to send back the product for a refund, but there was no compensation policy at present. As for whether these products will cause harm to the human body, the other party said that if you are worried, you can go to the hospital for a blood test on the kidneys, and the cost of the physical examination can be borne by Kobayashi Pharmaceutical.

It said it may contain unknown ingredients beyond the company's control

Kobayashi Pharmaceutical (China) pointed out in the statement that none of the three products involved in this voluntary recall are on the market in Chinese mainland, and some Chinese consumers have purchased related products through overseas cross-border platforms, overseas physical stores or other channels, for which Kobayashi Pharmaceutical will provide assistance in product recall.

As for why the related products cause kidney risks, the above-mentioned personnel said that the relevant reasons are still under investigation.

Kobayashi Pharmaceutical previously said that after analyzing the composition of red yeast rice health products, it was found that some red yeast rice raw materials may contain unknown ingredients beyond the company's grasp. Kobayashi said that it is still inconclusive whether there is a correlation between this unknown ingredient and the disease of consumers.

Kobayashi claims that it is the only company in Japan that produces red yeast rice using a solid-state fermentation method, where rice is steamed and inoculated with monascus and then solidified into tablets. It is important to note that some red yeast rice produces a toxin called "citrin" during fermentation, which animal studies have shown may cause kidney disease. But Kobayashi Pharmaceutical claims that the type of monascus it has chosen does not produce citrin.

The red yeast yeast raw material in question was produced between July and October last year, and citrinin was not detected, but an unknown ingredient. Kobayashi Pharmaceutical's preliminary analysis suggests that the unknown ingredient may be contaminated with foreign substances, such as molds other than Monascus monascus. It is also possible that Monascus itself produces other unexpected substances.

A number of Japanese biological experts have raised the possibility of foreign body contamination, and Shinsuke Fujiwara, a professor of microbial engineering at Kansai University, said to Japanese media that it may be that Monascus itself produces harmful substances. Although Kobayashi Pharmaceutical claims that the raw materials they use do not contain genes related to the production of citrinin, "due to different cultivation conditions, similar genes may have been activated, resulting in substances similar to citrin." ”

Citrinin and other companies have strict standards to ensure safety

It is worth noting that Kobayashi Pharmaceutical has been providing "red yeast rice" as a food ingredient to beverage and food manufacturers since 2016. Since March 24, a number of companies such as Nippon Takazo Brewery Co., Ltd., FamilyMart Convenience Store, and snack company AEON have announced that they will voluntarily recall products that use Kobayashi Pharmaceutical's red yeast rice raw materials.

On March 24, 2024, Nippon Takashi Brewery Co., Ltd. announced that it had decided to self-recall about 96,000 bottles of the product because it used red yeast rice raw materials provided by Kobayashi Pharmaceutical Co., Ltd. for a liquor produced by the company. There are currently no reports of health damage related to this product from Takazo. Wine manufacturers said that the wine was only exported to Singapore and Taiwan, China, and did not enter the Chinese mainland market.

The reporter asked whether Kobayashi Pharmaceutical had provided relevant red yeast rice products or raw materials to the Chinese side, but the staff refused to reply because "it is inconvenient for other companies to answer".

In terms of domestic enterprises, on March 27, Luye Pharmaceutical told the media that it was very concerned about the recent incident about Xiaolin Pharmaceutical's recall of products containing red yeast rice ingredients, and that the red yeast rice raw materials used in Xuezhikang Capsule are special red yeast rice produced by Peking University Weixin Biotechnology Co., Ltd., which has independent intellectual property rights and has no relationship with the raw materials used by Xiaolin Pharmaceutical.

In addition, an Italian fish oil brand, Omegor Golden Caesar Fish Oil, also posted a safety statement on social media. It said that the Golden Caesar brand immediately sent the existing finished products of its product Red Caesar fish oil for inspection on this (red yeast rice) issue, and the batches currently on sale by Red Caesar have been tested by the NEOTRON authority and have not detected citrin.

Some experts point out that red yeast rice is not uncommon, it has a history of thousands of years, and almost everyone is exposed to red yeast rice in their daily lives. There are three main types of applications for red yeast rice. First, fermented red yeast rice can be used as a functional medicine, secondly, it can be used as a coloring for food dyes, and finally, red yeast rice can also be used as a pure food. The red bean curd and red pastries that the public eats daily are colored with red yeast rice.

Prior to the Kobayashi Pharmaceutical-related incident, there had been no reports of safety issues caused by red yeast rice. Although there are no application standards for red yeast rice included in the Chinese Pharmacopoeia Catalogue, there are very strict restrictions on the fermentation of red yeast rice in some places (mainly in Fujian and Hunan, where red yeast rice is highly produced). For example, aflatoxin (carcinogen) is detected in limited quantities during fermentation, with no more than 5 micrograms of aflatoxin per kilogram of red yeast rice, and citrinin is also subject to strict standards of no more than 5 milligrams of citrinin per kilogram of red yeast rice. The above standards are used to ensure the safety of red yeast rice.

Whether the Kobayashi Pharmaceutical incident was caused by excessive related substances produced during the fermentation of red yeast rice or other impurities is subject to the final investigation conclusion of Kobayashi Pharmaceutical.