2 dead and 106 hospitalized! Kobayashi Pharmaceutical’s monascus health care products have been upgraded and recalled in China. What is the impact？

Kobayashi Pharmaceutical, once "snapped up" by consumers in China, was caught in a storm of illness and death caused by health care products.

On the evening of March 27th, Kobayashi Pharmaceutical (China) Co., Ltd. issued a statement to assist Kobayashi Pharmaceutical Co., Ltd. to recall the products related to the use of red bream raw materials independently, saying that according to the announcement of Kobayashi Pharmaceutical Co., Ltd., this independent recall involved three products, none of which were listed and sold in Chinese mainland market. Some consumers in China have purchased related products through overseas cross-border platforms, overseas physical stores or other channels, and our company will actively provide assistance in product recycling.

"For products purchased from cross-border official channels, assist Kobayashi Pharmaceutical Co., Ltd. to recycle through UNQ Japan Co., Ltd.. For other consumers, it is recommended to contact the original purchase channel to return the goods. If we encounter problems and difficulties in this process, our company will actively assist and properly solve related matters from the perspective of facilitating consumers. " The statement said that the company had notified the relevant cross-border platforms on March 22, 2024, requesting them to take off the relevant products urgently, and informed all consumers to stop eating immediately as soon as possible. We will continue to inform you many times through Want Want, SMS and other channels to ensure that the information can reach every consumer. For other known platforms with related products for sale, we are contacting the platforms one by one to request that the related products be immediately removed from the shelves and that the platforms inform all consumers to stop eating immediately as soon as possible.

According to CCTV news, NHK reported that the Japanese Ministry of Health, Labor and Welfare announced the second death case after ingesting health products containing red koji from Kobayashi Pharmaceutical Company on March 26th, and the number of people admitted to hospital has increased to 106.

According to Japanese media reports on March 27th, local time, the Osaka city government of Japan ordered Kobayashi Pharmaceutical Company to recall three kinds of products, such as "red yeast cholesterol granules", because the above products received a large number of reports of health damage and death, and the Ministry of Health, Labor and Welfare thought that "it was suspected to contain harmful substances". The monascus involved was produced by Kobayashi Pharmaceutical Osaka Factory, and the company said that it may be different from the expected ingredients from mold that caused the problem.

Prior to this, on March 24th, Kobayashi Pharmaceutical China issued a recall notice to consumers of China e-commerce platform, saying that some affected products were sold to Chinese mainland through cross-border channels, and consumers could return them and get a refund. At that time, in the notice, only one item involved in the product was mentioned.

On March 27th, the reporter contacted the customer service center of Kobayashi Pharmaceutical in China as a consumer. The customer service staff said that only one product in China was added with monascus ingredients, and other products were not. Regarding the safety of health care products containing monascus ingredients, the customer service staff said: "The reply given by our agency is that we have not confirmed whether it is directly related to kidney disease at present." If consumers are worried about health risks, it is recommended to have a kidney examination on blood, and the inspection fee will be reimbursed by the company.

If there is something wrong with the kidney, can it be judged that it is related to the product? The above-mentioned customer service staff said that it depends on the doctor’s judgment. "There must be a problem if it has not been confirmed yet, so the company can’t give a reply for the time being saying that there must be a problem, or there must be no problem."

It is worth noting that there are also domestic health care products companies and pharmaceutical companies that own products containing "red yeast".

On March 27th, Luye Pharmaceutical (2186.HK) told The Paper that the raw material of the red yeast used in Xuezhikang Capsule is a special red yeast produced by Peking University Weixin Biotechnology Co., Ltd., which has independent intellectual property rights and has nothing to do with the raw materials used by Kobayashi Pharmaceutical.

Kobayashi Pharmaceutical was asked to recall three products in Japan. What is "red koji"?

The pathogenic and fatal storm of health care products containing monascus ingredients has been fermented for many days.

On March 22, Kobayashi Pharmaceutical announced that some consumers have recently developed kidney diseases after using the health products containing monascus ingredients produced by the company. Subsequently, Japanese food and alcohol manufacturers also announced the recycling of products related to red koji produced by Kobayashi Pharmaceutical.

On March 25th, Kobayashi Pharmaceutical Co., Ltd. of Japan announced that 33 people had developed kidney diseases and other abnormal health conditions after taking the health products containing monascus, and 26 of them had been hospitalized.

On March 26th, Kobayashi Pharmaceutical Company of Japan announced that a person who might continue to take health products containing monascus for about 3 years died of kidney disease in February. Taking this product is suspected to have a causal relationship with death. An investigation has been launched and people are urged not to use the product for the time being. Also on March 26th, the Japanese Ministry of Health, Labor and Welfare held a three-hour hearing on Kobayashi Pharmaceutical Co., Ltd. on the issue that the raw materials of red yeast rice may cause damage to consumers’ health.

Japanese regulatory authorities have taken measures against Kobayashi Pharmaceutical related products. According to CCTV news, citing Japan’s current affairs news agency, Japan’s Ministry of Health, Labor and Welfare has informed relevant departments in Osaka City where Kobayashi Pharmaceutical Company is headquartered to take measures such as discarding the company’s related products based on the Food Sanitation Law.

According to Japanese media reports on March 27th, local time, the Osaka municipal government of Japan ordered Kobayashi Pharmaceutical to recall three products, including "red yeast cholesterol granules". In addition, Kobayashi Pharmaceuticals of Japan has withdrawn eight kinds of monascus health products from the Japanese Consumer Hall as functional label foods for the record, including three recalled products.

According to Japanese media reports, Kobayashi Pharmaceutical also announced that "Monascus" raw materials are also supplied to 52 companies including beverage and food manufacturers. Among the "red koji" raw materials produced, 20% are used for their own products, and 80% are sold to other enterprises. According to Japanese media reports, Kobayashi Pharmaceutical has supplied raw materials of monascus to other manufacturers through trading companies since 2016, and has been used in Japanese wine and snacks. The suppliers also include enterprises in Taiwan, China.

According to CCTV news, as of the evening of 26th local time, 30 companies, including Kobayashi Pharmaceutical Company, have announced that they have independently recycled the products of Kobayashi Pharmaceutical Company’s monascus raw materials. Some consumers said that this raw material was also used in many foods, even in miso sauce. According to Japanese media reports, relevant Japanese departments will conduct emergency inspections on the safety of more than 6,000 functional foods on the market.

What is the monascus ingredient in the above health care products that may harm health?

According to an article published on February 29th, 2024 by WeChat WeChat official account "Guangdong Traditional Chinese Medicine" sponsored by Guangdong Provincial Bureau of Traditional Chinese Medicine, the traditional Chinese medicine monascus is a kind of rice koji fermented by monascus, which can be used as medicine and food. It was called Danqu in ancient times, originated in China, and has been used for more than two thousand years, and has been popularized among the people as early as the Han Dynasty. Monascus, as a microbial fermented product, can not only be used as a natural non-toxic food pigment, but also be used for antibacterial and antiseptic of meat, fish, beans and other foods. Monascus is also rich in wine fragrance, which is a good raw material for brewing vinegar.

As for the medicinal value of monascus, the above article mentioned that in the late 1970s, Japanese scientists discovered and isolated a chemical component named K(Monacolin K from monascus fermentation broth, and found that it could significantly inhibit cholesterol synthesis in the body. Monascus contains not only monacolin compounds, but also ergosterol, bioflavonoids, saponins, dietary fiber, aminoglycans and other rich physiologically active substances, which have a wide range of pharmacological effects such as lowering blood fat, lowering blood sugar, lowering blood pressure, inhibiting bacteria, resisting tumors and enhancing immunity. Flavonoids, a natural antioxidant in monascus, can protect the liver.

It should be noted that Kobayashi Pharmaceutical once said that after analyzing the components of monascus health products, it was found that some monascus raw materials may contain unknown components beyond the company’s grasp. According to this statement, it is not the monascus itself that causes patients to be admitted to hospital or die, but other unknown ingredients in the raw materials of monascus. Luye Pharmaceutical also mentioned in its response that ordinary monascus is a traditional fermented product, and the differences in strain quality, production technology and quality control management lead to different product quality and safety results.

Gu Zhongyi, director of Beijing Dietitians Association and master of public health in Tsinghua University, said that there is an active ingredient lovastatin in monascus, which can reduce the level of cholesterol in blood, but the specific dosage and effect need to be said separately. Controversially, there will be a secondary metabolite citrinin in the late fermentation of monascus, which has kidney and liver toxicity. Therefore, China has specific requirements for monascus-related products.

Gu Zhongyi stressed that if you buy health food to reduce blood fat, consult a professional or do enough homework according to your own needs, you’d better consult your doctor Yamatonokusushi first. Be sure to read the label information on the product package carefully, especially if it is not clearly marked in Chinese, be sure to consult it before eating. After using any new health food, it is best to record your feelings and symptoms, and stop consulting a doctor immediately if you feel unwell.

Kobayashi Pharmaceutical China recalled a health product containing monascus, and the company said that it could reimburse the inspection fee.

Are health products that may cause kidney disease and even death sold in China?

On March 24th, Kobayashi Pharmaceutical China issued the Notice on Stopping the Use of Red Stork Cholesterol Granules and Self-recall, saying that the company had received some reports that red Stork Cholesterol Granules, a health food manufactured and sold in Japan, might cause kidney diseases after eating it. In view of this situation, we analyzed the composition of this product and its raw materials (manufactured by Zishe), and found that some raw materials may contain unexpected ingredients. Some of the affected products are sold to Chinese mainland through cross-border channels.

Product source mentioned in Kobayashi Pharmaceutical’s China recall notice: Kobayashi Pharmaceutical China official WeChat official account.

"If you have eaten the above products and feel unwell, please consult the customer service center. At the same time, if you hold this product, please contact the customer service center, and we will explain the return and refund methods to you. " China, Kobayashi Pharmaceutical, said that if you have red herring cholesterol granules (60 capsules, barcode 4987072059708), please stop eating.

The above recall notice is for consumers of Tmall Kobayashi’s overseas flagship store, Pinduoduo’s official overseas flagship store and Kobayashi’s overseas direct sales store in JD.COM. On March 27th, a reporter from The Paper searched on the e-commerce platform. Only Tmall could find "Kobayashi’s overseas flagship store", and no health products related to monascus were on sale. However, "Pinduoduo’s official overseas flagship store" and "Kobayashi’s overseas JD.COM direct store" could not be found in Pinduoduo and JD.COM.

China of Kobayashi Pharmaceutical said, "We recognize that this is a serious problem and will continue to investigate.". However, the specific properties of this component and its correlation with kidney diseases have not yet been determined. For the purpose of protecting consumers’ health, we decided to recall the related products of red carp raw materials independently.

On March 27th, the reporter contacted the customer service center of Kobayashi Pharmaceutical in China as a consumer. The customer service staff first asked whether the user had drowsiness, turbid urine and difficulty in urination after purchasing and using this drug. After receiving the reply of "not at present", the customer service staff stressed that "the reply given by our agency is that we have not confirmed whether it is directly related to kidney disease at present". If the consumer is worried about health risks, it is suggested to have a kidney examination on blood, and the company will be responsible for reimbursement of the examination fees.

If there is a kidney problem, can it be judged that the kidney problem is related to the product? The above-mentioned customer service staff said that it depends on the doctor’s judgment. "There must be a problem if it has not been confirmed yet, so the company can’t give a reply for the time being saying that there must be a problem, or there must be no problem."

Kobayashi pharmaceutical products have been "snapped up" by consumers in China.

Kobayashi Pharmaceutical was established in Japan in 1998. Although the company name contains the word "pharmaceutical", it is not a pharmaceutical enterprise in the usual sense. According to official data, Kobayashi Pharmaceutical provides a variety of products in the fields of pharmaceuticals, fragrances, health care products and daily necessities.

Around 2015, Kobayashi’s products in Japan became the target of Japanese tourists’ "buying" in Japan, and the post "You must buy 12 kinds of magic drugs when you go to China" circulated on social networking sites included many products owned by Kobayashi. According to The Paper’s previous report, Kobayashi Pharmaceutical gave people the impression that it was developing the daily necessities production of unique commodities in a Niche Market. Kobayashi Pharmaceutical was rated as an "inbound consumer brand" by the Japanese capital market, and the company’s share price also rose. In 2015, the annual growth rate of Kobayashi Pharmaceutical’s share price reached 40%.

Japanese media reported that the recalled red carp cholesterol granules are said to have the effect of reducing harmful cholesterol values, with annual sales of 600 million yen. The recalled products have been sold in pharmacies in Japan since 2021, with a cumulative sales volume of nearly 1.1 million copies.

Under the influence of the recent turmoil, Kobayashi Pharmaceutical’s share price plummeted, closing down 16.51% on 25th, slightly rising on 26th and closing down 3.83% on 27th.

Part of the products sold by Kobayashi Pharmaceutical in China Source: official website screenshot

In China, Kobayashi’s activities can also be traced back to 1998: Kobayashi Pharmaceutical Co., Ltd., Shanghai Friendship Group and Benfeng Development Co., Ltd. of Hong Kong Special Administrative Region established Shanghai Kobayashi in Minhang, Shanghai. Official website data show that in 1999, the company began to produce and sell domestic colloidal aromatic products. In 2002, Kobayashi Pharmaceutical Co., Ltd. of Japan acquired the shares of Shanghai Friendship Group and Benfeng Development Co., Ltd. of Hong Kong Special Administrative Region, established a wholly-owned company, and changed its name to "Shanghai Kobayashi Daily Chemical Co., Ltd.". In 2023, Kobayashi Pharmaceutical China absorbed and merged with Shanghai Kobayashi Daily Chemical.

According to Tianyancha App, Kobayashi Pharmaceutical Co., Ltd. has invested in three companies in Chinese mainland, including Kobayashi Pharmaceutical (China) Co., Ltd., Hefei Kobayashi Pharmaceutical Co., Ltd. and Shanghai Kobayashi Pharmaceutical Trading Co., Ltd., among which the first two companies are still in existence. Kobayashi Pharmaceutical (China) Co., Ltd. invested in Hefei Kobayashi Commodity Co., Ltd. and Jiangsu Kobayashi Pharmaceutical Co., Ltd., and set up branches in Beijing, Shanghai and Guangzhou.

By category, the products currently sold by Kobayashi Pharmaceutical in China include warm stickers, antipyretic stickers, deodorant, personal care, cleaning products, oral care, disinfectants and so on.

Clarification of domestic drugs and health products: the use of red yeast in products has nothing to do with Kobayashi Pharmaceutical.

It is not a company of Kobayashi Pharmaceutical to use monascus for health care products. The reporter found through wind search that many health care products or pharmaceutical companies such as Tomson Bianjian, Qidi Pharmaceutical, Shouxian Valley and Luye Pharmaceutical have "monascus" related products.

Qidi Pharmaceutical (000590) mentioned in the reply in January 2024 that the registered health food of the company for delaying aging includes red koji soybean isoflavone tablets; At the end of 2023, Shouxiangu (603896) announced that its wholly-owned subsidiary Jinhua Shouxiangu Pharmaceutical Co., Ltd. had completed the registration of domestic health food. Chenguang Bio (300138) mentioned in the semi-annual report of 2023 that the company has the health food registration approval certificate of Caizhiyuan Ginkgo biloba red yeast capsule.

In addition to health care products, there are also pharmaceutical companies involved in monascus-related business. Qianyuan Pharmaceutical has the patent of "a red yeast fermentation device", the application date is April 22, 2022, and the validity period is 10 years.

Xuezhikang of Lvye Pharmaceutical Co., Ltd. is made from red yeast rice and used for the treatment of hyperlipidemia. Regarding the safety of the monascus ingredients in Xuezhikang, Luye Pharmaceutical emphasized that compared with ordinary monascus, Xuezhikang’s raw materials are strictly screened monascus strains, and the production process is strictly controlled. The company conducts regular monitoring according to the requirements of regulatory laws and regulations, and all testing indicators meet the relevant national drug safety management standards, and no unqualified conditions are found. Xuezhikang capsule has been approved for marketing since 1995. A large number of safety research evidences and clinical application data in the past 30 years have fully proved its effectiveness and safety, and the company will continue to carry out safety research, monitoring and analysis of Xuezhikang products. Patients can safely use this product under the guidance of a doctor.