On March 22, Japan's Kobayashi Pharmaceutical announced the recall of three problematic health products containing red yeast rice ingredients, totaling more than 30 million copies. So far, 5 consumers have died, more than 200 people have been hospitalized, and more than 1,200 people have sought medical attention. According to Japan's Kyodo News Agency, the Japanese Society of Nephrology conducted a survey of nearly 100 patient samples, and the society and Japan's Ministry of Health, Labor and Welfare announced the results on April 9. Most of these patients have abnormal tubular function, which excretes substances needed by the body.
Since Kobayashi Pharmaceutical's problematic red yeast rice ingredients are not only used in pharmaceuticals, the problematic red yeast rice ingredients could affect more than 30,000 companies in Japan, including more than 5,500 food and beverage retailers. The impact of the incident was not limited to Japan itself. In 2015, Japan's then-Prime Minister Shinzo Abe relaxed the development and production standards for some functional health foods in order to boost the economy. In recent years, sales of Japanese influencer health products in China have been booming, and Kobayashi Pharmaceutical has also been developing medicines, household products and cosmetics for Chinese tourists since 2016. The fatal turmoil in Japan's health care products has exposed the risks of the two trends to Chinese consumers, who are increasingly seeking shortcuts to health.
Deadly red yeast rice supplements
In August last year, a Japanese woman in her 40s began taking Kobayashi Pharmaceutical's "red yeast (red yeast rice) cholesterol granules." In December, she felt a headache. Another person experienced persistent tiredness after taking the same medication for about 1 month, which recovered after stopping the medication. Japan's Kobayashi Pharmaceutical Co. said it first received a complaint about the health effects of similar red yeast rice products on January 15, and reported to its president, Akihiro Kobayashi, on Feb. 6 that multiple people were suspected of having their health damaged due to health care product problems, according to Japan's Kyodo News Agency.
Kobayashi Pharmaceutical's problematic health care product containing red yeast yeast ingredients (Photo: Visual China)
However, it was not until March 22 that Kobayashi Pharmaceutical announced the safety risks of its products and announced that it would allocate 1.8 billion yen (about 90 million yuan) for the recall of more than 300,000 products. The recalled products include "Red Yeast Rice Alcohol-Lowering Granules", "Visceral Fat Reduction + Cholesterol Lowering Granules", and "Nattokinase Refreshing Granules GOLD", all of which are cholesterol-improving health products.
At a press conference held in Osaka City on the 22nd, Akihiro Kobayashi apologized for the distress caused to the public, saying, "We must admit that there are deficiencies in product design and quality control systems. "Red Koji Cholesterol Granules" has been available in online and offline stores since February 2021. More than 1 million copies have been sold by the end of February this year, while the products sold last summer and autumn are believed to be the main cause of illness.
Subsequently, the fatal case soon appeared in the Japanese public eye. Kyodo News quoted Kobayashi Pharmaceutical as saying that a consumer who regularly ordered "Red Yeast Rice Alcohol-Lowering Granules" 35 times from April 2021 to February 2024 learned of the death through a family email on March 23 and began to investigate the causal relationship between the drug and the death.
So far, 5 consumers have died, more than 200 people have been hospitalized, and more than 1,200 people have sought medical attention. The Japanese Society of Nephrology conducted a survey of 95 of these patients. On April 9, the Japanese Ministry of Health, Labor and Welfare and the Kidney Society released test results showing that among the five deaths associated with red yeast rice health products, 3 had a history of prostate cancer and malignant lymphoma, of which 4 were over 70 years old and 1 was over 90 years old.
The death toll rises to 5, and Akihiro Kobayashi, president of Kobayashi Pharmaceutical, bows and apologizes (Photo: Visual China)
Japan's Ministry of Health, Labor and Welfare said on March 29 that a toxin produced by Penicillium was detected in red yeast rice supplements, called puberuic acid, presumably caused by contamination during the production process. However, the exact circumstances of how the toxin was incorporated into the product and its production line are still under investigation. The relationship between the toxin and the pathogenic and fatal cases that have been identified so far is also unclear.
According to the Yomiuri Shimbun, Kobayashi Pharmaceutical's plant for the production of red yeast rice raw materials, located in Yodogawa Ward, Osaka City, has been in operation since 1940 and has been closed in December 2023 due to old equipment. The plant also produces red yeast rice ingredients for health supplements and food. The factory had several problems in the production process before. At one point, the plant mixed warm water used to heat the tank into the tank. In April 2023, the factory used materials spilled on the floor to produce red yeast rice ingredients for food. On another occasion, the plant staff forgot to close the lid of the machine used to mix the culture material and placed 33 kilograms of material on the floor haphazardly.
Symptoms such as fatigue, loss of appetite, urinary abnormalities, and edema are common among the people involved in the medical treatment, and most of the patients have "Fanconi syndrome", that is, the decline of renal tubular function. The glomerulus in the kidneys are blood filters that selectively filter parts of the blood to form protourine. The fluid filtered by the glomeruli contains substances that are useful to the human body, such as potassium, phosphorus, sodium, calcium, amino acids, glucose, etc., and healthy renal tubules can be said to reabsorb these substances back into the human body. When people with Fanconi syndrome have problems with the renal tubules, these substances are also lost with the urine, causing the body to experience a variety of symptoms. Most of the 95 patients surveyed by the Japanese Society of Nephrology gradually recovered after taking the supplement, and the other quarter were treated with anti-infective and anti-inflammatory steroids. The Japanese Society of Nephrology calls on people to stop taking the health products involved and seek medical attention promptly.
小林制药出事的保健品药片(图|NHK NEWS)
Red yeast rice (short for red yeast rice), a common ingredient in the three products in this turmoil, is a raw material produced by fermentation of steamed rice mixed with red yeast bacteria. Gu Zhongyi is a director of the Beijing Dietitians Association and has been focusing on the health care products and nutrition industry for more than 15 years. He pointed out that in 1979, Japanese researchers isolated and extracted a substance called "Monacolin K" from red yeast rice, which is also the active ingredient in statins that reduce cholesterol produced by the liver and thus blood lipid levels. This extraction technique is now very well established.
Gu Zhongyi mentioned that in China, the general attitude of doctors is that other statins with stronger potency may cause side effects such as soreness, cramps and even muscle damage, while serious red yeast medicine has fewer side effects than statins, so if the blood lipids are not high to a certain extent, red yeast medicine will be prescribed. In addition to being used in medicines and health products, red yeast rice is also a natural food coloring agent, which is widely used in jams, biscuits, bean curd, flavored milk, natto, pickles and other foods.
Coloured spice red yeast rice (Fig. | Visual China)
In recent years, the increasingly meticulous pursuit of health and the relative proximity of culture have made Japanese health supplements popular among some Chinese consumers. "A lot of the ideas and ideas in East Asia are similar, and Japan is a developed country, and it's very keen on nutrition and health supplements," Gu told the magazine. "Supplements and lozenges like curcumin, natto, and barley that everyone likes to consult have a certain foundation in Japanese culture, and they are also relatively popular in Japan. ”
Red yeast rice health products are also in the midst of the Japanese health care product craze in China. Gu Zhongyi said that due to the wide range of uses of red yeast rice, "there are health foods, ordinary foods, and medicines, and it is difficult to carry out a single classification in laws and regulations", and it is not easy to supervise.
The hidden concerns behind Japan's health supplement craze
On March 24, the official WeChat public account of "Kobayashi Pharmaceutical China" issued a notice mentioning that some red yeast rice raw materials may contain "unexpected ingredients", and some affected products are sold to Chinese mainland through cross-border channels. "None of the three products involved are marketed in Chinese mainland," Kobayashi Pharma China wrote, but "some Chinese consumers have purchased the products through overseas cross-border platforms, overseas physical stores or other channels." ”
Daigou is one of the main ways for Japanese health care products to enter the Chinese market. Although Kobayashi Pharmaceutical has had a Tmall store since May 2016, some products have not been introduced through formal channels in China. But Kobayashi Pharmaceutical, which has a good reputation among Chinese consumers, does not seem to shy away from generating revenue from Chinese tourists. Before the outbreak of the new crown epidemic, there was a "Japanese miracle medicine list" on Weibo and WeChat. Among the 12 "must-buy miracle medicines", 5 are produced by Kobayashi Pharmaceutical, including liquid band-aids, cooling gel tablets, and sprays to relieve stiff shoulders.
Stills from "Queen of Tears".
According to Nikkei, Kobayashi Pharmaceutical has been developing and selling products for Chinese tourists to Japan since 2016. At that time, the brand manager told the Japanese economic news reporter, "Chinese tourists do not come to Japan often, and we will launch large packages." For example, on the "miracle list" of drugs to relieve menstrual irregularities, Kobayashi Pharmaceutical launched a large package of 840 capsules.
Kobayashi Pharmaceutical has a long history, having been founded in 1886. Today, the century-old company, headquartered in Osaka and employing more than 3,500 people, manufactures and sells pharmaceuticals and medical devices. The Nihon Keizai Shimbun has reported that their product names are unique, allowing consumers to immediately understand the effect and usage, such as "throat dew", "refreshing chewing gum", etc., and the simple and easy-to-understand packaging design is also widely praised by foreign tourists. In addition, they produce perfumes, deodorants, hygiene products and frozen shoulder ointments for export to the United States and Southeast Asia.
The Nihon Keizai Shimbun also mentioned that Kobayashi Pharmaceutical is good at developing products that solve consumer problems and open up new market segments. In recent years, generative AI has been used in the development of some products, and AI can be used to assist in transactional work such as collecting creative information and creating documents for new product development.
However, Kobayashi's red yeast rice product business is relatively young, and it can be regarded as the company's imported technology in recent years. In 2016, Kobayashi Pharmaceutical acquired the red yeast rice business from Japanese textile company GUNZE Co., Ltd. The red yeast rice business is not the fist product of "Junshi". Its main business, which is well known to the public in Japan and overseas, is underwear, socks and other products. After the acquisition, Kobayashi Pharmaceutical began to supply red yeast rice as an ingredient for coloring and adding flavor, and expanded its own product line. The "Red Yeast Rice Alcohol-Lowering Granules" in this turmoil was launched in 2021.
According to the Asahi Shimbun report, Kobayashi Pharmaceutical's own use of the red yeast rice raw materials involved in this case accounts for 20%, and the vast majority of them are supplied to other companies as raw materials. CCTV News, citing information released by the Imperial Database of Japan on April 2, said that the most problematic red yeast rice raw materials produced by Kobayashi Pharmaceutical Company are likely to affect more than 30,000 companies in Japan, including more than 5,000 food and beverage retailers. In supermarkets, Japanese consumers have begun to carefully check ingredient lists for red yeast rice ingredients, and some food and dessert shops and retail distributors have also been affected, recalling and destroying their products.
Japan's Kobayashi Pharmaceutical announced the recall of related health products containing red yeast rice ingredients (Photo: Visual China)
Kobayashi Pharmaceutical's 2016 start to aggressively develop its red yeast rice business coincided with the Japanese government's "structural reforms" to loosen regulations and ease restrictions on companies. In Japan's health product system, the "red yeast yeast help alcohol granules" involved are "functional labeled foods". According to Japanese media reports, as part of the deregulation of then-Prime Minister Shinzo Abe, the category of "functional labeled food" since April 2015 does not need to pass the review and inspection of government agencies, nor does it need to provide the government with a scientific basis for food.
"All of my colleagues involved in drug development have doubts," a 62-year-old employee who worked in drug development and quality assurance at a major pharmaceutical company for about 20 years told Asahi Shimbu after the lifting of the lockdown. After the "lifting of the ban", the market for "functional labeled food" in Japan exceeded 680 billion yen, about 4.5 billion US dollars and 32.8 billion yuan, more than double that of 2018.
After the current round of Kobayashi Pharmaceutical's turmoil, the Japanese Consumer Agency is forming a team to discuss the "functional labeled food" system. However, at present, there are still more than 6,800 kinds of "functional label foods" sold in Japan, and there is no shortage of possibilities for them to enter the Chinese market through purchasing agents and other means.
Japanese government officials inspect Kobayashi Pharmaceutical's Osaka plant (Photo: Visual China)
Gu Zhongyi, a nutritionist, told this magazine that he himself often buys Kobayashi Pharmaceutical's antipyretic patches, band-aids, and glasses wiping cloths. For him, although these daily chemical products are not the best price-performance, they are at least from a large and common brand. However, he showed more caution about nutritional supplements: "Don't be too superstitious, many times because of language problems, everyone also understands what it is, so they think that big brands are expensive and popular, so they buy them." But in fact, you still have to make judgments based on your own needs. ”
"Now that people are more concerned about their health, I hope there are some more convenient and simple shortcuts to health," Gu said. "But the medicine that should be taken is the medicine, the life that should be changed is the life-changing, and the space left for intermediate health care products is actually relatively small. ”