sevenmonthtwenty-threeRecently, Kobayashi Pharmaceutical Company in Japan released an investigation report on the deaths of multiple people due to the use of Kobayashi Pharmaceutical's health products. The report found that the management of Kobayashi Pharmaceutical Company failed to take emergency measures as required after discovering safety issues in the company's food production, delayed reporting and concealed information, and bears significant responsibility for the expansion of public health damage. As a result, on the same day, both the president and president of Kobayashi Pharmaceutical Company resigned to take responsibility. bysevenmonthtwenty-oneAccording to a report by Kyodo News, the suspected death toll has reached 101, with over 2000 people seeking medical attention in medical institutions.

This incident was caused bytwo thousand and twenty-fouryearthreemonthtwenty-sixThere are reports thatoneContinuous Consumer NamethreeAfter taking Xiaolin Pharmaceutical's health products containing red yeast extract in the year, he died of kidney disease. Subsequently, multiple cases of physical abnormalities and even hospitalization caused by the use of this health supplement were reported in Japan. After receiving the relevant report, Xiaolin Pharmaceutical Company conducted component analysis on the product and its raw materials, and found that some red yeast raw materials may contain unexpected components. The company subsequently announced a recall of related products and apologized to the affected consumers.the near future,Kobayashi Pharmaceutical Company announced that it will establish a new facility“Compensation corresponding to the headquarters”Specifically addressing health issues caused by health products containing red yeast components. Xiaolin Company will compensate consumers suspected of experiencing symptoms after taking such health products for their medical expenses.

Kobayashi Pharmaceutical Company President Akihiro Kobayashi bows and apologizes at a press conference

According to relevant reports, the health product issues of Xiaolin Pharmaceutical Company are mainly focused on health products containing Monascus components, mainly due to problems in product quality, production management, and regulation.

Substances originating from Penicillium have been detected in the raw materials of Hongqu health products produced by Xiaolin Pharmaceutical“Soft haired penicillin acid”This substance is associated with renal dysfunction, which is one of the health impairments for consumers. In addition, two other unknown compounds were also discovered, which are speculated to be produced by Penicillium mixed in during the cultivation of Monascus. Because Monascus is a product made by breeding Monascus on grains, its fermentation process is complex and difficult to fully control. It is necessary to strictly control the fermentation conditions, otherwise it may introduce other harmful microorganisms or produce harmful by-products.

In production management, as early as 2022elevenIn early October, Kobayashi Pharmaceutical's Osaka factory confirmed the presence of penicillin on the inside of the lid of the red yeast culture tank, but the factory's quality management personnel did not consider it a serious issue, resulting in the continued production and sale of problematic products. According to multiple media reports, Kobayashi Pharmaceutical Company received a report in January this year that health supplements containing red yeast rice ingredients were causing harm to consumers' health. However, it took more than two months to inform the company's external directors and announce the recall decision. Health experts also said that the company still answered questions from doctors about health products after discovering related kidney disease cases“No side effects”. In addition, three years ago, after Xiaolin Pharmaceutical's sales doubled, its red yeast related business has been expanding. However, there is a serious shortage of labor in the production factory, which directly affects the quality control and supervision efforts in the production process.

Kobayashi Pharmaceutical in Japan is involved in the health product Red Yeast Cholesterol Granules

It is worth noting that the regulatory measures for health products in foreign countries, especially in the United States and Japan, are relatively relaxed. Nutritional functional health products only need to be self inspected by the manufacturing enterprises to ensure that the types and contents of the nutritional components they label meet the requirements announced by the Consumer Council before they can be put on the market for sale. Although this regulatory approach has promoted market prosperity and development to a certain extent, it has also brought risks such as difficulty in ensuring product safety, rampant false advertising, and difficulty in regulation.

Coincidentally, in recent years, some "internet famous drugs" in Japan have also experienced frequent failures,two thousand and nineteenyearfourMonth, Canada bans salessixThe eye drops from Japan contain ingredients that are prescription drugs, and self use may cause serious side effects and harm health, according to Health Canada.two thousand and twentyyeartenIn June, the "Children's Cold Syrup" series products, which are widely popular in both domestic and overseas markets in Japan, were urgently recalled on a large scale due to serious oversights caused by incomplete quality inspection processes before leaving the factoryseven hundred and seventy-fiveTen thousand bottles of products; In addition, there are also drugs produced in Japan that are widely popular among purchasing agentsEVEWhite Rabbit Pain Relief Tablets "and Taisho Cold Medicine GoldAGranules, Longjiaosan cough suppressants, etc. have been found to contain special ingredients that have been eliminated in China. These ingredients can have side effects on the human body and pose certain medication risks.

Frequent incidents of this kind not only have a serious impact on the reputation and performance of enterprises themselves, but also raise widespread concerns and doubts about the safety of overseas drugs and health products. Enterprises should strengthen product quality control and management, and regulatory authorities should also increase their supervision of the health product market to ensure the health and safety of consumers.