In a significant regulatory action, Japanese health officials inspected a second factory of Kobayashi Pharmaceutical Co. in Kinokawa, Wakayama Prefecture, on March 31, 2024, in connection with a health crisis involving dietary supplements. This follows an earlier inspection on March 30 of another factory in Osaka, as concerns grow over supplements linked to at least five fatalities and over 100 hospitalizations.
The supplements in question, notably including Kobayashi Pharmaceutical’s “Benikoji Choleste Help,” which was marketed as a cholesterol-lowering aid, contain “benikoji,” rice fermented with a species of red mold. It has been reported that about a million packages of these supplements were sold in the last three fiscal years, not only domestically but also to international markets. The crisis comes amid reports that emerged in 2023 of health problems associated with benikoji, despite its long history of use in various products.
The Wakayama plant inspection was conducted under the Food Sanitation Act, with 17 officials from central and prefectural governments involved. The investigation centers around the supplements’ potential link to kidney failures and other health issues. NHK public television broadcast images of the officials entering the facility, highlighting the seriousness of the situation.
Kobayashi Pharmaceutical, based in Osaka, has confirmed its full cooperation with the investigation. Yuko Tomiyama, a spokesperson for the company, stressed the firm’s commitment to understanding the root cause of the health issues, which remain largely unclear. Reports suggest that “puberulic acid,” a natural compound derived from blue mold penicillium, found in the products, may be at the center of the crisis.
This health scare prompted the Japanese health ministry to issue warnings about the supplements and ordered a comprehensive review of the health product approval system. Critics have pointed to recent deregulation initiatives aimed at stimulating economic growth by simplifying and expediting the approval process for health products as a potential contributing factor to the crisis. The rare occurrence of deaths from a mass-produced item in Japan, where government oversight over consumer products is notably strict, has sparked a debate over the adequacy of regulatory frameworks.
On March 22, Kobayashi Pharmaceutical initiated a recall of the supplements, two months after receiving official medical reports about the issue. The company’s president, Akihiro Kobayashi, has issued a public apology for the delay in acting upon the reports. As of the latest updates, the health ministry suspects the supplements could be directly responsible for the deaths and illnesses, with a warning that the number of affected individuals could rise.
The case has not only drawn the attention of national health authorities but has also been noted internationally, with reports of acute renal failure in Taiwan related to the consumption of the supplements. This has led to a broader examination of Kobayashi’s products and the regulatory oversight of health supplements in Japan.
This incident has raised important questions about the balance between promoting economic growth through deregulation and ensuring the safety and well-being of consumers. As the investigation continues, the health ministry has pledged to closely scrutinize the approval system for health products, potentially leading to significant regulatory reforms in response to this crisis.