Japanese pharmaceutical company Kobayashi Pharmaceutical is under scrutiny after reports from Japan’s health ministry linked 80 deaths to a yeast-containing supplement marketed to reduce cholesterol. This sharp increase in reported fatalities has drawn attention to regulatory oversight of dietary supplements and how companies manage health-related claims independently.
Initially, Kobayashi Pharmaceutical had disclosed five deaths potentially linked to its CholesteHelp rice and red-yeast pills in March. The supplement, touted for its cholesterol-lowering properties, was found to contain puberulic acid, a toxic compound produced by mold.
Health Minister Keizo Takemi expressed disappointment over the company’s delay in updating the ministry on the situation, calling it “extremely regrettable.” Since March, Kobayashi Pharmaceutical reported receiving medical inquiries from 1,656 individuals and hospitalizing 289 others due to health concerns related to CholesteHelp. The supplement has been recalled from markets in Japan and China, where it was exclusively sold.
Acknowledging the seriousness of the situation, Mr. Takemi announced that the government would now take a more proactive role in the investigation, stepping in to supplement Kobayashi Pharmaceutical’s self-reporting efforts.
Founded in 1919 and based in Osaka, Kobayashi Pharmaceutical manufactures a range of health products, including supplements, hand warmers, and air fresheners, some of which are distributed internationally.
In Japan, regulations governing dietary supplements were established in 2015, focusing primarily on self-reported compliance by companies rather than state-mandated screenings akin to those for prescription medications. This regulatory framework has faced criticism for perceived leniency compared to stricter oversight of pharmaceuticals.
In contrast, the United States has seen calls for more stringent regulations governing dietary supplements following incidents linking certain products to adverse health effects, including fatalities associated with supplements marketed for weight loss and muscle building.
During a press conference in March, Kobayashi Pharmaceutical President Akihiro Kobayashi apologized for the delayed disclosure of potentially related deaths, acknowledging the gravity of the situation without offering further details.
As investigations continue, the focus remains on ensuring transparency and accountability in the supplement industry to safeguard consumer health.
