A total of 212 people in Japan have been hospitalized due to health issues related to the consumption of a dietary supplement containing red yeast rice, also known as beni-koji, according to recent local media reports. The supplement was manufactured by Kobayashi Pharmaceutical. This figure was updated as of Sunday, including those who have been discharged. The Ministry of Health, Labor, and Welfare stated that a total of 1,224 people sought medical attention by Sunday and that approximately 53,000 inquiries were directed towards the company.
The health ministry received a report from Kobayashi Pharmaceutical regarding the beni-koji ingredient, which stated that there was a two-month gap between identifying health problems and publicizing them. This sparked discussions during interviews at Kobayashi Pharmaceutical’s headquarters in Osaka on Saturday. Chief economist Hidetoshi Tashiro of Japan’s Sigma Capital Ltd. stated that the crisis at Kobayashi Pharmaceutical revealed organizational issues within the company. He alleged that, as a typical Japanese family-owned enterprise, the drug maker might prioritize family interests over customer interests in decision-making. Tashiro also stated that the company’s failure to take immediate action or report the health issues to authorities exacerbated the crisis.
The company’s product, a red yeast rice dietary supplement called Beni-koji Choleste Help, has been linked to five deaths from kidney diseases. The product, which was rolled out in February 2021, was advertised as having the effect of lowering LDL cholesterol levels. At the end of February, it had sold around one million packages. The health ministry and the company revealed that an unintended component called puberulic acid, derived from blue mold, was detected in the product manufactured at the Osaka factory of Kobayashi Pharmaceutical. This factory was shut down in December 2023.
According to the health ministry, puberulic acid is a potent antibacterial and antimalarial agent that can be toxic. However, the extent to which its ingestion may pose health risks or cause kidney damage remains unclear. Although the Food Sanitation Act requires businesses to inform local authorities when health issues are identified, it is possible that the company was not aware of the situation.