Japan Probes Kobayashi Pharma Factory Amid Deadly Supplement Scare

Japan Probes Kobayashi Pharma Factory Amid Deadly Supplement Scare

Japanese health authorities have initiated a thorough investigation into Kobayashi Pharmaceutical’s factory in Wakayama Prefecture following a series of deaths and hospitalizations linked to the company’s red yeast rice supplement, known as “beni-koji.”

On Sunday, officials from the Ministry of Health, Labour and Welfare (MHLW) and the Wakayama prefectural government conducted on-site inspections under the Food Sanitation Act. The probe aims to uncover the root cause of the health issues associated with the dietary supplement.

As of Friday, the supplement has been linked to five deaths and over 100 hospitalizations, with nearly 700 others seeking or planning to seek medical advice. The product in question, “Beni-koji Choleste Help”, is marketed as a natural remedy to lower LDL cholesterol levels. It was initially manufactured at Kobayashi Pharmaceutical’s Osaka factory, which ceased operations in December 2022.

After the closure, equipment from the Osaka facility was relocated to the Wakayama factory in Kinokawa City, which continued the production of raw materials for the supplement. Sunday’s inspection marks the second consecutive day of scrutiny by health officials, following a visit to the Osaka factory on Saturday.

An unintended compound called “puberulic acid,” derived from blue mold, has been detected in the supplement. According to both the MHLW and Kobayashi Pharmaceutical, the substance is a potent antibacterial and antimalarial agent that can be toxic. However, the extent of its health risks, particularly concerning kidney damage, remains unclear.

Launched in February 2021, “Beni-koji Choleste Help” saw sales of around one million packages by the end of February this year. The widening health crisis has intensified criticism of Kobayashi Pharmaceutical’s delayed response. The company took approximately two months after receiving initial health damage reports to announce a voluntary recall.

The recall has now expanded nationwide, affecting a range of products containing the company’s beni-koji as a food ingredient, including sake, confectionery, bread, and miso. Reports indicate that Kobayashi Pharmaceutical supplied the fermented red yeast rice to 52 manufacturers.

The unfolding situation has raised significant concerns among consumers and industry stakeholders. Authorities are urging anyone who has consumed the affected products to seek medical advice promptly.

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