The Health, Labor and Welfare Ministry has identified puberulic acid, produced by blue mold contamination, as the cause of kidney damage in individuals who consumed Kobayashi Pharmaceutical Co.’s red yeast supplements.
Key Findings and Investigation Details
Contamination Source: Blue mold was detected in the materials used for cultivating red yeast, leading to the presence of puberulic acid in the supplements.
Health Impact: A significant number of consumers of the Osaka-based company’s supplements developed kidney disease, with some cases confirmed as Fanconi syndrome, which impairs renal tubules’ function.
Animal Studies: Experiments indicated that puberulic acid caused kidney necrosis and other damage in rats, supporting the hypothesis of its harmful effects on human kidneys.
Factory Inspections: Blue mold was found in the cultivation chambers and tanks at Kobayashi Pharmaceutical’s factories in Osaka and Wakayama prefectures. Further testing confirmed that the collected mold produced puberulic acid.
Ongoing Research and Additional Compounds
Two other unidentified compounds were also found in products manufactured between June and August last year, a period coinciding with numerous health complaints. The ministry suspects these compounds were also generated due to blue mold contamination.
Further Investigation: The health effects of these unknown compounds are currently undetermined. The ministry plans to conduct additional animal experiments and research to ascertain their impact.
Official Statements and Next Steps
A ministry official emphasized that while puberulic acid is strongly suspected as the cause of the health issues, definitive conclusions cannot yet be drawn. The investigation will continue, focusing on confirming the exact role of puberulic acid and assessing the effects of the additional compounds found.
This development highlights the critical need for stringent quality control in supplement manufacturing to prevent contamination and ensure consumer safety.
