Kobayashi Pharma Beni-Koji Case: Causative Substance Announced Without Evidence Procedures, Sample Origin Unconfirmed in Official Documents
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76/100
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8
AI Summary (NQ-processed)
Kunsei Club Co., Ltd. has raised serious questions about the administrative procedures behind the Ministry of Health, Labour and Welfare's (MHLW) announcements in May and September 2024, which identified "puberulic acid" as the causative substance in the Kobayashi Pharmaceutical beni-koji (red yeast rice) issue. Following freedom of information requests filed by the company to multiple public bodies, it was revealed that no official documents exist, such as "sample collection records" or "receipt records," that could verify the origin of the specimens used for testing. Kunsei Club points out that this lack of a documented evidence trail makes it impossible to verify the conclusion, as the traceability of the evidence forming the basis of the administrative decision cannot be confirmed.