Kobayashi Pharma Beni-Koji Case: Causative Substance Announced Without Evidence Procedures, Sample Origin Unconfirmed in Official Documents

### Summary In May and September 2024, the Ministry of Health, Labour and Welfare (MHLW) announced that "kidney damage was confirmed in animal experiments" with puberulic acid. However, the prerequisite evidence collection procedures, specimen receipt records, and supporting documents cannot be confirmed. As a result of information disclosure requests to multiple public agencies, it has been confirmed that no documents exist that form the basis for identifying the cause. This is not merely a procedural error; it potentially means that the preconditions for verifying the basis of an administrative judgment are not met.

### The Publication of Facts (Undisputed Premise) On May 28 and September 18, 2024, the MHLW announced that "kidney damage was confirmed in animal experiments" with puberulic acid. This announcement was widely perceived by society as the identification of the causative substance, through ministerial press conferences and media reports. - Press conference by MHLW Minister Takemi - Reports by NHK, Kyodo News, etc. Furthermore, MHLW officials themselves have not denied the "fact of the announcement."

### However, Evidence Procedures Are Non-existent When the administration handles evidence, it typically records who obtained it, when, and from where. Usually, when the administration treats food as evidence, it is common practice to record the origin and management process of the sample through collection under Article 28 of the Food Sanitation Act. However, in this case, that starting information cannot be confirmed. The following facts have been confirmed by official documents:

**Three Confirmed Facts** 1. The Osaka City Public Health Center did not conduct sample collection (Document: Daidai-ho No. 8562). 2. The MHLW has no records of sample receipt or decision documents (Document: MHLW-ken-sei-0805 No. 2). 3. Nevertheless, it was announced as the "causative substance" (September 18 public materials, Minister's press conference).

### Structural Contradiction These facts create a significant contradiction: - No samples were officially collected. - No receipt records exist. - Yet, a causative substance was identified and announced. In other words, the origin of the evidence does not exist in administrative records.

### An Unverifiable Black Box In this state, the following fundamental questions cannot be answered: - When and where were the samples obtained? - Who managed them, and through what process were they analyzed? - How was the independence of third-party verification ensured?

This matter is independent of the scientific debate over whether puberulic acid is toxic. It is an issue of evidence management: "On which sample was the administrative judgment based?" Normally, the traceability of samples is recorded in administrative investigations, but in this case, the origin information cannot be confirmed. This is an issue of evidence management before it is a matter of science.

### "No Documents Exist" Across All Related Agencies Below are the results of information disclosure requests made to relevant agencies regarding the existence of documents supporting the identification of the causative substance. Requests were made to the following five agencies: - Ministry of Health, Labour and Welfare: Response Nos. MHLW-ken-sei-0919 No. 2 (2025.9.19), MHLW-ken-sei-0805 No. 2 (2025.8.5) -> Documents do not exist. - National Institute of Health Sciences: Response Nos. Eiken-hatsu No. 0926001 (2025.9.26), Eiken-hatsu No. 0306002 (2026.3.6) -> Documents do not exist. - Osaka City Public Health Center: Response No. Daidai-ho No. 8033 (2026.4.20) -> Documents do not exist. - Ministry of Agriculture, Forestry and Fisheries: Response No. 8 Shoan No. 236 (2026.4.21) -> Documents do not exist. - Consumer Affairs Agency: Response Nos. Sho-shoku-ki No. 187, Sho-shoku-hyo No. 319, Sho-an-zen No. 184 (2026.4.20-21) -> Documents do not exist.

It was confirmed that core documents related to the identification of the causative substance do not exist at any of the relevant agencies.

### Conclusion No collection, no receipt records, no supporting documents. Yet, a causative substance was identified and announced.

### The Question The following points remain unconfirmed in this case: - Where were the samples obtained from? - Who received them and by what procedure? - What was the basis used for the administrative judgment?

Unless these points are explained, verification of the said judgment is impossible.