Investigating the Lack of Documentation on Animal Tests by the Ministry of Health, Labour and Welfare

Introduction
In a significant move towards accountability, the Kunsei Club, a pharmaceutical company based in Okayama, Japan, has formally requested a review of the Ministry of Health, Labour and Welfare's recent decision regarding animal testing records linked to Kobayashi Pharmaceutical's red yeast rice products. This request marks the 19th appeal made by the company and highlights troubling inconsistencies in the ministry’s public record-keeping related to health matters.

Background
On March 10, 2026, Kunsei Club initiated its inquiry into the potential health hazards associated with Kobayashi Pharmaceutical's products, particularly focusing on the compound known as pubelluric acid. Following a series of public information requests to relevant administrative departments, the company discovered serious gaps in documentation which it believes must be addressed to protect consumer health and safety.

In an official document dated April 22, 2026, the health ministry declared that it had no records relating to the decision-making process for identifying pubelluric acid as harmful, declaring the relevant papers “nonexistent.” This assertion raises critical questions about how such conclusions were reached without documented evidence.

Key Issues at Hand
The core of Kunsei Club's appeal revolves around allegations of contradictory statements from the ministry. In a separate disclosure request, it was similarly revealed that the recorded test samples used for examining the effects of pubelluric acid were neither documented nor received formally. Specifically, the ministry indicated that both the “receipt records” and “approval documents” for the animal test samples were nonexistent.

Adding to this confusion, the Osaka City Health Department acknowledged in an official response dated February 18, 2026, that even as late as March 2026, the regulatory criteria concerning the red yeast rice materials were unclear, thus no legal sampling was conducted. This lack of lawful procurement methods and accompanying documentation for the samples raises serious concerns about the reliability and ethics of the testing conducted.

Kunsei Club's communication on May 14, 2026, with the ministry's Food Safety Division, revealed an acknowledgment of the tests' findings regarding kidney damage purportedly caused by pubelluric acid. However, the absence of sound documentation regarding how these samples were acquired raises significant doubts about the integrity of these findings.

Distinction from Previous Appeals
This latest administrative appeal (the 19th) diverges from the previous set of appeals made by the company (16th through 18th), which focused on the absence of decision-making documents and contradictions with disclosures from the Consumer Affairs Agency. This current request emphasizes inconsistencies directly arising from the health ministry's own earlier disclosures concerning the nonexistence of specimen records.

Administrative Review Request Overview

- Date of Submission: June 21, 2026
- Submitted to: Kenichiro Ueno, Minister of Health, Labour and Welfare
- Challenged Decision: The health ministry's April 22 decision regarding the non-disclosure of administrative documents.
- Objective of the Request: To annul the previous decision and seek a revised document disclosure.
- Legal Basis: Under Article 19 of the Administrative Reconsideration Law of 2014.

Conclusion
This appeal is vital in emphasizing transparency within governmental processes, particularly those impacting public health. It raises important questions about how decisions about potentially harmful substances are made and how essential records are maintained for accountability. As Kunsei Club continues to defend consumer safety, it calls for enhanced scrutiny and better documentation practices by government authorities moving forward.

For those interested in this ongoing situation, further updates can be found on Kunsei Club's dedicated press release archive at their website.