Animal Testing Samples Lack Receipt Records or Approval Documents — Administrative Review Request Filed with Health Minister Over Untraceable Sample Use (19th in Series)

Kunsei Club Co., Ltd. (Hayashima-cho, Okayama Prefecture, Representative Director and Pharmacist: Masaki Mori) has been verifying facts through information disclosure requests to relevant government agencies since March 10, 2026, following health damage incidents linked to red yeast rice products by Kobayashi Pharmaceutical Co., Ltd. This press release reports on the 19th administrative review request filed on June 21, 2026, with the Minister of Health, Labour and Welfare.

The subject of this request is the Ministry of Health, Labour and Welfare's administrative document non-disclosure decision dated April 22, Reiwa 8 (MHLW Health 0422 No. 2). The Ministry declared that documents concerning the decision-making process for identifying "puberulic acid" as the causative substance "do not exist" and therefore were not disclosed.

[Key Issue: Contradiction with MHLW's Own Disclosure Records]

In a separate disclosure request decision (MHLW Health 0422 No. 3), the Ministry stated that it neither created nor acquired, and thus does not possess, the "receipt records" or "approval documents" for the samples used in animal testing of puberulic acid (7-day repeated oral toxicity tests on rats administered BK1, BK2, and PA).

Additionally, the Osaka City Public Health Center Director clearly responded in a letter dated February 18, Reiwa 8 (Osaka-Hoken No. 8562) that, as of the end of March, Reiwa 6, it was not clear whether red yeast rice raw materials fell under Article 6, Paragraph 2 of the Food Sanitation Act, and therefore no statutory sampling ("collection") of "raw red yeast rice" was conducted under Article 28 of the same Act.

Therefore, the samples used in these tests: (1) were not obtained through statutory collection, and (2) lack any receipt records or approval documents, meaning there is no record of when, from whom, or by what method they were acquired.

[Company's Position]

When Kunsei Club inquired by phone to the MHLW's Food Safety and Monitoring Division on May 14, Reiwa 8, the official confirmed that both public announcements made on May 28 and September 18, Reiwa 6, stated that "kidney damage caused by puberulic acid was confirmed in animal testing." The company is now challenging, through this review request, the rationale and document management practices behind conducting tests and publicly announcing results twice using samples whose origin and acquisition method are entirely unrecorded.

[Differences from Previous Requests (16th–18th in Series)]

The 16th to 18th requests, announced on July 5, 2026, questioned the non-existence of decision-making documents and contradictions with documents disclosed by the Consumer Affairs Agency. This 19th request differs in focus, centering on the contradiction between the Ministry's own disclosure statements (that receipt and approval documents do not exist) and the use of such samples in official testing.

[Overview of the Administrative Review Request]

Filing Date: June 21, 2026 (Reiwa 8)

Recipient: Minister of Health, Labour and Welfare, Kenichiro Ueno

Subject Decision: MHLW Health 0422 No. 2 (Notification of Non-Disclosure of Administrative Documents) dated April 22, Reiwa 8

Request: Cancel the decision and issue a new disclosure decision

Legal Basis: Article 19 of the Administrative Review Act (Act No. 68 of 2014)

▼ This press release is the 107th in a series issued since March 10, 2026.

The complete series is available at https://kunsei.com/archives/category/benikoji

[Company Overview]

Company Name: Kunsei Club Co., Ltd.

Representative: Representative Director and Pharmacist, Masaki Mori

Address: 611-1 Maekata, Hayashima-cho, Tsukubo-gun, Okayama 701-0303

Business: Manufacturing and sales of ham and sausages

Contact: [email protected]