[Kobayashi Pharmaceutical Red Yeast Incident] Administrative Appeal Filed Against Non-Disclosure Decision (Sho-Shoku-Ki No. 187) by the Food Safety Standards Review Division of the Consumer Affairs Agency (5th Appeal)

On June 15, 2026, our company (Kunsei Club Co., Ltd.) filed an administrative appeal seeking the revocation of the administrative document non-disclosure decision (Sho-Shoku-Ki No. 187) issued by the Food Safety Standards Review Division of the Consumer Affairs Agency. This appeal marks the fifth administrative appeal filed by our company concerning a series of similar incidents. This request was made in response to the division's refusal to identify the source documents (Ministry of Health, Labour and Welfare materials) cited as the basis for the terminology and positioning of "puberulic acid" during a prior telephone inquiry, the failure to receive a callback from the 담당자 (person in charge) for four days, and their subsequent statement of "will not respond" when asked "which Ministry of Health, Labour and Welfare document are you referring to?"

Content of Non-Disclosure Decision (Background)

The Food Safety Standards Review Division of the Consumer Affairs Agency issued an administrative document non-disclosure decision (Sho-Shoku-Ki No. 187) on April 20, 2026. As we understand it, the reason for non-disclosure is that the information dissemination regarding "puberulic acid" was based on or quoted from materials submitted and distributed by the Ministry of Health, Labour and Welfare, and that the agency has not created or obtained administrative documents concerning the decision-making process that led to the terminology and positioning of said substance.

Inconsistency with the Ministry of Health, Labour and Welfare's Decision

Meanwhile, the Ministry of Health, Labour and Welfare, in its administrative document non-disclosure decision notice dated April 22, 2026 (Ko-Sei-Ro-Katsu-0422-No. 2), stated that "there is no record of "puberulic acid" being identified and announced as a causative agent in the red yeast-related incident of Reiwa 6 (2024)," and therefore decided that "no administrative documents concerning the decision-making process have been created or obtained, and none are held."

In other words, while the Consumer Affairs Agency claims the information is "based on or quoted from Ministry of Health, Labour and Welfare materials," the Ministry of Health, Labour and Welfare itself denies the existence of such positioning/announcement and related documents, indicating an inconsistency in their explanations.

Content of Telephone Inquiry (No Callback & Refusal to Respond)

Prior to filing the appeal, our company attempted to confirm by phone with the 담당자 (person in charge) of the Food Safety Standards Review Division of the Consumer Affairs Agency which specific "Ministry of Health, Labour and Welfare materials" were cited as the basis for the non-disclosure decision. However, we did not receive a callback from the 담당자 (person in charge) for four days. Ultimately, when asked "which Ministry of Health, Labour and Welfare document are you referring to?" they explicitly stated, "will not respond." We were unable to obtain a specific explanation regarding the nature of the cited source documents.

It should be noted that within the same Consumer Affairs Agency, the Consumer Safety Division (Sho-Anzen-No. 184) orally indicated the relevant Ministry of Health, Labour and Welfare documents in response to a similar inquiry from our company. In principle, it should be sufficient to provide the relevant documents, and we believe the Food Safety Standards Review Division's refusal to identify them lacks reasonable grounds, especially when compared to the Consumer Safety Division's response.

Filing of Administrative Appeal (5th)

In light of this, we submitted an administrative appeal to the Commissioner of the Consumer Affairs Agency seeking the cancellation of the decision. Since the non-disclosure reason, stating it is "based on/quoted from Ministry of Health, Labour and Welfare materials," is maintained without the source documents being identified, we believe the decision lacks the requirements for application under Article 9, Paragraph 2 of the Act on Access to Information Held by Administrative Organs. This case is the fifth in a series of administrative appeals filed by our company.

Our Recognition

We believe that as long as the basic confirmation of identifying the source documents is not provided, there has not been a sufficient explanation for the non-disclosure. Furthermore, regarding the inconsistency between the explanations of the Ministry of Health, Labour and Welfare and the Consumer Affairs Agency, we will continue to confirm the facts and records, and will release additional information as necessary.

[Company Profile]

Company Name: Kunsei Club Co., Ltd.

Representative: Masao Mori, Representative Director

Location: Hayashima-cho, Tsukubo-gun, Okayama Prefecture

Business Activities: Food manufacturing and sales

Red Yeast Related Information: https://kunsei.com/archives/category/benikoji