2024 Kobayashi Pharmaceutical Red Yeast Rice Incident: Information Disclosure Request to Ministry of Health, Labour and Welfare Reveals 225 Companies Publicly Named, No Official Record of Decision-Making

Press Release

Facts revealed by an information disclosure request to the Ministry of Health, Labour and Welfare

225 companies publicly named, no official record of decision-making

— The department in charge, decision-maker, and date of decision all unknown; revealed by information disclosure request to the Ministry of Health, Labour and Welfare

This case concerns the large-scale public naming of 225 food-related companies, for which the underlying documents for the decision-making process were not confirmed through an information disclosure request. For the public announcement involving 225 companies, it is not possible to confirm "who, when, and on what basis" the decision was made from the records. The fact that administrative records showing the decision-making process were not confirmed, despite the large-scale public naming of 225 companies, raises serious questions regarding the principle of administrative record-keeping and accountability.

Kunsei Club Co., Ltd.

■ Overview of the background

■ Facts revealed

In 2024, the Ministry of Health, Labour and Welfare announced the names of companies using red yeast rice in connection with the Kobayashi Pharmaceutical red yeast rice product issue. The public disclosure covered 52 companies indicated by the MHLW and others, plus 173 additional companies, totaling approximately 225 companies.

In the same year, our company submitted information disclosure requests to both ministries. As a result, the following facts were confirmed by the administration's own response documents:

① There is no official document designating and publicly announcing puberulic acid as the causative substance.

Disclosure Request: March 20, Reiwa 8 (2026) / Administrative Response: April 22, Reiwa 8 (2026) (MHLW Health and Welfare Bureau, Document No. 0422-2)

[Administrative Response] "There is no fact of positioning or publicly announcing puberulic acid as the causative substance, and as such, it is not actually held, therefore, disclosure was denied."

Details: https://kunsei.com/archives/785

② There are no underlying documents created or held for the public naming of 225 companies.

Disclosure Request: May 16, Reiwa 7 (2025) / Administrative Response: June 17, Reiwa 7 (2025) (MHLW Health and Welfare Bureau, Document No. 0617-10)

[Administrative Response] "No facts of creation or acquisition during administrative processing, and as such, it is not actually held, therefore, disclosure was denied."

Details: https://kunsei.com/archives/773

[The biggest point of contention in this case] Since 2024, the administration, expert committees, media reports, and parliamentary deliberations have all practically assumed that "puberulic acid is the causative substance." However, the Ministry of Health, Labour and Welfare explicitly stated in its response to the information disclosure request that "there is no fact of positioning or publicly announcing puberulic acid as the causative substance." This contradiction affects the very foundation of this matter.

[Confirmed facts]

・ Documents regarding the designation/public announcement of puberulic acid as the causative substance: Responded as non-existent.

・ Documents regarding the decision-making for public naming of companies: Responded as non-existent.

[Their meaning]

These results indicate that the records of the decision-making process in this matter were unconfirmed. Normally, when an administrative agency publicly names companies, decision documents, consultation records, and supporting materials are created. In regular administrative procedures, when undertaking serious measures such as public naming of companies, at minimum, ① decision documents, ② consultation records, ③ verification materials for relevant laws and standards, and ④ communication records between responsible departments are created and preserved. To our knowledge, we are not aware of any instances where none of these records were confirmed for a public naming involving 225 companies. As far as our company has confirmed, neither the Food Sanitation Act nor the Consumer Safety Act explicitly authorize the listing and public naming of businesses at a stage where the cause is undetermined.

This means that in this case, public naming of companies may have occurred without underlying documents at an undetermined cause stage.

This case potentially involves serious issues from the perspective of the appropriateness of administrative procedures and accountability. The consistency with the obligation to provide reasons and accountability under the Administrative Procedure Act, and with the principle of administrative record-keeping, are called into question.

Furthermore, regarding damages caused by public naming without underlying documents, there is room for consideration in relation to Article 1 of the National Compensation Act (illegality/negligence in the exercise of public authority). Consistency with the requirement to state reasons under Article 8 of the Administrative Procedure Act is also questioned.

■ What the public naming of companies caused

The public naming, unconfirmed by underlying documents, functioned as a de facto social sanction against the target companies. The publicly named companies suffered significant business disadvantages, which in effect amounted to an administrative disposition. Disadvantages arose at the stage of suspicion, and a situation where subsequent correction is extremely difficult was created under administrative leadership.

・ Products from companies using red yeast rice were simultaneously withdrawn from stores, regardless of their causal relationship with Kobayashi Pharmaceutical.

・ Numerous contracts and orders from business partners were halted.

・ The social image of "red yeast rice = dangerous" has become established and has not yet been dispelled.

Our company (Hayashima-cho, Okayama Prefecture, Representative Director and Pharmacist Masaaki Mori) continues to suffer the following damages:

・ Transaction volume decreased by approximately 50%.

・ Red yeast rice related sales halved (ongoing since 2024).

・ No prospect of recovery is currently in sight.

[Impact on the industry] According to our company's survey, before the red yeast rice incident, there were approximately 300 companies in Japan handling red yeast rice foods, but currently there are fewer than 10.