Kobayashi Pharmaceutical Red Yeast Rice Incident: Consumer Affairs Agency's Consumer Safety Division Confirmed by Phone — Source Cited, but Discrepancy with MHLW Document Remains 'Unknown'

Kobayashi Pharmaceutical Red Yeast Rice Incident: Consumer Affairs Agency's Consumer Safety Division Confirmed by Phone — Source Cited, but Discrepancy with MHLW Document Remains 'Unknown' — Administrative Review Request Filed Against Non-Disclosure Decision —

As of the publication of this release, Kunsei Club has not received a response from the Consumer Affairs Agency regarding an open inquiry letter sent on June 3, 2026, with a response deadline of June 15, 2026.

On June 15, 2026, the company filed three administrative review requests against non-disclosure decisions issued by three divisions within the Consumer Affairs Agency: the Consumer Safety Division, the Food Labeling Division, and the Food Hygiene Standards Review Division. As this case involves multiple divisions, the company will disclose the background in three separate reports. This release covers the Consumer Safety Division portion, including details of a phone inquiry conducted prior to filing the review request.

Non-Disclosure Decision by the Consumer Safety Division

The Consumer Safety Division issued a non-disclosure decision (Shoanzen No. 184) on April 21, 2026. The reason cited was: 'All instances where the term 'puberulic acid' was used in public communications (alerts, Q&As, etc.) were either materials submitted by the Ministry of Health, Labour and Welfare (MHLW) or direct quotations from MHLW-distributed documents. The Agency has neither created nor obtained any administrative documents regarding the decision-making process behind the use of this term, and therefore does not possess such documents.'

Phone Confirmation Prior to Filing the Review Request

Prior to filing the administrative review, the company conducted a phone inquiry with the Consumer Safety Division's document disclosure officer. The officer carefully confirmed that the MHLW materials cited as the source for the term 'puberulic acid' were the red yeast rice-related public alerts and Q&A documents published on the MHLW’s official website.

However, when the company asked: 'The Ministry of Health, Labour and Welfare itself stated in its disclosed document (MHLW Health Bureau Notification No. 0422-2, dated April 22, 2026) that it “has not publicly announced puberulic acid as a causative substance.” Given that the source agency itself denies this, how should the relationship between the two agencies be understood?', the officer responded, 'I don’t know.'

Proceeding to Review Request Despite Unresolved Discrepancy

This phone inquiry confirmed that the Consumer Safety Division used the term 'puberulic acid' based on materials published by the MHLW. However, no explanation could be obtained—even at the operational level—regarding the inconsistency between this claim and the MHLW’s own explicit denial of having made such a public announcement.

Given that this discrepancy cannot be resolved through verbal confirmation, the company judged that the justification for the non-disclosure decision itself remains questionable. Therefore, on June 15, 2026, it filed an administrative review request seeking the cancellation of the Consumer Safety Division’s non-disclosure decision (Shoanzen No. 184).

The Company’s Assessment

The division’s staff provided a careful explanation regarding the source of the materials. However, the fact that even frontline personnel could not explain the inconsistency with the MHLW’s own statements suggests to the company that the basis for using the term 'puberulic acid' within the Consumer Safety Division may not be sufficiently organized at the institutional level.

This release covers only the portion related to the Consumer Safety Division, as part of three administrative review requests filed against divisions within the Consumer Affairs Agency. Reports on the Food Labeling Division and the Food Hygiene Standards Review Division will be released separately. The company will continue to verify and document the facts of this case and will disclose additional information as necessary.