Benikoji Supplement: Important Information was Disclosed Too Slowly

A situation in which important information was not disclosed promptly, even though harm to people’s health was spreading and some even died, cannot be overlooked. To prevent further harm, there must be thorough disclosure of information.

When Kobayashi Pharmaceutical Co. analyzed its supplement made with benikoji red rice mold that has caused health problems, it detected puberulic acid, a substance produced by blue mold.

Puberulic acid is considered highly toxic, but its effect on kidneys — which have been involved in a number of cases of health problems — is not known. Relevant authorities need to do everything they can to determine the cause of the problems.

Kobayashi Pharmaceutical reported the detection of puberulic acid to the Health, Labor and Welfare Ministry on March 28. However, at a press conference on the following day, March 29, the drugmaker initially said only that it was an “unknown substance.”

During the press conference, Kobayashi Pharmaceutical hastily admitted the detection of puberulic acid because the ministry had separately disclosed the name of the substance. President Akihiro Kobayashi explained, “We were unable to make a decision on our own.” It must be said that the company has lacked a sense of crisis in its response to a problem that could affect human lives.

Kobayashi Pharmaceutical has been noticeably slow to respond to the problems since the initial phase. It was aware of the problems in mid-January but did not make a public announcement or report to relevant government ministries and agencies, including the health ministry, until more than two months later.

The company has said “it took time to determine the cause,” but if such thinking goes unchallenged, there will be no need to announce anything until the cause of a problem is definitively identified. If the company puts consumer safety first, it should not have responded in this way.

On Feb. 1, a doctor at Nihon University Itabashi Hospital who examined three patients with kidney problems and suspected that the supplement might be the cause reported that to Kobayashi Pharmaceutical. However, it was reportedly not until three weeks later that a person in charge from Kobayashi Pharmaceutical visited to listen to the doctor about the situation.

The supplement in question is a food with function claims. This means that if the manufacturer notifies the Consumer Affairs Agency in writing of its claims, it does not need to have the product screened by the central government and can sell it while stating the health benefits. However, guidelines established by the agency require manufacturers to promptly report information about harm to people’s health, even if it has not been sufficiently proven.

As long as it is a health product, it is reasonable that upon receiving information about harm to people’s health, Kobayashi Pharmaceutical should notify relevant ministries and agencies of the information and discontinue sales of the product.

The impact of the situation has also reached overseas, with health problems involving benikoji reported in Taiwan.

The health ministry and the Osaka municipal government conducted an on-site inspection of the factory where the product was manufactured. Puberulic acid was reportedly detected in benikoji ingredients manufactured at the Osaka plant between April and October last year.

The Osaka factory was closed in December, but it is important to investigate the health problems from multiple angles, including whether there was anything that led to blue mold being produced in the equipment and elsewhere, and whether there was any danger of it entering the factory from outside.

(From The Yomiuri Shimbun, April 2, 2024)