‘Benikoji’ Supplements: Utilize Lessons Learned to Improve Quality Control

Editorial

15:29 JST, March 26, 2025

Supplements that people continued to take believing that they were good for their health were manufactured under unsanitary conditions, resulting in serious health problems. The lessons learned must be utilized to improve the quality control of various health foods.

Kidney disease and other damage was caused to the health of some people who took supplements containing “benikoji” red rice mold, a food product with function claims manufactured by Kobayashi Pharmaceutical Co. In response, the Osaka municipal government has compiled the results of an on-site inspection of the factory and interviews with the people involved. A report was submitted to the Health, Labor and Welfare Ministry.

According to the report, blue mold that caused the health hazard may have entered through cracks in the culture tank of the benikoji. It is believed that the failure to fully recognize the danger of blue mold entering the tank may have caused the damage.

It can be said that sloppy sanitary management has caused serious consequences.

This incident has led to further research, which confirmed that the intake of “puberulic acid,” a natural compound produced by blue mold, can lead to serious kidney dysfunction.

It is hoped that the health food industry will make the dangers of blue mold well known to those in the workplace and hasten inspections of the manufacturing process.

A total of over 2,700 people have undergone medical examinations after taking Kobayashi Pharmaceutical’s supplements. Although it is unclear whether taking the supplements was the direct cause, 100 or more deaths are suspected to be related to their ingestion.

Kobayashi Pharmaceutical was aware of the health hazard in January last year, but the company did not report it to related administrative bodies or make a public announcement until two months later. It is obvious that the delayed response resulted in the spread of the damage.

It must be said that the company disregarded the safety of consumers. The company needs to change its corporate culture and sincerely deal with not only the burden of medical fees but also compensation for victims.

The central government’s guidelines for foods with function claims required that suppliers promptly report health damage to the government if they become aware of it. However, this was not mandatory, and it was also unclear at what stage such reports should be made.

In response to a spate of problems, reporting became mandatory in September last year, and any critical cases must be reported within 15 days. Penalties were also established to prohibit operations and sales if the guidelines are violated.

Starting next year, the manufacturing process will be required to have strict controls comparable to those for pharmaceuticals. Supplements are pills containing specific concentrated ingredients, and they are generally taken repeatedly. Once a health hazard occurs, the impact will be significant. It will be essential to strengthen safety measures.

Supplements are not meant to cure illnesses the way that drugs do. Rather, they are merely foods to supplement one’s health. It is important for people with chronic diseases to not misunderstand that point and to consult with a doctor before using them.

(From The Yomiuri Shimbun, March 26, 2025)