Government Review of Health Product Approval System in Japan: Lessons Learned from Kobayashi Pharmaceutical Scandal

In response to a recent investigation into dietary supplements and their potential link to illnesses, the Japanese government has ordered a review of the approval system for health products. This move follows reports of deaths and hospitalizations linked to supplements produced by Kobayashi Pharmaceutical, which advertised their products as lowering cholesterol.

A factory belonging to Kobayashi Pharmaceutical in Osaka was inspected by officials from the ministries of health, labor, and welfare, along with local authorities. The supplements in question contained an ingredient called red yeast rice or “beni koji.” The company reported five deaths and 114 people being treated in hospitals after taking the products. The Ministry of Health in Japan has attributed these incidents to the supplements and has warned that more people could be affected.

The cause of the illnesses is still under investigation in collaboration with government health authorities. However, reports of health issues related to “beni koji” have been around since 2023, although it has been used in various products for years.

Kobayashi Pharmaceutical has recalled the health supplements containing red yeast rice and apologized for not acting sooner. These supplements were available without a prescription at pharmacies, with about a million packages sold over the past three fiscal years. Some products were also exported to countries like China and Taiwan.

The government’s review of the approval system for health products is ongoing, with a report expected in May. A Chinese consumers association has also advised consumers to stop using Kobayashi products due to concerns about potential risks.

In conclusion, this incident highlights the need for better regulation and oversight of dietary supplements before they are approved for public use. The government’s decision to review the approval system for health products is commendable as it will help prevent such incidents from happening again in the future. Consumers must exercise caution when purchasing dietary supplements and always consult with healthcare professionals before taking any new medication or supplement regimen.