2 Deaths Among Users of Kobayashi Pharmaceutical Supplements; Osaka City Government Issues Recall Order

The Yomiuri Shimbun

16:50 JST, March 27, 2024

Two people died and 106 have been hospitalized in connection with health problems in people who ingested dietary supplements containing Kobayashi Pharmaceutical Co.’s benikoji red rice yeast, the health ministry announced Tuesday night.

The information was provided to the ministry by Kobayashi Pharmaceutical, which has received approximately 3,000 complaints or inquiries regarding the issue.

The Osaka municipal government on Wednesday issued a recall order to the Osaka-based company under the Food Sanitation Law for three products containing the substance suspected to be hazardous. This is the first administrative action to be taken over the red yeast issue.

The Osaka government was set to order Kobayashi Pharmaceutical to discard the products following the recall order. The three products are Benikoji CholesteHelp, Naishi-help plus cholesterol and Natto-kinase sarasara-tsubu gold.

The Health, Labor and Welfare Ministry on Tuesday night concluded that these products, which Kobayashi Pharmaceutical voluntarily recalled on Friday, were suspected of containing harmful substances and asked the Osaka municipal government to take action.

The health ministry was to hold a liaison meeting with the Consumer Affairs Agency and other relevant ministries and agencies on Wednesday to share information on the harm caused and discuss response measures.

Kobayashi Pharmaceutical announced on Tuesday that one person had died while hospitalized for kidney disease in February. This person had regularly purchased Benikoji CholesteHelp supplements from April 2021 to February 2024. The person’s gender and age have not been disclosed.

A Kobayashi Pharmaceutical official revealed another person’s death to a hearing held by the health ministry and Consumer Affairs Agency on Tuesday. The frequency of ingestion and other details regarding this person are unknown, but their doctor had reportedly noted kidney damage.

Kobayashi Pharmaceutical on Tuesday withdrew its “functional food” labeling for Benikoji CholesteHelp and seven other products, including some that were scheduled to go on sale.

Kobayashi Pharmaceutical supplies red yeast as an ingredient to 52 companies, including beverage and seasoning manufacturers. About 30 of these companies have announced voluntary recalls of products such as supplements, sake, miso and confectionery products.

The substance with a high possibility of posing a health hazard is contained only in red yeast for supplements and not in red yeast for foods, according to Kobayashi Pharmaceutical.

Benikoji CholesteHelp was put on the market in February 2021, and approximately 1.1 million units have been sold. The substance in question was found to be contained in supplements manufactured between July and October 2023.