A factory of Kobayashi Pharmaceutical Co, is seen in Osaka, Japan on March 26, 2024. (PHOTO / AP)

A health crisis involving Kobayashi Pharmaceutical dietary supplements containing an ingredient known as red yeast rice, or “beni-koji”, has sparked growing concern among consumers both inside and outside Japan. 

The Osaka-based drugmaker has reported five deaths and more than 110 hospitalizations linked to such products. Individuals affected reportedly experienced kidney problems and other health issues. Additionally, nearly 700 others have either sought medical attention for health concerns or expressed a desire to do so. 

Furthermore, according to statistics from the Taiwan food and drug administration, a system for reporting unexpected reactions to health food, tablets, and capsules in Taiwan has received 11 reports related to Kobayashi Pharmaceutical red yeast rice products, the Central News Agency reported on Monday. 

Kobayashi Pharmaceutical said it is investigating a potential link between its products and their effects on kidney function. It has initiated a recall of the supplements marketed to lower levels of low-density lipoprotein cholesterol, or “bad” cholesterol, and started accepting returns on Monday. 

On Sunday, Japan’s Ministry of Health, Labour and Welfare, along with Wakayama prefecture authorities, conducted an on-site inspection of a Kobayashi Pharmaceutical subsidiary’s plant in Kinokawa, Wakayama prefecture. This followed a similar administrative inspection of the parent company’s Osaka plant on Saturday. The Osaka plant was closed in December 2023 due to aging facilities, prompting production to be shifted to the Wakayama facility from January. 

Despite being a large company, some consumers have expressed concerns about trusting Kobayashi Pharmaceutical amid this uncertainty. 

Japan’s health ministry said the company has confirmed the presence of puberulic acid, an unintended substance, in its products. However, the ministry said it remains unclear whether this substance is directly responsible for the reported deaths and hospitalizations. 

To address consumer worries and minimize the impact on unrelated products containing red yeast rice, the health ministry disclosed the names of 173 businesses supplied with Kobayashi Pharmaceutical’s red yeast rice ingredients. 

These companies have been urged to conduct voluntary inspections for any reported health issues within the past three years. 

Moreover, red yeast rice from Kobayashi Pharmaceutical has been used in various products such as confectionery, bread, alcohol, and miso. 

The Asahi Shimbun, one of Japan’s largest national daily newspapers, emphasized the urgent need for explanations regarding the safety and response strategies concerning such products. 

In light of the seriousness of the situation, an editorial published by the newspaper on March 29 stressed the significant responsibility of business operators and called for prompt investigation to prevent the spread of damage. 

Criticisms have been raised regarding the timeliness of information provision, with the company’s awareness of the issue in mid-January contrasted against its report to the government in late March. 

Kobayashi Pharmaceutical’s recalled “Beni-koji Choleste Help” supplement falls under the category of “foods with function claims”, or FFC. 

These foods are not subject to the government review of safety and functionality. Instead, it is the food business operator’s own responsibility to label products with function claims based on scientific evidence. The FFC system was introduced in 2015 as part of the Shinzo Abe administration’s growth strategy. 

As a result, Japan’s domestic FFC market has been growing annually. It is forecasted to exceed 700 billion yen ($4.62 billion) this year, up from 31.4 billion yen in 2015, according to market research company Fuji Keizai. 

Despite their growth in Japan’s domestic market, concerns have arisen regarding the oversight of FFC products. 

According to Japan’s Consumer Affairs Agency, the agency promptly requests businesses update their information if there are any changes. It also requests that information regarding whether products are being sold be updated approximately every six months. 

However, an analysis by Tokyo Shoko Research as of March 27 revealed that out of the 6,749 FFC products currently registered, information for 982 products — or 14.5 percent of the total products — has not been updated for at least six months. 

The Consumer Affairs Agency has instructed a reevaluation of all FFC products but it is necessary to reconsider whether it is appropriate to leave safety confirmation solely to the business operators, said the editorial by The Asahi Shimbun.

Contact the writer at jiangxueqing@chinadaily.com.cn