Kobayashi scandal may impact 33,000 firms in Japan: investigation

The red yeast rice produced by the Japanese drugmaker Kobayashi Pharmaceutical, which is linked to certain health issues, may affect 33,000 enterprises in Japan including over 5,000 food and beverage retailers, according to a recent investigation by the Teikoku Databank.

The Osaka-based pharmaceutical had supplied red yeast rice raw materials to 225 companies, with some being sold directly and others being processed and resold, which may impact up to 33,000 enterprises in Japan, said the investigation.

Among these affected enterprises, food and beverage retailers make up the largest portion of 5,582, said the investigation, noting that 5,171 other retail enterprises, 3,884 medical enterprises, and 3,115 restaurants have also been affected.

The pharmaceutical has recalled multiple products including the "Beni-koji choleste-help" supplement, marketed for cholesterol reduction, after its dietary supplements containing red yeast rice, or "beni-koji," were potentially linked to adverse health events. As of Monday, five deaths and about 166 hospitalizations related to these products were reported.

'Health food' labeling system

The incident has raised significant concerns among the Japanese public over the country's classification of health-functional foods, particularly the labeling system introduced in 2015.

Japan used to categorize health-functional foods into two main groups: "Foods for Specified Health Uses" and "Nutrition Function Foods." In 2015, the Consumer Affairs Agency (CAA) of Japan launched the "Foods with Function Claims" (FFC) labeling initiative.

This new system permits companies like Kobayashi Pharmaceutical to independently evaluate and document the health benefits and functional attributes of their products prior to marketing, bypassing the need for approval from Japanese government authorities.

"The 'functional labeling food' by Kobayashi Pharmaceutical only requires submitting documents for registration, allowing the company to self-verify safety. This lacks objectivity and harbors risks. The so-called healthy foods are supposed to be good for the human body. But, if the ingredients are vague, without thorough investigation and analysis, similar issues could arise," a Tokyo resident told China Media Group (CMG).

Another Tokyo resident criticized Kobayashi Pharmaceutical's operational practices. "Kobayashi Pharmaceutical's management system is flawed. They might not have investigated initial reports seriously, leading to delayed public disclosure," he said.

Some voiced concern that major Japanese corporations put too much emphasis on economic gains at the expense of safety.

"As a leading pharmaceutical company in Japan, the Kobayashi Pharmaceutical has taken advantage of public concerns for healthy living to market their products as 'beneficial to health' to maximize profits. This has led to oversights that jeopardize consumer health. Moreover, the national approval system also has shortcomings of prioritizing corporate profits over stringent scrutiny," said another Tokyo resident.