Metropolis Japan

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Five deaths and the hospitalization of almost 200 people in the six months since September last year have been linked to the use of dietary supplements containing red yeast rice, prompting demands for stricter safety regulations on food products with functional claims.

These products were produced by about 170 different companies that used red yeast rice “beni koji” supplied by Kobayashi Pharmaceutical Co and were promoted as helping to lower cholesterol levels. Tests on batches produced last year showed high levels of pubic acid, a naturally occurring compound that comes from blue mold and can be highly toxic.

Red yeast rice is the product of yeast grown on white rice, and the powdered yeast-rice mixture is a basic ingredient of the diet in East Asia, also long used in traditional Chinese medicines. Studies have shown it to be helpful in lowering cholesterol levels, although the Mayo Clinic report also details a number of potential side effects, including liver damage and muscle disorders.

The National Institutes of Health Sciences continues to analyze product ingredients and is still working to determine how the mold entered the manufacturing process.

Many questions remain unanswered, and the scandal has cast a shadow over the entire dietary supplement sector, raising questions for companies that supply raw materials, produce final products, and government agencies that are supposed to monitor the safety and effectiveness of products sold to the public.

Osaka-based Kobayashi Pharmaceutical issued a comprehensive apology, and on May 10, executive director Yumi Nakagawa issued a statement apologizing for “serious concerns and concerns” about the tainted products.

“We pray for the souls of the tragically deceased and express our sincere condolences to their families,” he added in a statement.

However, questions remain as to why the company voluntarily recalled five products containing tainted red yeast rice only on March 22, about two months after the company discovered the link to the health complaints. According to the Japanese Society of Nephrology, complaints mainly concern damage to consumers’ kidneys.

Media reports claimed that a 32-year-old man taking supplements was diagnosed with kidney function comparable to a man in his 80s to 90s.

Even after the company’s apology, it took another eight days for the health ministry and Osaka city government officials to inspect the company’s manufacturing facilities in Osaka.

There is also growing pressure on the government over how defective products will be sold and what action will be taken to ensure this does not happen again.

Regulations on food products that manufacturers claim have health benefits were relaxed in 2015, only requiring manufacturers to submit their own assessment of safety and effectiveness before putting them on the market. Therefore, products in this category have not been subject to inspection by public health authorities.

According to the Consumer Affairs Agency’s guidance on foods with functional claims, it is “strongly desirable” that products are subjected to quality control measures equivalent to those for medical products. No such measures have been implemented at Kobayashi Pharmaceutical’s plant in Osaka.

Lax requirements, combined with the fact that these products are available without consulting a doctor, have also raised concerns that they could lead to accidental overdoses among users.

The Mainichi newspaper reported that as many as 7,000 functional food products are now available in Japan, six times the number of food products requiring government control of their health and safety properties. The value of the functional food market is estimated at 680 billion yen per year.

On April 8, 2024, the Mainichi editorial board demanded action, stating: “It is unacceptable for health food products to ruin people’s health.”

The article called on manufacturers to work with the government to implement effective safety measures, adding: “When health problems arise, the consequences can be enormous.”