There has been widespread damage caused by Kobayashi Pharmaceutical Co.’s dietary supplements containing “beni-koji” red yeast rice to the health of people who ingested them. Fatalities have also been confirmed, becoming the first such cases in Japan involving food products with functional claims.

It is unacceptable for health food products to end up ruining people’s health. Let us take this opportunity to ponder what safety measures should be taken.

The system for food products with functional claims was introduced in 2015 as part of Japan’s growth strategy. Regulations were relaxed for those products compared to food for specified health use, known as “Tokuho,” which requires the national government’s screenings. Manufacturers only need to submit safety and efficacy evaluations to advertise their products as those with functional claims, making it easier for them to enter the market.

The health issues that erupted among beni-koji supplement users have brought the challenges faced by this system into sharp relief.

First, there is the question of whether the production process for the supplements in question had been properly managed. Puberulic acid, an unintended substance, has been detected in some of the ingredients of the supplements, raising the possibility that blue mold had been mixed in.

The Consumer Affairs Agency’s guidelines stipulate that food products with functional claims are “strongly desired” to be managed under quality controls equivalent to those for medicinal products. However, such a system was not in place at the Osaka factory where the beni-koji supplements were produced.

The drugmaker’s response after receiving reports on health hazards was also fraught with problems. Kobayashi Pharmaceutical explained that it took time to investigate the cases, but more than two months had passed since the company became aware of the first case of health damage in mid-January before it reported the issue to the national government.

The Food Sanitation Act does not require reports on cases where the causative substances have yet to be identified, and this has also contributed to the delays in the drugmaker’s announcement and product recalls.

Unlike medicinal products subject to strict legal regulations, the labeling of product efficacy of food with functional claims is also largely left up to suppliers. While it is illegal to advertise therapeutic effects like those of drugs, manufacturers can pitch their products with eye-catching blurbs such as the product “makes it difficult to put on body fat” and “curbs blood sugar rises.”

Because these products are available without doctors’ or pharmacists’ guidance, there are risks of overdose among users.

There are around 7,000 food items with functional claims, more than six times as many as Tokuho products. The former’s market has grown to an estimated 680 billion yen (approx. $4.5 billion) in size, and it is expanding overseas. Once health problems arise, their repercussions can be enormous.

The Consumer Affairs Agency has launched a team to discuss the future shape of food products with functional claims. The team plans to offer a directive by the end of May.

This is an issue directly connected to the public’s health. It is essential to develop a system to allow people to ingest these food products without worries.