Foods with Function Claims: Require Prompt Reporting by Firms at First Sign of Health Problems

There is a plethora of food products claiming health benefits. How to ensure safety is an important issue. Rules must be put in place to ensure a prompt response in the event of health problems.

A number of people have developed kidney problems after taking a supplement made with benikoji red rice mold, a food with function claims manufactured by Kobayashi Pharmaceutical Co. So far, five people have died and more than 200 have been hospitalized.

Foods with function claims can be marketed while stating health benefits, even without screenings by the central government, if materials serving as scientific evidence for the claims are submitted to the Consumer Affairs Agency. The system was introduced in 2015 as part of regulatory reform, and there are now over 6,800 such products.

The first problem behind the recent health damage is the delay in reporting it to relevant authorities. As long as the system leaves it to companies to assure health benefits and safety, there must be a mechanism to immediately take measures to halt the spread of damage if information on harm to health is found.

Kobayashi Pharmaceutical was aware of the problems in mid-January, but the company did not report them to the central and local governments until more than two months later.

The guidelines for foods with function claims established by the Consumer Affairs Agency state that if health problems occur, “it is appropriate to report them promptly even if the information is not definitive.” However, it is unclear at what stage such a report should be made. In addition, there is no legal obligation to do so.

Some people, unaware of any information on the health problems, continued to use the supplement even though they had been feeling ill. If Kobayashi Pharmaceutical had immediately shared the information with the central and local governments and called for the discontinuation of the product’s use, it would have been possible to prevent the damage from spreading.

Rules should be established to legally require companies to report regarding health problems, rather than leaving the decision-making to companies.

In the benikoji case, a toxic substance called puberulic acid, derived from blue mold, was detected in the ingredients that were reported to have caused the health problems. Although its relation to kidney problems is under investigation, this substance is not believed to be naturally generated by benikoji red rice mold, and it is suspected to have gotten into the product during the manufacturing process.

Supplements have high concentrations of specific ingredients and are used for long periods of time in many cases. For that reason, if they cause health problems, their effects on the body are greater than those of ordinary food products.

One idea would be to have a system in which manufacturers receive a third-party evaluation of their manufacturing process and quality control when they notify the Consumer Affairs Agency.

Regarding foods with function claims, there have often been issues with product labeling.

For example, last year, the agency issued an order to a sales company to stop displaying claims about lowering blood pressure on the labels of its supplements. This is because the agency judged that there was no reasonable evidence to support the effectiveness of the products.

The central government is now considering reviewing the system. It is hoped that a mechanism to check the validity of labeling will also be strengthened.

(From The Yomiuri Shimbun, April 11, 2024)