The health problems caused by health foods containing benikoji (red rice malt) that arose in 2024 resulted in numerous serious injuries. This incident further undermined trust in health foods and supplements as a whole, reaffirming the importance of ensuring their safety. It also highlighted various issues regarding crisis response by companies and governments and the approach of consumers to health foods. The cause of the incident was a mold product introduced during the manufacture of red koji, and flaws in the inspection processes and labeling systems were also identified. Furthermore, the manufacturer's delayed initial response, including information disclosure and product recalls, due to a lack of appropriate medical advice, significantly exacerbated the damage. This review summarizes the history of the incident, discusses the system reforms that were implemented in response, and discusses the importance of collecting, analyzing, and providing feedback on health problems caused by health foods. While efforts to prevent recurrence are needed from industry, the government, medical professionals, and consumers, the newly established national government-led system for collecting and monitoring health problems is particularly promising.

Although health foods are widely used by the public, they can sometimes cause life-threatening health damage or leave serious after-effects. Health foods were originally intended to boost health in the absence of underlying illness, but in actual clinical settings, it is not uncommon for them to be taken by individuals with illnesses. As damage to health caused by such foods has sometimes been documented in the form of case reports, analysis of such cases in an organized database might be of help for understanding their characteristics. Analysis using the Shourei-kun search system as a domestic database on the website of local meetings of the Japanese Society of Internal Medicine and the Japan Endocrine Society has suggested that if health damage occurs in individuals with certain comorbidities, the outcome may be severe. Analysis using PubMed as an overseas database also revealed several cases with a fatal outcome. These findings suggest that individuals with illnesses need to be careful to avoid serious health damage resulting from the use of health foods.

The role of “health foods” is to maintain and promote good health status by providing nutrients that are in short supply. On the other hand, the use of some commercial products is associated with certain risks. In order to prevent and minimize health problems associated with the consumption of “health foods”, it is important for regulatory agencies to quickly detect any signs of such risks. For this purpose, it is essential to have a system for reporting health problems related to these products. Some of these health problems are not necessarily limited to serious cases, and many are not reported because the symptoms are mild. This means that some health problems tend to remain hidden. However, the ongoing revision of the current system for reporting health problems has steadily improved its effectiveness. Furthermore, public health centers have been playing a central role by identifying health problems in the community and taking initial action, thus supporting the reporting system. However, public awareness of the role of these health centers is not always sufficient, which may make it difficult to quickly share information about health problems among relevant parties. Therefore, in this article, we describe the role of public health centers and the importance of social awareness for preventing the adverse effects of health foods.

Foods with Functional Claims system has been in place for ten years since its inception, during which the market size has expanded remarkably. However, following recent administrative orders related to health damage incidents, including issues arising from Kobayashi Pharmaceutical's red yeast rice products, consumer trust has been shaken. In response, the Consumer Affairs Agency promptly revised the system, further strengthening its legal framework. The Japan Alliance of Health Food Associations (JAOHFA), a general incorporated association, aims primarily to consolidate the opinions of various organizations related to health foods and to make proposals to the government. The JAOHFA is committed to developing voluntary standards and improving system operations. Through subcommittee and committee activities, the JAOHFA has promoted public relations and established industry standards, with around 200 members participating. In particular, the Safety Subcommittee places strong emphasis on the responsibilities of business operators regarding changes in physical condition and health damage, aiming to restore consumer trust. Moving forward, the JAOHFA will continue to propose improvements to the system, establish industry self-regulatory standards, and promote awareness activities, with the goal of enhancing consumer satisfaction. Furthermore, the JAOHFA plans to strengthen collaboration with external parties and incorporate expert knowledge to ensure the reliability of the system. Through these proactive efforts, it is expected that the healthy development of the industry and consumer safety will be further secured.

In order to take immediate steps to prevent any recurrence of the health damage caused by beni-koji-related products that occurred in March 2024, a meeting of relevant cabinet ministers was held on May 31, 2024, to formulate “Future Responses Regarding the Functional Food Labeling System”. Based on this policy, in order to make it mandatory for notifiers of Foods with Function Claims and licensees of Foods for Specified Health Uses to promptly provide information to prefectural governors, etc. when they receive information concerning any possible occurrence or spread of health damage related to such products, along with amendment of Food Labeling Standards, we have made partial amendments to the Regulations for Enforcement of the Food Sanitation Act.