In the wake of various health damage caused by Kobayashi Pharmaceutical Co.'s "beni-koji" red yeast rice dietary supplements, the Japanese government has drawn up measures to prevent a recurrence. Yet their content is of a mere stopgap nature, raising the need to go one step further in setting forth measures to improve the safety of health food products in general.
The beni-koji supplements were products with claimed active health benefits, specifically in lowering cholesterol levels. Following an investigation, it was confirmed that substances derived from blue mold, which were mixed into the supplements, were responsible for causing renal disorders. Inadequate hygiene management at the production stage is considered to have been a problem. After the company's report to the government was delayed, the health damage spread further, resulting in the deaths of five people and hospitalization of more than 280.
In response, it was decided to require businesses to report to public health centers and other institutions when there is information regarding suspected health damage. If they neglect to file reports, they will be slapped with business suspension orders and other punishments.
In producing dietary supplements, manufacturers will be required to follow Good Manufacturing Practices (GMP), a guideline for production and quality control, on par with those for medicinal products.
The government introduced the system for foods with functional claims in 2015 as part of its deregulation measures. Manufacturers only need to report to the government to make those claims, without having to undergo state screenings. Many of the operational rules for the system are set under its guidelines.
Safety measures had basically been left up to businesses, and so it is reasonable to bolster them through laws and regulations. To make the safety steps effective, it is necessary to clarify the scope of reporting and deadlines, as well as the method for announcements. It is also imperative for the government to check whether companies are abiding by GMP.
The recurrence prevention measures, however, only target foods with functional claims.
There are other food products claiming health promotion effects, such as food for specified health use, known as "Tokuho," and food with nutrient function claims. In addition, what are dubbed "health foods" that fall outside these categories are also circulating in large quantities. There are numerous supplements with efficacy claims devoid of scientific evidence, which could be mistaken for medicinal products. Some of these products have caused serious health problems in the past.
In major countries in the European Union, North America and Southeast Asia, comprehensive regulations are set for supplements for their quality control and labeling, by setting them apart from general food products. This is because those supplements carry great risks from overdoses and other misuse.
In Japan, too, steps to enhance the safety of health food items as a whole should be taken. Some countries adopt a system requiring permission for the production of supplements using ingredients other than those listed as usable. In-depth discussions should be made by referencing these examples abroad.
If the Japanese government considers health food as a growth industry, then it bears the responsibility to develop a system that can win consumer confidence.
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