The issue of food safety is again in the news following reports that people died after ingesting a dietary supplement made by Kobayashi Pharmaceutical Co. that contains benikoji, a malted rice ingredient.
There is a bitter irony that the cases involve products advertised as helping to maintain and enhance health. This, of course, places significant responsibility on the pharmaceutical company. It is crucial to prevent additional cases and grasp the full scope of the matter as efforts get under way to investigate the cause.
The outbreak concerns three products registered as “kinosei hyoji shokuhin” (foods with function claims, or FCC) with the government, including “Benikoji coleste-help,” which were promoted for their ability to lower cholesterol levels. The FCC tag refers to food products labeled with specific health benefits based on scientific evidence.
The four deaths and more than 90 cases of hospitalization that have resulted are linked to consumption of the ingredients. These products are the subject of a recall based on the Food Sanitation Law as they are suspected of containing toxic or harmful substances.
Kobayashi Pharmaceutical’s benikoji ingredient was also supplied to other companies and used in snacks, bread, alcohol and miso. Benikoji, which translates as “red yeast,” is made by fermenting grains such as rice or barley with Monascus purpureus, a purplish-red mold, also known as ang-khak rice mold.
Although no health issues have been reported with these other products, manufacturers are voluntarily recalling them. It is imperative to offer clear explanations about their safety and plans to deal with any potential health risks they pose.
According to Kobayashi Pharmaceutical, an unexpected substance was found in some of the benikoji ingredients used in the supplements, but it has not yet been identified. Most of the cases of people falling sick occurred among individuals who consumed products produced after September last year, but it is unclear if the problem is limited to a specific time period.
The drug maker is responsible for investigating all of the facts related to the outbreak, but the government should not leave this solely to the company. It needs to get proactively involved in responding to the crisis by cooperating with national research institutions and other expert organizations.
The initial response after the matter came to light appeared to be slow and tepid. Kobayashi Pharmaceutical first became aware of the problem on Jan. 15, but did not report it to the government until March 21, the day before it was made public.
Some government officials have criticized the company for the delay in providing information. But food and drug regulators should also thoroughly verify whether there were any shortcomings in how they tried to assess the situation concerning health issues.
Kobayashi Pharmaceutical manufactures and markets a wide range of health-related products, and its advertisements are frequently seen. Assuming that consumers who trusted the advertised effects and safety of “Foods with Function Claims” suffered health issues from these products, the outbreak has serious implications.
The FFC labeling system was introduced in 2015 as part of the growth strategy when Shinzo Abe was prime minister. Unlike “tokutei hokenyo shokuhin (Tokuho)” (Foods for Specified Health Uses), which require governmental review for safety and efficacy, FFC labeling only requires businesses to submit certain information for approval.
Consumption of concentrated components like supplements on a daily basis could have a more significant impact compared to regular food.
The Consumer Affairs Agency has ordered a re-examination of all 6,800 FFC-labeled products, but it is worth questioning if the current FFC labeling system, which leaves safety confirmation to businesses, is acceptable from the viewpoint of public health and whether the system itself needs reconsideration.
--The Asahi Shimbun, March 29
