The Ministry of Health, Labour and Welfare said on the 18th that laboratory tests have confirmed that Kobayashi pharmaceutical company found Paecillic acid in the raw materials of health products containing Monascus is the cause of renal dysfunction in consumers, the other two“Unexpected” substances were not nephrotoxic.
According to the reports of the Kyodo News Agency, the Kansai Telecasting Corporation and other media, animal experiments conducted at the Japanese National Institute of research showed that only rats ingested paecillic acid showed renal dysfunction, the other two“Unexpected” substances had no negative effect on the kidneys.
The Ministry of Health, Labour and Welfare speculated that factories producing Monascus ingredients mixed penicillium with Monascus to produce paecillic acid. Two other“Unexpected” substances may be containing monacolin k, the active ingredient in Monascus health products, under the influence of Penicillium. Earlier, the Ministry of Health, Labour and Welfare and Osaka City of Kobayashi’s production of Monascus raw materials in the Osaka plant conducted on-site inspections, from the culture room and other places to extract penicillium. A factory in Wakayama Prefecture, home to a pharmaceutical subsidiary of Kobayashi, was also inspected.
In March, Kobayashi announced that some consumers had developed kidney problems after taking its health products containing red yeast, the company analyzed the health products containing Red Koji and the raw materials of Red Koji, and found that there were“Unexpected” ingredients in the raw materials of Red Koji, the company decided to recall all three products containing red yeast health products.
According to information previously published on Kobayashi’s website, the three products in question are red qu cholesterol granules, nattokinase granules and cholesterol-lowering health aid granules, all of which contain red qu, the main selling point is to lower cholesterol. For the Chinese market, Kobayashi said in a microblog post “Notice on stopping the use of Red Qu cholesterol pellets and voluntary recall.”, the products have been sold in Tmall Kobayashi overseas flagship store, Pinduoduo Kobayashi official overseas flagship store and Kobayashi overseas jd.com direct store.
The investigation confirmed that the presence of paeonitic acid in these Monascus raw materials. In addition to mucilaginous acid, but also detected two other“Unexpected” substances. According to the latest figures released by the Ministry of Health, Labour and Welfare, 2,450 consumers have sought medical attention after taking Kobayashi’s health products containing red yeast, and 120 deaths in the incident are being investigated for cause and effect.