Kobayashi Pharmaceutical Company's health products containing red yeast ingredients have caused consumer deaths and health damage, causing social unrest in Japan. Industry insiders point out that the red yeast incident reflects not only the production management issues of Kobayashi Pharmaceutical, but also the deficiencies in Japan's food safety management system. Since Kobayashi Pharmaceuticals announced a recall of problematic products on March 22, the investigation results announced so far are still limited. According to data from the Central Research Institute of Kobayashi Pharmaceutical, the red yeast polyketone in red yeast can reduce low-density lipoprotein cholesterol in the blood. The pharmacological active substance that plays a role in red yeast polyketone is mainly Monacolin K, which has the same structure as the commonly used lipid-lowering drug Lovastatin. Lovastatin is defined by the World Health Organization as a drug, but it has not yet been approved as a drug in Japan. It can be seen that Xiaolin Pharmaceutical's red yeast health products are nominally food, while the active ingredients are actually drugs. Japanese pharmaceutical industry insiders believe that Kobayashi Pharmaceuticals should be aware of the difficulty of drug approval, but use the name of red yeast polyketone to functionally label food sales and avoid drug approval. Experts and insiders also pointed out that the red yeast incident is closely related to Xiaolin Pharmaceutical's bad corporate style. From 2010 to 2011, Xiaolin Pharmaceutical conducted its first clinical trial, but there was a scandal of data tampering. The red yeast raw materials that have been exposed this time are all produced by Kobayashi Pharmaceutical's Osaka factory. Last year, employees of this factory made operational mistakes, resulting in over 30 kilograms of powdered raw materials being spilled on the floor, with some of the materials being recycled and still used for production. The public opinion also believes that behind the red yeast incident, there are not only production management and corporate ethics issues of Kobayashi Pharmaceutical, but also deficiencies in Japan's food safety management system. Health products containing red yeast ingredients belong to functional labeling foods and are one of the three types of health functional foods in Japan. Manufacturers can indicate health functions on product packaging without the need for regulatory approval. They only need to evaluate the safety and functionality of the product in accordance with regulations, and file with the Consumer Department under the Cabinet Office 60 days before listing. Some Japanese media believe that the functional label food system focuses too much on economic growth and reduces the burden on producers, at the cost of sacrificing consumer health. To eliminate public anxiety and distrust towards healthy food, fundamental reforms must be carried out on relevant systems. (Lai Xin She)