A Japanese pharmaceutical company is investigating 80 deaths possibly linked to yeast-containing supplements it sells in Japan, the Ministry of Health, Labor and Welfare said Friday, a shocking increase from previous revelations that have drawn attention to how supplements are regulated.
Kobayashi Pharmaceutical reported five deaths in March that may be linked to its rice and red yeast pill “CholesteHelp.” Japanese government health officials said the supplement, which is said to be effective in reducing cholesterol, contained puvellic acid, a highly toxic compound produced by mold.
Health, Labor and Welfare Minister Keizo Takemi said it was “extremely regrettable” that Kobayashi Pharmaceutical had not notified the ministry sooner following the sudden increase in reported deaths. The Osaka-based company had not provided any new information on deaths suspected to be linked to Cholestehelp since March.
Since then, Kobayashi Pharmaceutical reported that it has received reports of 1,656 people seeking medical attention and 289 people being hospitalized due to health concerns related to CholesterolHelp. According to a Kobayashi Pharmaceutical spokesperson, CholesterolHelp is only being recalled in Japan and China, the only countries where the supplement was sold.
Takemi said the government would step in and conduct more aggressive investigations, after having the company self-report its findings. “We can no longer leave it up to Kobayashi Pharmaceutical alone,” he said.
Kobayashi Pharmaceutical was founded in 1919. Although it is not one of Japan's major pharmaceutical companies, it makes a range of supplements and health products, such as hand warmers and air fresheners, some of which are sold in the US and other parts of Asia.
Quality control guidelines for supplements and other products that make health claims were enacted in Japan in 2015. These regulations are perceived to be less strict than Japan's rules for prescription drugs, and companies are typically responsible for self-reporting compliance rather than undergoing government inspections.
In the United States, where the dietary supplement market is booming, groups such as the American Medical Association are calling on the Food and Drug Administration to introduce stricter rules to ensure the safety of dietary supplements, which are marketed for weight loss and muscle building and have been linked to a number of deaths in the country.
At a press conference in March when the deaths possibly related to Cholesterolhelp were first made public, Kobayashi Pharmaceutical President Akihiro Kobayashi apologized for not providing information sooner and said he was “at a loss for words.”