Death toll linked to Japanese dietary supplement suddenly climbs to 80

A Japanese pharmaceutical company is investigating 80 deaths possibly linked to a yeast-containing supplement it sells in Japan, the country’s health ministry said Friday, a shocking increase from an earlier revelation that drew attention to how supplements are regulated.

Kobayashi Pharmaceutical Company reported five deaths in March that were potentially linked to its CholesteHelp red yeast and rice pills. Japanese government health officials said the supplement, which was supposed to help lower cholesterol, contained a highly toxic compound called puberulic acid, a product of mold.

In response to the sudden increase in the number of reported deaths, Health Minister Keizo Takemi said it was “extremely regrettable” that Kobayashi Pharmaceutical had not informed the ministry sooner. The company, based in Osaka, had not provided new information on deaths potentially linked to CholesteHelp since March.

Since then, Kobayashi Pharmaceutical has received reports that 1,656 people have sought medical attention for health problems related to CholesteHelp, and 289 people have been hospitalized, the company reported. CholesteHelp was recalled in Japan and China, the only countries in which the supplement was sold, according to a Kobayashi Pharmaceutical spokeswoman.

Mr Takemi said the government would step in to take a more active role in the investigation, after allowing the company to report its findings itself. “We can no longer leave Kobayashi Pharmaceutical to handle this alone,” he said.

Kobayashi Pharmaceutical was founded in 1919. While not one of Japan’s largest pharmaceutical companies, it produces a variety of supplements and health products such as hand warmers and air fresheners, some of which are sold in the United States and elsewhere in Asia.

Quality control guidelines related to supplements and other products making health claims were established in Japan in 2015. These regulations are seen as less strict than Japanese rules governing prescription drugs. Companies are generally responsible for their compliance rather than subjecting themselves to state controls.

In the United States, where the dietary supplement market is booming, organizations such as the American Medical Association have urged the Food and Drug Administration (FDA) to implement stricter rules to ensure the safety of dietary supplements. Dietary supplements marketed for weight loss and muscle building have been linked to a number of deaths in the United States.

At a press conference in March, when the deaths potentially linked to CholesteHelp were first revealed, Kobayashi Pharmaceutical President Akihiro Kobayashi apologized for not providing information sooner and declared that he had “no words”.

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