Death toll linked to Japanese supplements suddenly rises to 80

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

The company, Kobayashi Pharmaceutical, had reported five deaths in March that were possibly linked to its CholesteHelp rice and red yeast pills. Japanese health officials said the supplement, which claimed to help lower cholesterol, contained puberulic acid, a highly toxic substance that is a product of fungi.

Commenting on the sudden increase in reported deaths, Health Minister Keizo Takemi said it was “extremely regrettable” that Kobayashi Pharmaceutical had not informed the ministry earlier. The Osaka-based company had not provided any new information on deaths possibly linked to CholesteHelp since March.

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

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

Kobayashi Pharmaceutical was founded in 1919. Although not one of Japan’s major 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 regarding supplements and other products that make health claims were established in Japan in 2015. These regulations are considered less strict than Japan’s prescription drug regulations. Companies are typically responsible for self-reporting rather than state screenings.

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

At a press conference in March when the possible CholesteHelp-related deaths were first announced, Kobayashi Pharmaceutical President Akihiro Kobayashi apologized for not providing information sooner, saying he had “no words.”

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