Kobayashi Pharmaceutical Slow to Deal With Fatal Supplements; Announcement Came More Than 2 Months After Problem Discovered

By Hiroyuki Kume and Yuiko Sakashita / Yomiuri Shimbun Staff Writers

15:35 JST, March 27, 2024

It took more than two months after Kobayashi Pharmaceutical Co. found out some of its supplements had a harmful effect to inform the public of the situation.

Two consumers who took the supplements containing benikoji red yeast-fermented rice were found to have died from kidney disease. The number of hospitalized purchasers — which was initially announced as six — has ballooned to more than 100, making it difficult to foresee how far the damage will spread. The company’s handling of the situation has also been questioned.

On Friday, Kobayashi announced that it was voluntarily recalling its Benikoij CholesteHelp (Red yeast cholesterol help) supplement. Since then, a series of phone calls and emails have been received from people complaining of symptoms, and from doctors who have treated them.

As of Monday, 3,600 such messages had been received by email alone, and the number of people complaining of health problems is expected to grow further.

Kobayashi supplies red yeast to 52 companies, mainly food manufacturers. Currently, only its red yeast supplements have been reported to cause health problems, but this may spread to other products in the future.

‘Unsure of cause’

Kobayashi has been slow in handling the problem. It was Jan. 11 when the company received a call from a person complaining of kidney disease symptoms, but the company did not make a public announcement until Friday.

The maker first suspected the presence of citrinin — an ingredient that causes health problems — in its product. Citrinin is contained in some red yeast, and a doctor who treated one of the patients said it could be the cause.

Although Kobayashi had selected and cultured a yeast strain that does not produce citrinin, it analyzed the supplements just to be sure. No citrinin was detected.

It then looked into patients’ allergies and the effects of the supplements in combination with other supplements, but could not determine the cause. However, after interviewing people who complained of health problems, it learned that they took the products around the same time. Kobayashi then narrowed its investigation to supplements manufactured during a certain period and detected an unintended ingredient from the samples.

“At first, we could not be sure that our product caused the problem,” Kobayashi executive officer Jun Watanabe, in charge of quality control, said at a press conference on Friday, “We had a limited number of people whom we could investigate.”

The 52 companies that were buyers were also not informed until after Friday. Meanwhile, Kobayashi had not informed the Health, Labor and Welfare Ministry or Osaka City of the problem because the cause had not been identified.

Hurrying to identify ingredients

Kobayashi is now investigating the cause of the problems. The production building for red yeast at the Osaka factory, which closed in December, had required that all items brought into the factory be checked, and that multiple people be working together. “It’s highly unlikely that a third party introduced the foreign substance,” a supervisor said.

Under the circumstances, Kobayashi believes there is a strong possibility that an unintended ingredient produced by the mold for some reason caused the health hazard. The company is currently working with several university laboratories to identify the ingredient and hopes to disclose the cause in one to two months.

“It probably took some time because hazardous citrinin was not detected,” said Gifu Pharmaceutical University Prof. Kiyoyuki Kitaichi, who also is the chairman of Japanese Association of Food Science and Risk Analysis. “Considering the magnitude of the impact, the company could have consulted with the government at an early stage before the public announcement.”

Kobayashi Pharmaceutical was founded in 1886 and now employs about 3,500 people. Its mainstay products are over-the-counter pharmaceuticals and sanitary items, with its hit items including an anti-inflammatory pain reliever, a toilet air freshener and a liquid aromatic deodorizer.

It had consolidated net sales of ¥173.4 billion and a final profit of ¥20.3 billion for the fiscal year ending December last year.