The Japanese government’s confirmation that a toxic substance found in red yeast rice supplements produced by Kobayashi Pharmaceutical Co could cause kidney damage might help the supplement’s consumers in Taiwan if they seek compensation, the Food and Drug Administration (FDA) said on Wednesday.
The Japanese Ministry of Health, Labour and Welfare on Tuesday announced that toxic puberulic acid found in Kobayashi’s dietary supplements can cause renal tubular necrosis, citing animal experiments.
Officials from the ministry said they suspect that blue mold, which generates the acid, was accidentally mixed in during the cultivation of red yeast rice at the factory.
Photo: AFP
However, the acid’s effects on kidney function with repeated low dosages are yet to be determined, it said.
There have been a total of 64 reports of adverse reactions in people who consumed red yeast rice-related products from Kobayashi, according to the FDA.
FDA Deputy Director-General Lin Chin-fu (林金富) said that domestic complaints have all been transferred to consumer protection agencies for assistance.
With the Japanese ministry’s finding, if investigations point to legal liability on the part of Kobayashi, compensation claims would be easier to file, Lin said.
Taiwan is currently unable to test for puberulic acid due to a lack of specimens and testing methods, which Japan has not provided despite requests to do so, he said.
He said that related products in Taiwan were removed from shelves in late March.
According to the Japanese ministry, as of Monday, five people in Japan had died from consuming the supplements, with 281 others being hospitalized.
Asked about the matter, toxicologist Yen Tzung-Hai (顏宗海) via telephone said that little is medically known about the acid, including its acceptable daily intake, half-life and metabolic mechanisms.
However, he said that no puberulic acid should be detected during the standard fermentation process of red yeast rice products if standard operating procedures are followed.
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