A recall of red yeast products linked to at least five deaths in Japan may have Americans questioning the safety of various dietary supplements that contain this ingredient and are readily available online and in stores.
The recalled product from Kobayashi Pharmaceutical, which is touted as a natural way to lower cholesterol, contains moss moss, an ingredient derived from a type of mold.
The Japan Times reported that the company announced at a press conference on Friday that a compound called puberuric acid had been detected in the recalled products and that it was investigating whether the substance could be linked to the fatal accident. . Kobayashi also said that the company's products are also exported to other countries such as China and Taiwan.
To date, no products containing red yeast rice have been recalled or linked to health issues in the United States. Meanwhile, in Japan, the problem may be caused by a quality control issue in which unnecessary substances were mixed into Kobayashi's production line.
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“Buyer beware”
Still, experts said Japan's scenario raises concerns for other markets, including the United States.
“I think this particular issue is likely to affect products outside of Japan as well,” said an independent study known for testing pharmaceutical impurities and detecting carcinogens in products such as acne cream. said David Wright, president and co-founder of Valisure. Sunscreen and heartburn medicine Xantec. He noted that the supply chain for health and nutritional supplements is similar to that for prescription drugs, with products being manufactured in one country and then shipped to many geographic markets. did.
According to Kobayashi's website, the company is working to expand sales of six brands, including over-the-counter drugs, in the United States, China, and Southeast Asia. The company's U.S. subsidiary, Kobayashi Healthcare in Dalton, Georgia, did not respond to a request for comment.
“There is a place for supplements, but it's a situation that buyers should be aware of,” said Todd Cooperman, Ph.D., president and founder of ConsumerLab.com, which tests supplements to determine content. Ta.
The Food and Drug Administration did not respond to requests for comment.
When properly produced, yeast grown in rice produces a variety of compounds, including lovastatin, which is known to lower cholesterol, the doctor said. “But if something goes wrong during production, you end up with citrinin, a chemical associated with kidney toxicity in animals, instead,” Cooperman said.
Many people purchase dietary supplements and herbal medicines online or over the counter, thinking they are regulated just like pharmaceuticals. However, the FDA does not verify the listed ingredients in supplements, and while federal law requires medicines to meet certain standards, the rules are less stringent for supplements.
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ConsumerLab.com last tested red yeast rice supplements in 2022 and found citrinin in 30% of the products tested, Cooperman said.
He noted that the United States had no limits on the chemical, adding that “some were 65 times higher than the limits set in Europe.”
Because lovastatin is classified as a drug, it is often excluded as an ingredient by supplement manufacturers seeking to avoid additional regulatory oversight.
When red yeast supplements became available in the United States more than 20 years ago, they offered a cheaper option than prescription statins available over the counter. However, it is difficult for consumers to check the ingredients of supplements or determine whether a product contains unlisted substances.
Consumers are “better off seeing a doctor and using prescription medications that lower cholesterol levels, because they are more likely to be effective,” Cooperman said. ”[S]Some older statins are now generic, so it's probably cheaper and safer to buy a generic statin at this time. ”
On the other hand, the government urges caution when taking supplements.
“There are a lot of brands out there that are more responsive,” Cooperman said. “We're focused on finding the best products. One in five products fail. I know that,” he said.
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