Recall of red yeast products linked to at least five dead in Japan Americans might question the safety of a line of dietary supplements containing this ingredient that are readily available online and in stores.
Touted as a natural way to lower cholesterol, the products recalled by Kobayashi Pharmaceutical Co. contain benikoji, an ingredient derived from a species of mold.
At a news conference Friday, the company said it had found a chemical compound — puberulic acid — in the recalled products, and was investigating whether the substance could be linked to the deaths, the Japan Times newspaper reported. Kobayashi also said its products were exported to other countries, including China and Taiwan.
As of yet, no products containing benikoji have been recalled in the United States or linked to health concerns. In Japan, the problem may have stemmed from a quality control issue that allowed unwanted substances to enter Kobayashi’s production line.
“Buyer beware”
Nonetheless, the scenario in Japan raises concerns for other markets, including the United States, according to experts.
“I think it’s likely that this particular problem also affects products outside of Japan,” said David Light, president and co-founder of Valisure, an independent laboratory that tests for drug impurities and is known for detecting substances carcinogens in products such as acne creams. sunscreen and heartburn medicine Zantec. He noted that supply chains for dietary and health supplements are similar to those for prescription drugs, with products manufactured in a single country then shipped to many geographic markets.
According to Kobayashi’s website, the company is working to increase sales of six brands, including over-the-counter pharmaceuticals, in the United States, China and Southeast Asia. Its U.S. subsidiary, Kobayashi Healthcare in Dalton, Georgia, did not immediately respond to requests for comment.
“There is a place for supplements, but it’s a buyer beware situation,” said Dr. Tod Cooperman, president and founder of ConsumerLab.com, which tests supplements to determine their contents.
The Food and Drug Administration did not immediately respond to requests for comment.
When prepared correctly, yeast grown on rice produces various compounds, including lovastatin, known to lower cholesterol, the doctor explained. “But if something goes wrong in production, you get citrinin instead,” a chemical linked to kidney toxicity in animals, Cooperman said.
Many people purchase dietary supplements and herbal medications online or over the counter, assuming they are regulated like medications. But the FDA doesn’t verify the ingredients listed in supplements, and although federal law requires pharmaceutical products to meet specific standards, the rules are less strict when it comes to supplements.
ConsumerLab.com last tested red yeast rice supplements in 2022, finding citrinin in 30% of the products tested, Cooperman said.
“The limit set in Europe was 65 times higher,” he added, noting that the United States has not set a limit for the chemical.
Because lovastatin is classified as a drug, it is often left out as an ingredient by supplement manufacturers looking to avoid additional regulatory review.
When red yeast supplements became available in the United States more than two decades ago, they offered a less expensive option than prescription statins available over the counter. But it’s difficult for consumers to check a supplement’s ingredients or determine if a product contains unlisted substances.
Consumers would be “better off going to the doctor and using a low-cholesterol prescription drug because they have more certainty about what they’re getting,” Cooperman said. “(Some) of the older statins are now generic, so it’s probably cheaper and safer to buy a generic statin at this point.”
In the meantime, he urges caution when taking supplements.
“There are a lot of brands that are more discreet,” Cooperman said. “Our goal is to try to find the best products. We find that one in five products fail.”
Grub5
