Doctors Issue New Warning on Cholesterol-Reducing Supplement After 5 Deaths

A close up of a person holding dietary supplement capsules in their hand — vorDa/iStock

Even though many people take supplements for their purported health benefits, those supplements are not without their own set of risks. Whether it's quality control issues or dangerous interactions with other things you're taking, it's always best to stay aware of any potential health hazards in your routine. Now, doctors are warning about a cholesterol-reducing supplement that could cause serious illness—and potentially be fatal.

On March 22, Japan-based Kobayashi Pharmaceutical Co. first announced a full recall of its products after discovering that dietary supplements containing benjikoji had sickened consumers, the Associated Press reported. As of March 29, 114 people had been hospitalized and five people had died after using products that contain the ingredient, with many reporting kidney problems.

Benjikoji is derived from a red mold made by fermenting rice and is sold with purported abilities to help lower cholesterol, CBS News reports. The company said it had discovered a toxic chemical compound known as puberulic acid in the recalled products, which may have resulted from quality control issues during production.

While some Kobayashi products were exported internationally, no recalls have been initiated for benjikoji supplements within the U.S. But now, some doctors are warning that the issue will likely not be an isolated incident.

"I believe it is likely that this particular problem affects products outside Japan as well," David Light, president and co-founder of drug safety and impurity watchdog company Valisure, told CBS News.

The U.S. Food & Drug Administration (FDA) regulates dietary supplements differently than medicines and prescription drugs. According to the agency's website, this means that supplement companies "are responsible for evaluating the safety and labeling of their products" before they're released to the market and that the FDA does not have the authority to approve or deny them before they go on sale to the public.

Production issues can be particularly problematic with red yeast products. According to a test conducted in 2022 by ConsumerLab.com—which independently tests supplements for impurities and potency issues—nearly a third of all benjikoji-based products sampled contained citrinin, CBS News reports. The chemical is a potential byproduct during the production of red yeast and can cause kidney toxicity.

"One had 65 times the limit set in Europe," Tod Cooperman, MD, president and founder of ConsumerLab.com, told CBS News.

Even when they're not dangerous, many benjikoji products may simply be ineffective. A study from ConsumerLab.com also found that only two supplements out of 10 tested contained a sufficient amount of lovastatin, the compound known to help lower cholesterol.

For those who are concerned about their health, Cooperman says it's likely easier to tackle cholesterol issues by getting a prescription for an approved medicine from your doctor. "Some of the older statins are generic now, so it's probably less expensive and safer to be buying a generic statin at this point," he told CBS News.

Zachary Mack Zach is a freelance writer specializing in beer, wine, food, spirits, and travel. He is based in Manhattan.Read moreFiled UnderHealth Advice • News • SafetySources referenced in this article