A series of fatalities in Japan have triggered a recall of red yeast products linked to at least five deaths in the country, sparking concerns about the safety of dietary supplements containing the ingredient. The recalled products, manufactured by Kobayashi Pharmaceutical Co., contain benikoji, a substance derived from a species of mold, with the company identifying a chemical compound known as puberulic acid in the products. Investigation is ongoing to determine if this substance played a role in the reported fatalities. Additionally, the company disclosed that its products were exported to other countries, including China and Taiwan, raising concerns about the global reach of the issue.
While there have been no product recalls or reported health issues related to benikoji-containing products in the United States, the situation in Japan has raised red flags about the quality control procedures in place at Kobayashi Pharmaceutical Co. Experts suggest that similar issues may affect products in other markets, including the U.S., as supply chains for health and dietary supplements often span multiple countries. This raises concerns about the regulation and oversight of dietary supplements, given that the FDA does not verify the ingredients listed on supplement labels.
Dr. David Light, president of Valisure, a lab that tests for impurities in drugs, emphasized the importance of consumer awareness in this “buyer beware” situation. He highlighted the similarities in supply chains between health supplements and prescription drugs, underscoring the need for increased vigilance when it comes to the quality and safety of dietary supplements.
ConsumerLab.com, another organization that tests supplements, found citrinin in 30% of red yeast rice products tested in 2022, with excessively high levels of the compound detected in some products. Dr. Tod Cooperman, president and founder of ConsumerLab.com, warned consumers about the lack of regulatory oversight for supplements, urging caution in the consumption of these products.
The availability of red yeast supplements as a cheaper alternative to prescription statins has made them popular among consumers, despite the challenges in verifying the ingredients and potential risks associated with unlisted substances. Cooperman advised consumers to consult with healthcare professionals and opt for prescription cholesterol-lowering medications for greater certainty and safety. Ultimately, the issue highlights the importance of transparency and regulation in the supplement industry to ensure consumer safety and well-being.