Ayurvedic medicines are used by a majority of India’s 1.1 billion population and worldwide by people from South Asia, as well as others, according to background information in the article. “However, since 1978 more than 80 cases of lead poisoning associated with Ayurvedic medicine use have been reported worldwide,” the authors write. Ayurvedic medicines are divided into two major types: herbal-only and rasa shastra, which is an ancient practice of deliberately combining herbs with metals (e.g., mercury, lead, iron, zinc), minerals (e.g., mica) and gems (e.g., pearl). Rasa shastra experts claim that these medicines, if properly prepared and administered, are safe and therapeutic. The prevalence of metals in Ayurvedic medicines sold via the Internet and in those manufactured in the United States is unknown.
Robert B. Saper, M.D., M.P.H., of Boston University School of Medicine and Boston Medical Center, and colleagues conducted a study to determine the prevalence of Ayurvedic medicines available via the Internet containing detectable lead, mercury, or arsenic and compared the prevalence of toxic metals between U.S.- and Indian-manufactured products, and in rasa shastra vs. non–rasa shastra medicines. The researchers conducted an Internet search using the search terms Ayurveda and Ayurvedic medicine and identified 673 products, of which 230 Ayurvedic medicines were randomly selected for purchase in August - October 2005. Country of manufacturer/Web site supplier, rasa shastra status, and claims of Good Manufacturing Practices were recorded. Metal concentrations were measured using x-ray fluorescence spectroscopy. One hundred ninety-three of the 230 requested medicines were received and analyzed.
The researchers found that the prevalence of metal-containing products was 20.7 percent and that the prevalence of metals in U.S.-manufactured products was 21.7 percent, compared with 19.5 percent in Indian products. Rasa shastra medicines were more than twice as likely as non–rasa shastra products to contain detectable metals and had higher median (midpoint) concentrations of lead and mercury. Among the metal-containing products, 95 percent were sold by U.S. Web sites and 75 percent claimed Good Manufacturing Practices. All metal-containing products exceeded 1 or more standards for acceptable daily metal intake. “Several Indian-manufactured rasa shastra medicines could result in lead and/or mercury ingestions 100 to 10,000 times greater than acceptable limits,” the authors write.
“A 2005 Institute of Medicine report concluded that ‘the regulatory mechanisms for monitoring the safety of dietary supplements … [should] be revised. The constraints imposed on FDA [U.S. Food and Drug Administration] with regard to ensuring the absence of unreasonable risk associated with the use of dietary supplements make it difficult for the health of the American public to be adequately protected,” the researchers write. “New FDA regulations and current Indian policies do not specify any maximum acceptable concentrations or daily dose limits for metals in dietary supplements for domestic use. We suggest strictly enforced, government-mandated daily dose limits for toxic metals in all dietary supplements and requirements that all manufacturers demonstrate compliance through independent third-party testing.”