    |
By NCCAM, National Center for Complementary and Alternative Medicine and FDA Consumer Health Information / U.S. Food and Drug Administration
Ayurveda is a traditional medical system that originated in India. It aims to integrate and balance the body, mind, and spirit to help prevent illness and promote wellness. Potentially toxic metals sometimes are incorporated in traditional Ayurvedic medicines as part of rasa shastra—a practice which combines herbs with metals, minerals, and gems. While rasa shastra practitioners claim that such medicines are safe if properly prepared, concerns regarding safety from metal intoxication remain. In an NCCAM-funded study, researchers sought to determine how often Ayurvedic medicines sold on the Internet contain detectable levels of lead, mercury, and arsenic. They purchased products manufactured in both India and the United States and examined both rasa shastra and non-rasa shastra (herbal-only) medicines.
Using five different search engines, the researchers found 25 Web sites that sold traditional Ayurvedic herbs, formulas, and ingredients. They identified 673 products and randomly selected 230 for purchase in August–October 2005; 193 of these products were received and tested for the presence of metals.
Nearly 21 percent of the Ayurvedic medicines tested were found to contain detectable levels of lead (most common), mercury, or arsenic. All metal-containing products exceeded one or more standards for acceptable daily metal intake. The prevalence of metal-containing products did not differ significantly by country of manufacture. Rasa shastra products were more than twice as likely as non-rasa shastra products to contain metals, and several rasa shastra medicines manufactured in India could result in lead and/or mercury ingestion 100 to 10,000 times greater than acceptable limits. Although manufacturers of 75 percent of the toxic metal-containing products claimed they used Good Manufacturing Practices or metal testing, such claims were not associated with a lower prevalence of toxic metals. The investigators did note that products from members of the U.S.-based American Herbal Products Association had a lower prevalence of toxic metals.
The researchers suggest conducting observational studies to assess the lead burden and consequences resulting from use of these medications. They also suggest the creation of strictly enforced, Government-mandated, daily-dose limits for toxic metals in all dietary supplements, and requirements that all manufacturers demonstrate compliance through third-party testing. The findings also lend support to the value and importance of rigorous standards of product quality and self-regulation within the herbal medicine and dietary supplement industry.
FDA: Use Caution With Ayurvedic Products
Consumers should know that Ayurvedic products are generally not reviewed or approved by the Food and Drug Administration (FDA)," says Mike Levy, Director of the Division of New Drugs and Labeling Compliance in the Office of Compliance, part of FDA's Center for Drug Evaluation and Research (CDER).
Most Ayurvedic products are marketed either for drug uses not approved by FDA or as dietary supplements. As such, consumers should understand that these products have not been approved by FDA before marketing.
"The bottom line," Levy says, "is that consumers need to be on guard when purchasing any product using the Internet, especially medical products." This is an area that is challenging to regulate.
A Priority for FDA
"This issue has been and will continue to be a priority for FDA," Levy says. The agency has had an import alert on certain Ayurvedic products in place since 2007. This import alert allows FDA personnel to prevent these products from entering the United States.
"Through this import alert, the agency is able to stop commercial import shipments of these products," Levy says, "but individual Internet purchases are harder to monitor."
In light of recent reports, FDA is re-evaluating its existing import alert and considering possible enforcement actions related to Ayurvedic products manufactured in the United States.
Advice for Consumers
- Be aware that Ayurvedic products do not undergo FDA review. In accordance with current law, FDA does not evaluate these products before they are marketed. This means their safety, quality, and effectiveness cannot be assured by FDA. Certain populations, including children, are particularly at risk for the toxic effects of heavy metals.
- Use caution when buying medical products on the Internet. FDA urges consumers to beware of unregulated Internet drug sellers. Many of their products could pose direct or serious indirect health issues, or could contain toxic substances.
- Tell your health care professional about all alternative products. Some herbs, minerals, and metals can interact with each other and with conventional medications.
<html> <head> <meta http-equiv="Content-Type" content="text/html; charset=iso-8859-1" /> <title>Above Article Ads</title> </head> <body> <!-- 2 This is the HTML section of the badge --> <script type="text/javascript"><!-- google_ad_client = "pub-1717216010164069"; /* 728x90, created 5/4/09 */ google_ad_slot = "5710371685"; google_ad_width = 728; google_ad_height = 90; //--> </script> <script type="text/javascript" src="http://pagead2.googlesyndication.com/pagead/show_ads.js"> </script>
Reference
Saper RB, Phillips RS, Sehgal A, et al. Lead, mercury, and arsenic in U.S. and Indian-manufactured Ayurvedic medicines sold via the Internet. Journal of the American Medical Association. 2008;300(8):915–923.
Additional Resource
* More information from NCCAM on Ayurvedic medicine is available here: nccam.nih.gov/health/ayurveda/.
This page created 03 Dec 2010 18:36
Last updated 16 Apr 2012 04:47
| Share Site | Follow Us! | ||
   |
