Ayurvedic medicine is a traditional system of healing arts that originated in India. It involves using products such as spices, herbs, vitamins, proteins, minerals, and metals (e.g., mercury, lead, iron, zinc). Some preparations combine herbs with minerals and metals. These products are commonly sold on the Internet or in stores and are represented as "Indian" or "South Asian."
"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).
The Food and Drug Administration (FDA) is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. FDA first alerted the public to the theft in June 2009.
Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. The agency has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial...
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.
Concerns About Heavy Metals
The presence of metals in some Ayurvedic products makes them potentially harmful. A study published in the August 27, 2008, issue of the Journal of the American Medical Association (JAMA), demonstrated that one-fifth of U.S.-manufactured and Indian-manufactured Ayurvedic products bought on the Internet contained detectable lead, mercury, or arsenic.
Researchers found 25 Web sites selling Ayurvedic products. After identifying 673 products, they randomly selected 230 for purchase. Of those, they received and analyzed 193 products. Nearly 21 percent were found to contain detectable levels of lead, mercury, or arsenic.
All metal-containing products exceeded one or more standards for acceptable daily metal intake. The researchers concluded that several Indian-manufactured products could result in lead and/or mercury ingestions 100 to 100,000 times greater than acceptable limits.
This study followed a previous study published in JAMA on December 15, 2004, which found that one out of five Ayurvedic "herbal medicine products" produced in South Asia and available in South Asian grocery stores in Boston contained potentially harmful levels of lead, mercury, and/or arsenic.