FDA issues warning on Ayurvedic medicines: some potentially harmful

ROCKVILLE, Md. The Food and Drug Administration on Thursday warned consumers to use caution when deciding to use Ayurvedic medicines. Ayurvedic medicine is a traditional system of healing arts that originated in India that involves using products such as spices, herbs, vitamins, proteins, minerals and metals.

According to FDA, some preparations combine herbs with minerals and metals and are commonly sold on the Internet or in stores represented as Indian or South Asian alternatives.

“Consumers should know that Ayurvedic products are generally not reviewed or approved by the Food and Drug Administration,”  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, said. “Consumers need to be on guard when purchasing any product using the Internet, especially medical products.”

The presence of metals in some Ayurvedic products makes them potentially harmful, the FDA noted. A study published in the Aug. 27 issue of the Journal of the American Medical Association 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, the agency reported.

“This issue has been and will continue to be a priority for FDA,” Levy said. 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.