FDA: Chinese Herb Causes Kidney Failure, Cancer
Aristolochic acid is known to damage the kidneys and cause cancer, Gail Engels tells WebMD.
"We feel like there is very little to support the benefits and much to be concerned about," says Engels, communications director at the American Botanical Council, a nonprofit educational organization promoting the responsible use of medicinal plants.
"When this first came up again, a few months ago, a lot of companies automatically, voluntarily took their product off the market," she says, adding that some manufacturers and distributors have not pulled their products. "We just feel like there are a lot of issues right now about herbs; defending carcinogens right now just isn't something we want to do."
But there is a larger issue underlying the health problems associated with this one particular extract. Last year, in the same issue of the New England Journal of Medicine that contained a study on the Belgian patients, FDA Commissioner David Kessler, MD, blasted the controversial Dietary Supplement Health and Education Act of 1994 for allowing the supplement industry to escape regulation.
While the number of problems related to aristolochic acid has been on the rise throughout the 1990s, Kessler wrote, the FDA had -- up to that point -- failed to respond. Kessler made the point that, beyond the problems linked to this individual extract, the current system is badly in need of an overhaul, adding that dietary supplements (unlike drugs) don't have to be shown to be safe and effective before being allowed on the market.
In response, industry officials say that the majority of their products have been used safely for thousands of years. And probably not as diet drugs -- at least not in the Chinese tradition, which has not made a goal of losing weight, according to Adriane Fugh-Berman, MD, a consultant with federal agencies on herbs and dietary supplements.
And some question whether the FDA even exerts what regulatory authority it does have -- specifically, that of ensuring that dietary supplements are free from contaminants that might cause health problems.
"The FDA has the power to stop any company from selling a dietary supplement that is toxic or unsanitary; they can stop the sale of a dietary supplement that make false or unsubstantiated claims; they can take action against a dietary supplement that poses a significant, unreasonable risk of illness or injury; they can stop any company making a claim that a product cures or treats a disease; they can stop a new dietary ingredient from being marketed if they don't receive enough safety data in advance; and they can require a dietary supplement to meet strict manufacturing requirements, including potency, cleanliness and stability," says Engels. "To me that means they are regulated."
"Now, whether the FDA actually has the staff power to stay on top of every single herbal product that comes out, that is another question," she says.