FDA: Chinese Herb Causes Kidney Failure, Cancer

From the WebMD Archives

April 16, 2001 --The U.S. Food and Drug Administration has issued a warning for consumers to stop using dietary products that contain aristolochic acid, found primarily in a Chinese herb called Aristolochia fangchi. Consumption of products containing the botanical ingredient has been associated with permanent kidney damage; the product has also been linked to certain types of cancer, most often occurring in the urinary tract.

So far, the ingredient has been found in at least 16 products sold in the U.S., either as a single-ingredient product or as part of a supplement mixture. The products may list the ingredients "aristolochia," "bragantia," or "asarum" on the label.

Complicating the matter, aristolochia is sometimes substituted for other botanicals -- including Stephania tetrandra, Clemantis armandii, and akebia extract.

The products affected by the FDA alert include:

  • Rheumixx
  • BioSlim Doctor's Natural Weight Loss System Slim Tone Formula
  • Prostatin
  • Fang Ji Stephania
  • Mu Tong Clematis armandi
  • Temple of Heaven Chinese Herbs Radix aristolochiae
  • Meridian Circulation
  • Qualiherb Chinese Herbal Formulas Dianthus Formulas Ba Zheng San
  • Clematis and Carthamus Formula 21280
  • Virginia Snake Root Cut Aristolochiaserpentaria
  • Green Kingdom Akebia Extract
  • Green Kingdom Stephania Extract
  • Neo Concept Aller Relief
  • Mu Tong Clematis armandi
  • Fang Ji Stephania
  • Stephania tetrandra roots, whole

The FDA has issued warning labels and requests for recalls to the various manufacturers or distributors involved.

The trouble for aristolochic acid started after at least 100 individuals -- all clients of one diet clinic in Belgium -- developed end-stage kidney failure; additionally, a number of them were found to have some kind of kidney or bladder cancer. The Belgian Ministry of Health traced the problem to a prescription weight-loss capsule containing aristolochic acid (which had been accidentally added to the mixture in place of another herb).

Kidney failure began anywhere from three months to seven years after the patients had stopped taking the weight-loss capsules. Testing of 39 samples of kidney tissue showed that bits of genetic material from the herb had attached to the patients' chromosomes. Researchers think the material may turn on cancer genes or turn off genes that protect against cancer -- or both.

Similar cases have also been found in the United Kingdom and in France, prompting the FDA, in May 2000, to impose an import alert on products labeled "aristolochia" or believed to contain aristolochic acid, and to alert healthcare professionals in this country.

Recently, the FDA received reports of two patients in the U.S. who developed serious kidney disease associated with the use of products containing aristolochic acid. One patient had a kidney transplant, and the second is awaiting one. The FDA is asking healthcare professionals to report cases of kidney disease or cancers associated with the use of this product.

Some in the supplement industry are glad the FDA is sounding the warning on aristolochia.

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.