Botanicals May Contain Acid That Causes Kidney Damage, Cancer

The Food and Drug Administration (FDA) issued a warning in mid-April for consumers to avoid using any products that contain or may contain aristolochic acid—an ingredient derived from the plant Aristolochia.

The agency issued the warning after it discovered the ingredient in 18 products being sold in the United States. The ingredient is typically used in traditional medicines and botanicals. The FDA investigation found aristolochic acid in the following products: BioSlim Doctor’s Natural Weight Loss System Slim Tone Formula, Clematis & Carthamus Formula 21280, Fang Ji Stephania, Green Kingdom Akebia Extract, Green Kingdom Stephania Extract, Mu Tong Clematis armandi, Neo Concept Aller Relief, Prostatin, Qualiherb Chinese Herbal Formulas Dianthus Formulas Ba Zheng San, Rheumixx, Stephania tetrandra, Temple of Heaven Chinese Herbs Radix aristolochiae, and Virginia Snake Root. The FDA has been trying to prevent the sales of these products in the United States by issuing an import alert that allows it to detain products that it suspects contain the dangerous acid.

In addition to its recent findings, the FDA has received two reports of kidney disease that have been linked to the use of botanicals containing the acid. The acid has also been linked to kidney disease and urinary tract cancer in Belgium, France, and the United Kingdom. In Belgium, 100 cases of renal failure and 18 cases of urothelial carcinoma in a group of people who took a weight-loss powder containing aristolochic acid. In the United Kingdom, aristolochic acid has been linked to two cases of interstitial fibrosis and end-stage renal failure. And in France, the acid has been linked to one case of urothelial cancer and two likely cases of the cancer.

The FDA is warning consumers not to use any botanical products that have not been tested in a laboratory for the presence of aristolochic acid. The FDA warns that the absence of the ingredient from a product’s label is not definitive proof of its absence from the product. The FDA does not oversee the labeling of botanicals, and the agency warns, aristolochic acid is frequently substituted for certain botanical ingredients that appear on product labels, such as Stephania tetrandra, Clematis armandii, and Alkebia extract. The FDA recommends that any consumer considering the use of a product that could possible contain the acid contain the manufacturer and ask about its testing protocol in determining whether the acid is present.

The agency is also warning consumers who are currently using or have used any botanicals or traditional medicines containing aristolochic acid to consult their health care providers. The FDA warns that while large amounts of aristolochic acid may cause a rapid onset of adverse events, low-dosage use over a prolonged period may cause irreversible damage without prior warning.

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