DOCUMENTED CASES OF TOXICITY FROM NATURAL PRODUCTS

It is widely held that many dietary supplements such as herbal products are safe because they are advertized as natural. This perception that herbal remedies are inherently safe is also based on tradition. It is estimated that 80% of the worlds population uses herbal substances medicinally. Despite this, with the growing demand for these products there is a growing body of evidense of cases of toxicity. Botanicals are crude drugs and there are bound to be adverse effects as they contain complex mixtures of chemicals. In addition to their own toxic potentials, botanical products are associated with other factors that effect their safety.

Adulteration

A man was admitted to a cardiac intensive care unit in 2002 in complete heart block, a potentially lethal irregular heart rythum. The ginko babola he began taking 6 weeks prior contained digatalis, a powerful heart drug. This drug was either present in the raw materials prior to the manufacturer encapsulating it and they either did not do lab analysis of the raw materials or sent it out to a poor or worse bogus lab, or the manufacturer had sloppy encapsulating practices and cross contaminaton of multiple substances being prepared at the same time caused this serious event. There is no regulaton in place to date that would prevent this from happening again.

The Japanese Ministry of Health, Labor and Welfare reported that the use of certain imported Chinese dietary supplements was associated with liver failure and/or high thyroid function which has a potential for heart damage. These products proved to be adulterated with drugs and 622 pateints became ill, with 148 requiring hospitalization. There were three deaths.The offending products were recalled and the Ministry now requires manufacturers to chemically analyze all imported dietary supplements and herbs at certified laboratories. This is not routinely done step for step in the US.

Contamination

A patient of mine began taking milk thistle in tincture form 4 or 5 years ago as it had just been published that milk thistle may improve liver function and this fellow had chronic active hepatitis C. After a few months this patient developed an anemia and a tremor. The milk thistle tincture, purchased at a discount store, was analyzed by an independent chemistry lab at a major university and found to contain high levels of lead. Mineral supplements have been notorious for contamination with lead and publicity around this issue has forced some clean up of the problem.

ComsumerLab, on the web at www.consumerlab.com, skillfully fulfills their mission to identify the best quality health and nutrition products through independent testing. They reported duriing 2004 into 2005, no lead in any of the calcium products they checked. During that time they were still finding lead in potassium, magnesium and zinc products. Summer of 2005 they reported finding lead (2.3 mcg per recommended daily serving) in a calcium/magnesium combination product called Balanced Cal-Mag being sold by a very prominant physician's nutritional supplement company.

Lead is just one example of a toxic contaminant. Dioxins, PCB's and other chemicals amd minerals cause contamination.

Lack of Regulation

A particularly dramatic example of the toxicity of herbal products is the kidney failure and subsequent kidney cancer caused by Aristolochia fangchi, used for centuries in Europe and China as an herbal remedy. The chemical toxicity of A. fangchi was recognized when this herb was substituted for another in a weight loss preparation used in a Belgian health spa. Of the 105 who developed kidney disease after taking this preparation and were treated at one medical center, 39 with end stage kidney failure decided to have their kidney removed because of concerns about developing kidney cancer. Actual cancers were found in 18 of these patients and a precancerous condition (urothelial dysplasia) was found in 19 others. This syndrome called aristolochic acid nephropathy was also found in people of other countries including the US. Responsible manufacturers removed this from their products, but 19 products containing aristolochic acid and 95 products suspected to contain it can be purchased over the Internet today. The FDA has no ruling over this by law.

Lack of Adverse Event Reporting

There is no requirement for manufacturers of dietary supplements to record, investigate or report incidents of potential adverse effects to their products. This refers to the adverse reactions that produce immediate symptoms. It is estimated that 1% of adverse events caused by dietary supplements, including herbs, are reported to the FDA and only a fraction of these are adequately investigated. Forget about the reporting of long term toxicities also producing the likes of kidney or liver failure and cancers.