FDA announces inquiry into chelation supplements

The Food and Drug Administration put eight companies on notice that their over-the-counter (OTC) chelation products are unapproved drugs and devices, and that it is a violation of federal law to make unproven claims about these products. The targeted supplements contain EDTA.

According to the FDA, the targeted companies claim their products treat a range of diseases by removing toxic metals from the body, including autism, cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease, and macular degeneration. The agency said there are serious safety issues associated with chelation products, which can alter the levels of certain substances in the blood. 

In its October 14 press conference, the FDA implied that chelation products were being used by parents of children with autism without a doctor's supervision. But on questioning by reporters, FDA representatives were unable to back up the claim with any evidence of use of OTC chelation products by autism parents or of their use without medical supervision. The FDA asserted that the OTC products being promoted were dangerous. On questioning by reporters, the FDA admitted that it had received no reports of adverse reactions to the products or to chelation in general, other than 1 death 5 years ago which was due to a medical error and in which a prescription drug was used. The FDA suggested that the reason it had received no reports on side effects was because parents and patients were unable to make the connection between the product and any harmful effects, yet they had no documentation to support this claim. The FDA also admitted that its action was prompted by "the prominence of the products on the internet" and was not due to any safety issues. “Just because we don’t have evidence of lots of adverse events doesn’t mean there’s no risk from these products,” said Charles Lee, medical officer at the FDA’s Center for Drug Evaluation and Research.

The eight companies are World Health Products, Hormonal Health, World Health Products, Evenbetternow, Maxam Nutraceutics/Maxam Laboratories, Cardio Renew, Artery Health Institute, Longevity Plus, and Dr. Rhonda Henry.

SafeMinds, an autism organization, said it feels that FDA is trying to cast autism parents in a negative light by implying parents were giving their children dangerous products. “Only on questioning by the media did the FDA have to back off from its wild claims. SafeMinds feels the FDA owes the autism community an apology.”

Dr. Grout’s comment

The FDA acted in the complete absence of consumer complaints, and has acted without substantiating any negative results. This is reminiscent of last year’s heavy handed action against desiccated thyroid, a natural remedy used safely for decades before the pharmaceutical version, Synthyroid, came on the market. This is going to raise questions of whether the FDA, long accused of having a too-cozy relationship with the drug companies, is really trying to protect the revenue streams for statins, stents, and by-pass surgeries – and whether it is trying to dampen claims that mercury in vaccines contributed to developmental disabilities. This is going to raise questions of whether the FDA is being used by special interests to again attack natural medicine. In Arizona, for example, it is already considered “unprofessional behavior” for an M.D. – a cardiologist – to use chelation to treat heart disease. Although I am an M.D., I can use chelation because I also have the homeopathic physician’s license.  

Chelation therapy is used in the treatment of chronic illness because heavy metals are inflammatory and neurotoxic. Inflammation is the underlying cause of much chronic disease. Despite what the FDA asserts in this notice, it is well established that by decreasing the total body load of toxins, the body is more easily able to heal from its injuries and become healthy again. This is true for autism, heart disease, and other chronic diseases.

EDTA is an excellent chelating agent, meaning it removes heavy metal contaminants. That is well established. City water systems put it in as a pre-treatment item. Chlorella is used in water treatment facilities to chelate heavy metals as well. You find EDTA listed as an ingredient in many food products because it is an antioxidant – keeps food from spoiling.

Some OTC chelation products use things which are not yet proven (clay foot baths, for instance), but there is no evidence that they do any harm. Other OTC products use homeopathic remedies which operate on the energetic level which we are not yet able to measure. There is no evidence that they do any harm either.

There is a valid question here, however, of whether chelation should be done outside the oversight of a physician’s care. When chelating agents are given either intravenously or orally, I fall into the camp of agreeing that the chelation should be done under medical supervision – whether this be allopathic MD or DO, homeopathic MD(H) or DO(H), chiropractor with internal medicine certification, naturopathic physician, nurse practitioner – anyone who is licensed to practice medicine can become qualified to treat heavy metal toxicity. OTC products place a substantial burden of responsibility on the consumer. That said, I have not heard of anyone dying because of it. Some electrolyte imbalances can occur and need to be monitored for electrolyte replacement during the course of the oral therapy. It’s easy enough to do.

The FDA and the AMA have had a problem with chelation therapy for many years. Often chelation therapy will reduce the symptoms of patients with chest pain to the point where they do not need a cardiac bypass graft or antihypertensive medications… But since the only evidence that we have are the patient’s reported symptoms, these are considered to be “subjective.” The diameter of a coronary artery is so small that it is difficult, if not impossible, to measure small changes in diameter. Since blood flow through an artery is proportional to the 4^th power of the radius (i.e. 2x2x2x2) – even a tiny increase in the diameter of the blood vessel (diameter = twice the radius) can result in significantly larger flow, whether we can measure the diameter change or not. Increasingly, the literature points to inflammation and infections as the underlying causes of heart disease and chelation therapy reduces inflammation and infections.

In 2003, the National Institutes of Health launched the first large scale study of chelation for patients with coronary artery disease. Hundreds of medical clinics across the country are participating in this five year, placebo-controlled, double-blind study. We are not. This study was long resisted by the holistic community because many view double-blind studies as unethical; they require withholding treatments from participants who receive just a placebo. 

As of this writing, the study has completed enrollment of patients. Participants will continue to be followed through 2011, and the results will be analyzed in 2012.

Want to see the petition circulating about this? Go to the Alliance of Natural Health at www.anh-usa.org/tell-fda-hands-off-chelation.