FDA Consumer Warning: Dangerous Chelation Products to Treat Serious Diseases

On Oct. 14, 2010, the Food and Drug Administration (FDA) issued a warning urging people not to use dangerous, unapproved chelation products that are illegally promoted and sold — often as over-the-counter dietary supplements — for serious and sometimes incurable diseases.

The FDA stated that the companies promoting these products have not proved chelation treatments to be safe or effective in treating or preventing cardiovascular disease, diabetes, autism, macular degeneration, Parkinson’s disease, Alzheimer’s disease or any of the other serious illnesses for which the companies claim the products are effective. Some of the companies also claim, in an attempt to justify the need for chelation therapy, that their products can detect the presence of heavy metals in the body.

FDA-approved chelation therapy products have been shown to be effective only for specific indications, such as for the treatment of lead poisoning and iron overload, because they can bind these heavy metals and facilitate their removal from the body. The products require a prescription because they have significant risks and can be used safely only under the supervision of a health care practitioner.

There are two major safety concerns with these unproven products: First, consumers may delay seeking essential medical care to treat serious conditions such as heart and blood vessel disease. Second, chelation can result in dehydration, kidney failure and death.

The FDA’s consumer warning about over-the-counter chelation products coincided with the agency’s release of warning letters to eight companies illegally selling these products, stating that the companies were violating federal law by making unproven therapeutic claims about the products (see Table 1). We agree with the FDA’s statement that by promoting the unproven and dangerous products, the companies are preying on the sick and vulnerable.

What You Can Do

You should avoid chelation products sold as over-the-counter drugs or dietary supplements. The products come in a number of forms, including sprays, suppositories, capsules, liquid drops and clay baths.

Consumers may report serious adverse events with these products to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail, fax or phone.

• Online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
• Regular mail: Use postage-paid, pre-addressed FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088

Table 1. Companies That Received FDA Warning Letters for Illegally Promoting the Listed Chelation Products