The Food and Drug Administration is encouraging health care professionals to report any adverse events associated with over-the-counter products marketed to patients as chelation treatments for various diseases. These products have not been approved by the FDA for any indication and are potentially dangerous.
During an Oct. 14 briefing, FDA officials said that warning letters had been sent to eight manufacturers of these products, saying that they are considered unapproved drugs and devices and that making unproven claims about the products violates federal law. If the companies don’t comply, they may be subjected to further legal action, including seizure of the products.
The FDA has not received any formal reports of severe adverse events associated with these products. Dr. Charles Lee, a medical officer in the division of new drugs and labeling compliance in the FDA’s Center for Drug Evaluation and Research, said that the risks of these products include dehydration, kidney failure, and death.
The companies have made claims that their products treat a variety of diseases by removing toxic chemicals and heavy metals from the body. Some of the companies also make tests that they claim can detect the presence of heavy metals to determine if chelation therapy is needed, the agency said.
Despite these claims, “the effectiveness in treating any of the diseases listed is unsubstantiated,” the statement said. The products— which are widely available on the Internet and come in transmucosal sprays, suppositories, capsules, liquid drops, clay baths, and other formulations— are marketed to treat the following conditions, including: cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease, macular degeneration, and autism spectrum disorder.
FDA-approved chelation therapies are approved only as prescription products; screening tests are considered devices and also require FDA approval.
The products covered in the warning letter include “Advanced Formula EDTA Oral Chelation,” which the manufacturer claims can unclog arteries, dissolve plaque, lower cholesterol, and prevent heart attacks. Another company promoted patient claims that its Kelatox suppository had almost completely eliminated peripheral neuropathy symptoms. One company’s clay baths are touted for their ability to remove chemical toxins that include food additives, cigarette toxins, and pesticides, and for producing “dramatic” improvements in children with autism.
Adverse events associated with these products should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch/.