The U.S. Food and Drug Administration sent warning letters to seven companies and one nutritionist who sell chemicals called chelators to treat autism, cardiovascular diseases and other conditions, informing them they are violating federal law.
"These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options," said Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief." The FDA also cited several companies for selling heavy metal detection lab tests, stating they had not been approved by the agency, among other problems.
Despite a lack of scientific proof, alternative medicine practitioners have long touted chelation as a miraculous cure for a wide range of conditions, from Alzheimer's disease to Parkinson's disease. Most of the conditions are chronic, and most are incurable.
The letters come a year after a Chicago Tribune investigation found chelation treatment is popular among parents of children with autism, even though the therapy is dangerous and based on a disproven hypothesis that children with the disorder are actually suffering heavy metal poisoning.
Children undergo rounds of chelation therapy to leach heavy metals from the body, though most toxicologists say the test commonly used to measure the metals is meaningless and the treatment potentially harmful. Chelators are given by mouth, through IVs, in creams and by suppositories.
In 2008, the National Institutes of Health halted a controversial government-funded study of chelation before a single child with autism was treated. Researchers at Cornell University and University of California, Santa Cruz, had found that rats without lead poisoning showed signs of cognitive damage after being treated with a chelator.
In 2005, a 5-year-old with autism had a heart attack and died while being intravenously chelated in the office of a Pennsylvania physician, according to court records.
This round of warning letters were sent to World Health Products, Hormonal Health, Evenbetternow, Maxam Nutraceutics, Maxam Laboratories, Cardio Renew, Artery Health Institute, Longevity Plus and Rhonda Henry, a nutritionist based in Nevada.
On Wednesday morning, Evenbetternow was still selling Kids Chelat on its Web site ($46.50 a bottle), one of the nine products cited in the warning letter. One testimonial cited by the letter was also still on the Web site: "The Kids Chelat totally changed my autistic son from a hand flapping hyper kid to a sweet mellow angel."
According to the company Web site, Kids Chelat contains "sodium EDTA." It is unclear whether the product contains disodium EDTA or calcium disodium EDTA.
According to the FDA, the agency has received reports of 11 deaths associated with the use of disodium EDTA, including five since 2003. Five of the deaths resulted from confusing disodium EDTA with calcium disodium EDTA.
In June, the FDA sent a warning letter to a maker of a supplement aimed at children with autism called OSR#1, based on chelators originally developed to treat wastewater in mining operations.
The product was the subject of a Tribune investigation published in January.
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