FDA clamps down on chelation products

FDA clamps down on chelation products

The U.S. Food and Drug Administration (FDA) warned eight firms selling chelation products that claim to treat medical conditions like Alzheimer’s, heart disease and autism by getting rid of heavy metals from the body.

The agency said the over-the-counter products were not approved and that their therapeutic claims violated federal regulations.

“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 at the FDA’s Center for Drug Evaluation and Research.

Certain chelation drugs are approved for use by the FDA but only with prescription to treat heavy metal poisoning. No chelation therapy medication should be sold via the Internet or over the counter, according to the FDA.

Michael Levy, director of the agency’s Division of New Drugs and Labeling Compliance said that, “What we’re telling consumers today is that any chelation therapy marketed over the counter is suspect.”

Chelation drugs change the chemistry of blood and other substances in the body and are very risky to use even under medical supervision. Cases of complications such as kidney damage, dehydration and death have been reported.

The FDA said that at least one autistic child died after being treated with chelation therapy, and many cases of adverse reactions to chelation remain unreported because the companies are currently not required to do so.

The chelation products in question have labels claiming to treat heart disease, autism, Parkinson’s, Alzheimer’s, macular degeneration and other serious diseases.

The FDA warned the companies that failure to rectify the violations would result to legal action.

Posted by George Daniels on Friday October 15 2010, 10:24 AM EST. All trademarks acknowledged. Filed under Featured News, Health. Comments and Trackbacks closed. Follow responses: RSS 2.0