CHICAGO The U.S. Food and Drug Administration is cracking down on the over-the-counter sale of so-called chelation products that claim to treat conditions such as autism, heart disease and Alzheimer's by removing heavy metals from the body.
The FDA said on Thursday it sent warning letters to eight companies telling them their products were unapproved drugs and devices, and any claims about treating medical conditions with these products violated federal law.
"These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options," Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said in a statement.
"The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief," Autor said.
Although there are FDA-approved chelation drugs that are used in cases of heavy metal poisoning with a prescription, no chelation therapy products are approved for sale over the counter or on the Internet, the FDA said.
"What we're telling consumers today is that any chelation therapy marketed over the counter is suspect," Michael Levy, director of the FDA's Division of New Drugs and Labeling Compliance, told a telephone briefing.
Serious safety issues have been linked with chelation products, which can alter the levels of certain substances in the blood. Even when used under medical supervision, these products can cause serious harm, including dehydration, kidney failure and death.
One child died while being treated for autism with an intravenous chelation product, FDA officials told the briefing. And they said there are likely many cases of serious side effects because companies are not compelled to report adverse events to the agency.
Companies that got the warning letters claim that their products treat a range of diseases by removing toxic metals from the body, the agency said.
Some also claim to treat autism spectrum disorder, cardiovascular diseases, Parkinson's disease, Alzheimer's disease, macular degeneration -- a major cause of blindness -- and other serious conditions, the FDA said.
And some companies that got warning letters also make test kits and claim their products can detect heavy metals, thereby justifying the need for chelation therapy.
The FDA issued the warning because agency officials said there has been an increase in claims for and the availability of these products sold directly to consumers.
The FDA said companies need to act quickly to correct violations listed in the warning letters or face possible legal action, including seizure of their products.
The letters were issued to the following companies: World Health Products LLC; Hormonal Health LLC; Evenbetternow LLC; Maxam Nutraceutics/Maxam Laboratories; Cardio Renew Inc; Artery Health Institute LLC; Longevity Plus, and Dr. Rhonda Henry, a nutritionist.
(Editing by Vicki Allen)