News Story
FDA warns makers of chelation treatments
By Julie Steenhuysen (Reuters)
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.