SILVER SPRING, Md., Oct. 14 /PRNewswire-USNewswire/ — The U.S.
Food and Drug Administration today warned eight companies that
their over-the-counter (OTC) chelation products are unapproved
drugs and devices and that it is a violation of federal law to make
unproven claims about these products. There are no FDA-approved OTC
chelation products.
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The companies that received the warning letters claim that their
products treat a range of diseases by removing toxic metals from
the body. Some also claim to treat autism spectrum disorder,
cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease,
macular degeneration, and other serious conditions. Some companies
that received the warning letters also claim their products will
detect the presence of heavy metals to justify the need for
chelation therapy.
The drug products involved have not been evaluated by the FDA
for treatment of these diseases, and violate the Federal Food,
Drug, and Cosmetic Act (FFDCA). Despite the claims of the companies
that received warning letters, the effectiveness in treating any of
the diseases listed is unsubstantiated. Depending on the condition,
when relying on unproven OTC chelation products to treat serious
conditions, patients may delay seeking effective medical care.
In addition, there are serious safety issues associated 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.
“These products are dangerously misleading because they are
targeted to patients with serious conditions and limited treatment
op
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