ISSUE: FDA advised consumers to avoid “chelation” products that are marketed over-the-counter (OTC) to prevent or treat diseases. There are serious safety issues associated with chelation products. Depending on the condition, when relying on unproven OTC chelation products to treat serious conditions, patients may delay seeking effective medical care. Even when used under medical supervision, these products can cause serious harm, including dehydration, kidney failure, and death.
BACKGROUND: Chelation involves the use of certain chemicals to remove heavy metals from the body. Although some of the products are marketed as dietary supplements, they are unapproved drugs because they claim to treat, mitigate, prevent, or diagnose disease. FDA has never approved any chelation product for OTC use for any health condition. All FDA-approved chelation products require a prescription because they can only be used safely under the supervision of healthcare practitioner.
RECOMMENDATION: The agency advises consumers to avoid non-prescription products offered for chelation or detoxification.
[10/14/2010 - Press Release  - FDA]
[10/14/2010 - Questions and Answers  - FDA]
[10/14/2010 - Consumer Update  - FDA]