The FDA has warned eight companies that their over-the-counter (OTC) chelation products are unapproved drugs and devices. These companies have made claims that their products treat autism spectrum disorder, cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease, macular degeneration, and other serious conditions by removing toxic metals from the body. 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 FDA is advising consumers to avoid OTC chelation products that are marketed to prevent or treat diseases. Although some of the products are marketed as dietary supplements, they are unapproved drugs because they claim to treat, mitigate, prevent, or diagnose disease. All FDA-approved chelation products require a prescription; the FDA has never approved any chelation product for OTC use for any health condition. 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 (eg, dehydration, kidney failure, and death).

Patients using OTC chelation products are advised to contact their healthcare provider if they experience any adverse effects related to the use of these products.

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