The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration (FDA) is reminding consumers to be wary of so-called “chelation” products that are marketed over-the-counter (OTC) to prevent or treat diseases such as lead poisoning. These products are not FDA approved.
Chelation involves the use of certain chemicals to remove heavy metals from the body. In medicine, chelation has been used for the treatment of metal poisoning, among other conditions.
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 ahealth care practitioner.
Illegal OTC chelation products are frequently marketed to deceive consumers into thinking they are taking a product that has been evaluated by FDA. Companies that make unapproved products often highlight that their product contains the same ingredient as an FDA-approved drug, suggesting that it is OK for them to market their drug without FDA approval. However, this is not permitted. Under FDA law and regulations, the company first must show that its product (whether or not it includes a previously-approved drug) is safe and effective before it may be marketed. The OTC chelation products have not been subject to the rigorous approval process and manufacturing scrutiny required for FDA-approved products, and are therefore not being legally marketed.
For more information please visit: Chelation