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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration is warning consumers not to purchase or to use Thorne Research’s Captomer or Captomer-250, marketed as a dietary supplement for heavy metal toxicity and heavy metal chelation therapy. The products list DMSA (meso-2, 3-dimercaptosuccinic acid), as an active ingredient, which is contained in an FDA-approved prescription product indicated for the treatment of lead poisoning in children.
FDA advises consumers to avoid all products offered over-the-counter (OTC) for chelation or detoxification. Procedures involving chelation agents carry significant risks and should be performed only under medical supervision.
There are no FDA-approved OTC chelation products. FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron overload.
Thorne Research has agreed to voluntarily recall the products. For recall information, contact Thorne Research.
For more information, please visit: Captomer
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