ISSUE: FDA 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. There are no FDA-approved OTC chelation products.
Procedures involving chelation agents carry significant risks and should be performed only under medical supervision.
The company has received several adverse event reports associated with these products. Thorne Research has agreed to voluntarily recall the products. For recall information, contact Thorne Research.
BACKGROUND: FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron overload.
RECOMMENDATION: Do not purchase or use Captomer or Captomer-250. Avoid all products offered over-the-counter (OTC) for chelation or detoxification.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[06/13/2014 - Warning - FDA]