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FDA Drug Safety Podcast: FDA issues warnings to marketers of unapproved ‘chelation’ products

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On October 14, the FDA warned eight companies that their over-the-counter or O-T-C chelation products are unapproved drugs and devices. There are no FDA-approved O-T-C chelation products.

I am Yolanda Fultz-Morris from F-D-A’s Center for Drug Evaluation and Research.

Chelation therapy is used for the treatment of metal poisoning, among other conditions. FDA says consumers should avoid non-prescription products offered for chelation or detoxification. FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as the treatment of lead poisoning and iron overload. The agency says even the prescription medications carry significant risks, and they should only be used with medical supervision.

The companies that received warning letters claim that their products treat a range of diseases by removing toxic metals from the body. In addition, some of these companies claim their products will detect the presence of heavy metals to justify the need for chelation therapy. It is a violation of federal law to make unproven health claims.

Although some of the products are marketed as dietary supplements, they are unapproved drugs because they claim to treat, mitigate, prevent, or diagnose disease. The products come in various dosage forms, including mouth sprays, suppositories, capsules, liquid drops, and clay baths.

For a complete list of the companies that have been sent warning letters, consumers can go to:

W-W-W dot F-D-A dot GOV slash N-E-W-S-E-V-E-N-T-S, click on NEWSROOM, then click PRESS ANNOUNCEMENTS.

We urge healthcare providers and patients to report any side effects from chelation products by using the FDA’s MedWatch Adverse Event Reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot GOV slash M-E-D-W-A-T-C-H.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash D-R-U-G-S.


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