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FDA Issues Warnings to Marketers of Unapproved 'Chelation' Products
Date:10/14/2010

tions," said Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief."

The agency advises consumers to avoid non-prescription products offered for chelation or detoxification. The only FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron overload. Procedures involving these agents carry significant risks and should be performed only under medical supervision.

The FDA has noted an increase in "chelation therapy" products marketed on the Internet that claim to cleanse the body of toxic chemicals and heavy metals. 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 transmucosal sprays, suppositories, capsules, liquid drops, and clay baths.

Some of the companies also sell unapproved screening tests that claim to detect the presence of heavy metals in urine to justify the need for chelation therapy.

"FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness," said Dara A. Corrigan, associate commissioner for Regulatory Affairs.

Under the FFDCA, companies that market products that claim to prevent, diagnose, treat or cure diseases must file an application with the FDA and provide data that demonstrate their products' safety and effectiveness.

The companies must take prompt action to correct the legal violations cited in the warnings letters or face possible legal action, including seizure and injunction. The FDA issued warning letters to the following companies:


SOURCE U.S. Food and Drug Administration
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