FDA Targets Chelation Products

WASHINGTONFDA issued warning letters to eight companies on Oct. 14, noting certain products they are selling for chelation are unapproved drugs and devices, marketed in violation of federal law. The agency also released a consumer advisory, updating its Consumer Update website with details about the warning letters and urging consumers to avoid non-prescription products for chelation or detoxification.

In its warning letters, FDA noted the various products claim to treat a range of diseasesincluding serious conditions such as autism, Alzheimers disease and cardiovascular diseasesby removing toxic metals from the body. However, there are no approved over-the-counter chelation products; the use of such products can pose serious safety issues including dehydration and kidney failure.

These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options," said Deborah Autor, director of the Office of Compliance in the FDAs 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 stated it has seen 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.

Warning letters were issued to the following companies: Artery Health Institute LLC, Cardio Renew Inc., Dr. Rhonda Henry, Evenbetternow LLC, Hormonal Health LLC, Longevity Plus, Maxam Nutraceutics/Maxam Laboratories and World Health Products LLC. The companies must promptly correct the legal violations cited in the warning letters, or face possible legal action, including seizure and injuction. Dara A. Corrigan, associate commissioner for regulatory affairs, stated: FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness."