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Medical News and Perspectives
November 17, 2010

FDA Warning Targets OTC Chelation Products

JAMA. 2010;304(19):2112. doi:10.1001/jama.2010.1654

The US Food and Drug Administration (FDA) has warned several companies that promoting their over-the-counter chelation products as treatments for autism, cardiovascular disease, and other serious health problems is dangerous and illegal.

“Although some of these products are marketed as dietary supplements, they are in fact unapproved drugs,” said Michael Levy, director of the FDA's Division of New Drugs and Labeling Compliance. Some of the 8 companies that received warning letters from the FDA in late October also market unapproved screening tests that claim to detect the presence of heavy metals in urine. The screening tests “falsely justify the need for chelation therapy,” Levy noted.

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