Wednesday, July 29, 2015

Medscape: Did HHS Cancel Proposed FDA Limits on Mercury Fillings?

Medscape: Did HHS Cancel Proposed FDA Limits on Mercury Fillings?

  July 29, 2015
"In January 2012, the US Food and Drug Administration (FDA) appeared ready to prohibit the use of mercury-based dental fillings, or dental amalgam, in pregnant women, nursing mothers, children aged less than 6 years, and other groups considered sensitive to the metal's neurotoxic vapors.
The agency also was ready to advise dentists that "alternative materials would best be offered as the first line of restorative care minimizing the use of dental amalgam," according to a draft FDA safety communication dated "January XX, 2012."
The proposed FDA guidance, stemming more from cautious uncertainty than clear evidence on dental amalgam's effects on health, would have represented a sea change in the government's regulation of the controversial filling material.
However, as part of the US Department of Health & Human Services (HHS), the FDA needed a green light from higher-ups to issue this guidance. The green light never came.
"We were unable to obtain clearance from HHS," an FDA official told an attorney in February 2012 in a lawsuit seeking to either ban or limit the use of dental amalgam. "We are still working on securing that clearance. When or even if it will happen I cannot say."...

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