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."...