FDA Safety Communication: Reducing Exposure to Mercury Vapor Released From Dental Amalgam (Draft Jan 2012)

FDA Amalgam Safety Proposal

In January 2012, the FDA prepared a “Safety Communication” that recommended reducing the use of mercury amalgam in the general population, and avoiding it in susceptible subpopulations:

• pregnant and nursing women
• children under six years of age
• people with allergy to mercury or other components
• people with neurological disease
• people with renal disease

It also recognized the risk of occupational exposure for dental personnel.

The recommendations were never made public, and in January 2015, the FDA issued another statement saying that amalgam was unequivocally safe for everyone. Somehow, somewhere in the reaches of government and the Health and Human Services Administration, this amendment to the FDA rule was killed.

Here is the full text of the original, 2012 proposed rule:

FDA Safety Communication: Reducing Exposure to Mercury Vapor Released From Dental Amalgam (“Silver Fillings”)

HHS has not allowed FDA to release this safety warning. The most vulnerable continue to be harmed by a hidden river of mercury poisoning installed without our knowledge or consent.

Please sign the Petition for Medical and Dental Device Safety Urgent Reform (MEDDSURGE).

MD+DI DeviceTalk: Lawsuit Tells How Politics Trump FDA's 'Gold Standard' on Mercury Fillings

MD+DI: Lawsuit Tells How Politics Trump FDA’s “Gold Standard”

Jim Dickinson August 3, 2015

FDA tarnishes its reputation as the regulatory "gold standard" with its stance on mercury-based dental amalgam.

..."Copiously documented with legal, regulatory, and scientific exhibits, the 28-page Washington complaint supplements a 16-month-old lawsuit that FDA has been trying to ignore from the International Academy of Oral and Medical Toxicology and other mercury-opposed plaintiffs who, on other fronts, are winning as the archaic amalgam market in U.S. dentistry dwindles in favor of non-mercury composite resin alternatives.

The darkest tarnish on FDA’s illusory gold glitter could be the new complaint’s discovery that after the agency in 2012 dutifully sent to its political bosses at HHS a scientifically-based final decision restricting mercury amalgam’s use in dentistry, FDA mysteriously reversed course.

That final decision remained a secret, internal document until by a process unexplained in the complaint, it came into the hands of the plaintiffs’ lawyers, enabling them to compare what FDA had decided to tell the world about amalgam and what it was diverted from above to say instead. It did this last January in deceptive responses to three petitions from plaintiffs for a ban on amalgam."...

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

Robert Lowes  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."...