Text of FDA’s Actual 2012 Amalgam Safety Proposal

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

  • 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
  • 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”)

2017-10-30T21:54:33+00:00