This Petition pertains to dental mercury capsules (herein after sometimes referred to as “mercury fillings” or “dental amalgam.”) It is hereby requested that the Commissioner of the Food and Drug Administration (“FDA”) take the following actions with respect to mercury fillings:
- Formally ban the use of encapsulated mercury fillings as a dental restorative material pursuant to section 516 of the Medical Device Amendments of 1976 (21 U.S.C. 360f) and 21C.F.R. 895. The risk of illness or injury associated with the use of dental mercury presents an unreasonable, direct and substantial danger to the health of dental patients as well as dental personnel. Mercury fillings potentially endanger the health of individuals who have been or will be exposed to dental mercury.
- Alternatively, place encapsulated mercury fillings into Class III pursuant to section 513(3) of the Act (21 U.S.C. 360 c(e)) and 21 CFR 860, and seek strict proof of safety and effectiveness.
- If the FDA decides to place encapsulated mercury fillings into Class III, FDA should place restrictions (not special controls) on the use of this material in young children, women and particularly women of childbearing age, males, patients with compromised kidney, immune, and neurological function, those who are hypersensitive to mercury, those who test positive for apolipoprotein E4 or coproporphyrinogen oxidase (CPOX4), and other persons within susceptible subpopulations as described herein. Neither “Class II controls” nor “Special Controls” can accomplish a reasonable assurance of safety for all sectors of our general population. Reasonable assurance of safety can only be achieved by abolishing the use dental amalgam or by placing it into Class III.
- Under any of the foregoing alternatives, to require that an Environmental Impact Statement, or at least, an Environmental Assessment be prepared pursuant to 21 CFR 25.40 and NEPA.