Author: Larose P, Koral S, Kall J, Smith K, Love J
Source: IAOMT
Year: 2008
Comment:
On July 28, 2008, the IAOMT submitted this public comment to the FDA demanding dental mercury amalgam be classified in conformance with the mandate of the Medical Device Amendments of 1976. Nearly a year later, IAOMT also filed a Citizen’s Petition to influence FDA policy-making on amalgam. A few days later, on July 28, 2009, FDA announced it was classifying dental mercury amalgam for the first time in Class II without requiring any significant special controls.
Abstract / Excerpt:
“Dental mercury-silver amalgam must not be classified in Class II, which would effectively confer “generally regarded as safe” status. It is not safe. The IAOMT position is that amalgam should be banned, removed from the market just as every other mercurial medical device and substance has been. At the very least, it should be placed in Class III, and let the advocates prove that it is safe. We are confident that such proof is not available. Mercurial wound disinfectants are gone, mercurial diuretics are gone, mercury thermometers are gone, and so are all mercurial veterinary substances. There is no magic that makes dental mercury safer than those obsolete products of the past. In this era when the public worries about the mercury they are ingesting through fish consumption, the FDA should do the right thing and ban amalgam dental fillings as the time-release mercury exposure devices they are. ”
Citation:
Larose P, Koral S, Kall J, Smith K, Love J. Public Comment to the FDA Proposed Classifi cation of Mixed Encapsulated Dental Amalgams. ChampionsGate, FL: International Academy of Medicine and Toxicology. July 28, 2009. http://iaomt.org/wp-content/uploads/article_FDAcomment.pdf