
For over 33 years the FDA dodged properly classifying dental mercury amalgam as it was grandfathered in without proof of safety. In 2007 the FDA lost a lawsuit which forced them to classify dental amalgam. Unfortunately the FDA chose not to perform even the preliminary requirements of classification such as an environmental assessment. The final rule of the FDA classification was a huge disappointment as it declared mercury amalgam to be safe for anyone and everyone, without regard to age, reproductive status, or any of the known factors that make a person unusually susceptible to the effects of mercury exposure.
Attorney Jim Love explains
The Petition For Reconsideration
which forced the FDA to reconsider
its 2009 amalgam rule.
Although the FDA ruling purported to be a ‘risk assessment’, the document was nothing of the sort as it did not comply with the standards of practice endorsed and espoused by the professional risk assessment community.
The International Academy of Oral Medicine and Toxicology (IAOMT), a scientific organization made up ofdental, medical and research professionals submitted a petition for reconsideration to the FDA in September of 2009. This petition pointed out the inaccuracies, inconsistencies and flawed science the FDA relied upon, and urged them to reconsider their ruling. The FDA held a new dental products panel meeting in December 2010, specifically to further investigate and re-evaluate the issues brought up in the petition for reconsideration.
DOWNLOADS
[rokdownload menuitem="287" downloaditem="105" direct_download="false"]PETITION FOR RECONSIDERATION[/rokdownload]
CONTACT
- James M. Love
- TITUS HILLIS REYNOLDS LOVE DICKMAN & McCALMON, P.C.
- 3700 First Place Tower 15 East Fifth Street
- Tulsa, Oklahoma 74103-4334
- Robert E. Reeves
- REEVES & ASSOCIATES
- 1310 First National Building 167 West Main Street
- Lexington, KY 40507
[readon url="index.php?option=com_content&view=article&id=183&Itemid=261"]Decision Involved[/readon]
