Tuesday, October 26, 2010
Dental Amalgam and FDA
IAOMT News
FDA Classification Disaster: Back
7/30/2009
FDA NEWS RELEASE
For Immediate Release: July 28, 2009
Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Issues Final Regulation on Dental Amalgam
The U.S. Food and Drug Administration today issued a final regulation classifying dental amalgam and its component parts – elemental mercury and a powder alloy—used in dental fillings. While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients.
The regulation classifies dental amalgam into Class II (moderate risk). By classifying a device into Class II, the FDA can impose special controls (in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk) to provide reasonable assurance of the safety and effectiveness of the device.
The special controls that the FDA is imposing on dental amalgam are contained in a guidance document that contains, among other things, recommendations on performance testing, device composition, and labeling statements.
Specifically, the FDA recommended that the product labeling include:
A warning against the use of dental amalgam in patients with mercury allergy;
A warning that dental professionals use adequate ventilation when handling dental amalgam;
A statement discussing the scientific evidence on the benefits and risk of dental amalgam, including the risks of inhaled mercury vapor. The statement will help dentists and patients make informed decisions about the use of dental amalgam.
Dental amalgam is a “pre-amendment device,” which means that it was in use prior to May 28, 1976, when the FDA was given broad authority to regulate medical devices. That law required the FDA to issue regulations classifying pre-amendment devices according to their risk into class I, II, or III. Although the FDA previously had classified the two separate parts of amalgam – elemental mercury and the metal powder alloy – it had not issued a separate regulation classifying the combination of the two, dental amalgam. During this time, however, dental amalgam has been subject to all applicable provisions of the law.
Today’s regulation also reclassifies the mercury component of dental amalgam from Class I (low risk) to Class II (moderate risk).
Over the past six years, the FDA has taken several steps to assure that the classification of dental amalgam is supported by strong science.
In 2002, the agency issued a proposed rule to classify dental amalgam and identify any special controls necessary for its safe and effective use.
Due to a high number of comments on that rule, the agency held an advisory committee meeting in 2006, inviting dental and neurology experts to review existing scientific data on dental amalgam, especially with regard to its toxicity in pregnant women and children.
The agency drafted a review of recent and relevant peer-reviewed scientific literature on exposure to dental amalgam mercury. The advisory committee asked that the agency conduct an even deeper review of the scientific literature on this topic. In all, the agency considered some 200 scientific studies.
On April 28, 2008, the FDA reopened the comment period on the 2002 proposed classification in order to elicit the most up-to-date comments and information related to classification of dental amalgam. Today’s rule reflects the years of agency review on this topic.
FDA’s Web site on dental amalgam:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/default.htm
__________________________________________________________________________________________
IAOMT Response
On Tuesday, July 28, 2009, the FDA completed its classification of the traditional dental amalgam filling material by making it a Class II device, with minimal controls. Dr. Susan Runner, the acting director of the dental devices division, stated flatly that there are no serious concerns about the toxic mercury exposure from amalgam, that is in fact thoroughly documented in the scientific literature.
The International Academy of Oral Medicine and Toxicology (IAOMT), a group of dental, medical and research professionals dedicated to raising the standards of biocompatibility in dental practice, completely rejects the FDA’s action. Dental amalgam is universally acknowledged to expose people to mercury, but by making it a class II device, the FDA has passed on the opportunity to demand proof of safety from its manufacturers. Instead it has been declared safe by administrative fiat, in contradiction to the vast body of scientific evidence attesting to its hazardous nature, and in contradiction to its own expert panel, which voted in 2006 to reject claims of amalgam safety.
The FDA has obviously been influenced more by outside pressure than by the scientific standards that have produced other mercury warnings – about mercury from thermometers, or from excess consumption of fish – sources that clearly provide a lower risk of exposure in the general population than mercury dental filings.
The “controls” included in this classification have no force, and can be ignored at will by any dentist. There is no real protection from mercury exposure here for children and unborn fetuses.
The FDA actions of this past year have at least served the public by breaking open the old dirty secret about amalgam fillings – that they are composed mostly of mercury, and that they provide exposure and risk to children and other sensitive groups.
The IAOMT will continue to fight this unwise policy by all legal means.
Stephen M. Koral, DMD
President, IAOMT
www.IAOMT.org
Consumers for Dental Choice: Ruling Falls Short
New FDA guidelines fail to protect pregnant women and children from threat of "silver" dental fillings WASHINGTON, July 28 /PRNewswire-USNewswire/ -- In a disappointing move, the Food and Drug Administration (FDA) today did an about face in issuing a final regulation classifying dental amalgam without calling for stringent precautions for pregnant women and children. Last June, a court settlement filed by the Consumers for Dental Choice required the FDA to withdraw claims of mercury amalgam's safety from its Web site and issue an advisory indicating: "Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses."
"FDA broke its contract and broke its word that it would put warnings for children and unborn children for neurological damage," said Charles G. Brown, National Counsel for Consumers for Dental Choice, who brought the lawsuit compelling today's action. "Bowing to the dental products industry, FDA for the first time in its history pulled a warning about neurological harm to children. This contemptuous attitude toward children and the unborn will not go unanswered. We will see FDA in court."
Most consumers, and most dentists, have already switched to the main alternative, resin composite. The FDA rule destroys a dental myth that the mercury becomes inert in the mouth; FDA says the vapors from dental mercury go into the human body. Due to mercury waste, amalgam is also increasingly targeted by environmentalists.
Intense interest in the rule exists on Capitol Hill. Congresswoman Diane Watson (D-CA) and Congressman Dan Burton (R-IN) co-authored a letter to FDA in May, signed by 19 Members of Congress, calling for a rule to protect children and young women from amalgam. In July, they introduced a resolution on the issue with 29 co-sponsors (H.Res. 648).
Amalgam has also become controversial because the middle-class has largely moved to non-toxic alternatives while the poor, minorities, and institutional recipients, such as soldiers and prisoners, still get amalgam.
"FDA remains alone in the world in failing to protect children and pregnant women from mercury fillings. Since 1996, Canadian dentists have been told not to put mercury amalgam in children or pregnant women. Since 1998, British dentists have been told the same for pregnant women. Norway and Sweden have banned amalgam altogether. Regrettably, this rule should have meant the end of two-tiered dentistry: mercury for the poor and choice for the rest. Instead the FDA has failed to carry out its mission of protecting the public health," concluded Brown.
FDA Classification Disaster: Back
7/30/2009
FDA NEWS RELEASE
For Immediate Release: July 28, 2009
Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Issues Final Regulation on Dental Amalgam
The U.S. Food and Drug Administration today issued a final regulation classifying dental amalgam and its component parts – elemental mercury and a powder alloy—used in dental fillings. While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients.
The regulation classifies dental amalgam into Class II (moderate risk). By classifying a device into Class II, the FDA can impose special controls (in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk) to provide reasonable assurance of the safety and effectiveness of the device.
The special controls that the FDA is imposing on dental amalgam are contained in a guidance document that contains, among other things, recommendations on performance testing, device composition, and labeling statements.
Specifically, the FDA recommended that the product labeling include:
A warning against the use of dental amalgam in patients with mercury allergy;
A warning that dental professionals use adequate ventilation when handling dental amalgam;
A statement discussing the scientific evidence on the benefits and risk of dental amalgam, including the risks of inhaled mercury vapor. The statement will help dentists and patients make informed decisions about the use of dental amalgam.
Dental amalgam is a “pre-amendment device,” which means that it was in use prior to May 28, 1976, when the FDA was given broad authority to regulate medical devices. That law required the FDA to issue regulations classifying pre-amendment devices according to their risk into class I, II, or III. Although the FDA previously had classified the two separate parts of amalgam – elemental mercury and the metal powder alloy – it had not issued a separate regulation classifying the combination of the two, dental amalgam. During this time, however, dental amalgam has been subject to all applicable provisions of the law.
Today’s regulation also reclassifies the mercury component of dental amalgam from Class I (low risk) to Class II (moderate risk).
Over the past six years, the FDA has taken several steps to assure that the classification of dental amalgam is supported by strong science.
In 2002, the agency issued a proposed rule to classify dental amalgam and identify any special controls necessary for its safe and effective use.
Due to a high number of comments on that rule, the agency held an advisory committee meeting in 2006, inviting dental and neurology experts to review existing scientific data on dental amalgam, especially with regard to its toxicity in pregnant women and children.
The agency drafted a review of recent and relevant peer-reviewed scientific literature on exposure to dental amalgam mercury. The advisory committee asked that the agency conduct an even deeper review of the scientific literature on this topic. In all, the agency considered some 200 scientific studies.
On April 28, 2008, the FDA reopened the comment period on the 2002 proposed classification in order to elicit the most up-to-date comments and information related to classification of dental amalgam. Today’s rule reflects the years of agency review on this topic.
FDA’s Web site on dental amalgam:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/default.htm
__________________________________________________________________________________________
IAOMT Response
On Tuesday, July 28, 2009, the FDA completed its classification of the traditional dental amalgam filling material by making it a Class II device, with minimal controls. Dr. Susan Runner, the acting director of the dental devices division, stated flatly that there are no serious concerns about the toxic mercury exposure from amalgam, that is in fact thoroughly documented in the scientific literature.
The International Academy of Oral Medicine and Toxicology (IAOMT), a group of dental, medical and research professionals dedicated to raising the standards of biocompatibility in dental practice, completely rejects the FDA’s action. Dental amalgam is universally acknowledged to expose people to mercury, but by making it a class II device, the FDA has passed on the opportunity to demand proof of safety from its manufacturers. Instead it has been declared safe by administrative fiat, in contradiction to the vast body of scientific evidence attesting to its hazardous nature, and in contradiction to its own expert panel, which voted in 2006 to reject claims of amalgam safety.
The FDA has obviously been influenced more by outside pressure than by the scientific standards that have produced other mercury warnings – about mercury from thermometers, or from excess consumption of fish – sources that clearly provide a lower risk of exposure in the general population than mercury dental filings.
The “controls” included in this classification have no force, and can be ignored at will by any dentist. There is no real protection from mercury exposure here for children and unborn fetuses.
The FDA actions of this past year have at least served the public by breaking open the old dirty secret about amalgam fillings – that they are composed mostly of mercury, and that they provide exposure and risk to children and other sensitive groups.
The IAOMT will continue to fight this unwise policy by all legal means.
Stephen M. Koral, DMD
President, IAOMT
www.IAOMT.org
Consumers for Dental Choice: Ruling Falls Short
New FDA guidelines fail to protect pregnant women and children from threat of "silver" dental fillings WASHINGTON, July 28 /PRNewswire-USNewswire/ -- In a disappointing move, the Food and Drug Administration (FDA) today did an about face in issuing a final regulation classifying dental amalgam without calling for stringent precautions for pregnant women and children. Last June, a court settlement filed by the Consumers for Dental Choice required the FDA to withdraw claims of mercury amalgam's safety from its Web site and issue an advisory indicating: "Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses."
"FDA broke its contract and broke its word that it would put warnings for children and unborn children for neurological damage," said Charles G. Brown, National Counsel for Consumers for Dental Choice, who brought the lawsuit compelling today's action. "Bowing to the dental products industry, FDA for the first time in its history pulled a warning about neurological harm to children. This contemptuous attitude toward children and the unborn will not go unanswered. We will see FDA in court."
Most consumers, and most dentists, have already switched to the main alternative, resin composite. The FDA rule destroys a dental myth that the mercury becomes inert in the mouth; FDA says the vapors from dental mercury go into the human body. Due to mercury waste, amalgam is also increasingly targeted by environmentalists.
Intense interest in the rule exists on Capitol Hill. Congresswoman Diane Watson (D-CA) and Congressman Dan Burton (R-IN) co-authored a letter to FDA in May, signed by 19 Members of Congress, calling for a rule to protect children and young women from amalgam. In July, they introduced a resolution on the issue with 29 co-sponsors (H.Res. 648).
Amalgam has also become controversial because the middle-class has largely moved to non-toxic alternatives while the poor, minorities, and institutional recipients, such as soldiers and prisoners, still get amalgam.
"FDA remains alone in the world in failing to protect children and pregnant women from mercury fillings. Since 1996, Canadian dentists have been told not to put mercury amalgam in children or pregnant women. Since 1998, British dentists have been told the same for pregnant women. Norway and Sweden have banned amalgam altogether. Regrettably, this rule should have meant the end of two-tiered dentistry: mercury for the poor and choice for the rest. Instead the FDA has failed to carry out its mission of protecting the public health," concluded Brown.
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