UPDATE: FDA Issues Final Regulation on Dental Amalgam
The U.S. Food and Drug Administration today (July 28, 2009) 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. Accoring to a recent Simply Dental Chatswood blog post this news will not be changing much for their office, as they like many concerned proffesionals of the industry, have begun to remove amalgam fillings from their repertoire some time ago. However, it is not the case across the board.
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:
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- A warning against the use of dental amalgam in patients with mercury allergy;
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- 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.
Original press release on the FDA’s site.
Not the result that was hoped for. Original article follows.
Congress and the FDA may finally be doing something about the serious public health risk of mercury in amalgam dental fillings. They are seeking comment on people’s experiences related to amalgam (“silver”) fillings. Unfortunately, this may be a bit late for many to get their comments in. They are due by July 28. I just found out about this today.
See Consumers for Dental Choice and The International Academy of Oral Medicine and Toxicology for all the information and updates.
Please read everything carefully before contributing. For anyone who may have questions or concerns about fillings they have, the IAOMT and Consumers for Dental Choice sites are great resources.
The initial letter from Consumers for Dental Choice and some additional background information is below.
Some mainstream media coverage:
For those who do not know, I had a very bad experience with a dentist in Seattle many years ago with some dental work that went very wrong and I got very sick for several weeks from mercury poisoning. I’ve since had all of my amalgam fillings removed and feel great.
Thanks for reading,
Marc Arsenault
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AFTER A 32 YEAR DELAY – FDA MUST CLASSIFY DENTAL AMALGAM!!
YOUR COMMENTS ARE A MUST!
After a 32 year delay to classify pre-encapsulated mercury amalgam dental fillings, the Food & Drug Administration (FDA) has been mandated by U.S. District Court to classify the components of dental amalgam by July, 2009.
Prior to classification, FDA has reopened the public comment period concerning the risks of dental amalgam with a deadline for submissions of July 28, 2008.
If you have commented previously, it is still crucial that you submit again, as only these comments will be considered for this Docket period.
Docket ID: FDA-2008-N-0163
Docket Title: Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Reopening of Comment Period to July 28, 2008.
To file an electronic comment: Click here »
Go to the bottom of the page with heading “Submitter Information”. Fill out the form, enter your comments, and click the “Next Step” button. Then you will be able to cancel, edit your comments, or submit them using the buttons on the bottom of the page.
To fax a written comment: Fax: 301.827.6870
To mail a comment:
Division of Dockets Management (HFA-305)
FDA
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Please consider sending a copy of your submission to: info@toxicteeth.org so that Consumers for Dental Choice has a record of all comments. Please use subject line: “My comment to FDA”.
To view comments: 1) Go to http://www.regulations.gov 2) In the search box enter FDA-2008-N-0163. We have been informed that private citizen comments will not be posted on the website, however they will be reviewed.
Suggestion : If you are an injured consumer: Submit your first and last name with subject: “ I am a victim of mercury poisoning from my amalgam dental fillings and I want the use of mercury in dentistry banned”.
Let the FDA know that it is time to protect the public not the dental industry.
BAN DENTAL AMALGAM FILLINGS NOW!
Points to consider in your submission:
Dental amalgam must be classified as Class III, not Class II so that manufacturers have to prove the safety of amalgam. Class II does not require this regulation.
Amalgam manufacturers should be mandated to provide an environmental impact statement to prove amalgams are environmentally safe. Mercury from dental offices contributes at least 40% of the mercury to wastewater, as well as contributing to air pollution from crematoriums.
Include your personal stories including: dental revisions and additional dental costs due to corrosion and break down of amalgam fillings and health related illnesses and medical costs due to mercury toxicity. (Please do not include personal information such as social security numbers).
This Spring we won a lawsuit against the FDA for not classifying dental amalgam after a 32 year stand off. As a result, FDA had to revise the information on their website related to the risks of dental amalgam, now admitting that amalgam fillings are a potential risk to pregnant women, children and a sensitive sub-population. See: FDA’s website: http://www.fda.gov/cdrh/consumer/amalgams.html.
DEMAND THAT CHILDREN BE PROTECTED BY BANNING THE USE OF DENTAL AMALGAM NOW!!
SAFE WHITE ALTERNATIVE FILLINGS EXIST!
MERCURY AMALGAMS, CONSIDERED TO BE A HAZARDOUS WASTE PRODUCT, DOES NOT BELONG IN THE HUMAN BODY!
PLEASE DON’T DELAY – WRITE TODAY!! DEADLINE – July 28, 2008.
Thank you.
Consumers for Dental Choice
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Background:
Many people do not realize the “silver” amalgam fillings are 50% mercury. A large filling may contain as much mercury as a thermometer. Mercury vaporizes easily at room temperature, and in this state, is odorless, colorless and tasteless. Inhaled mercury vapor is readily absorbed into the bloodstream. The World Health Organization has concluded that dental fillings contribute more mercury to a person’s body than all other sources of mercury combined. Mercury is a powerful poison. Published research demonstrates that mercury is more toxic than lead, cadmium or arsenic. No amount of exposure to mercury vapor can be considered harmless. Especially considering its cumulative effect.
Mercury is the most toxic, non-radioactive element on the earth. Most medical and scientific researchers have called for a ban on the use of mercury in all products. However, the potential harmful effects of mercury fillings have been ignored by the U.S. Government. Due to its poisonous nature, mercury can adversely affect the immune, urinary, cardiac, respiratory and digestive systems. Under laboratory conditions, mercury has produced brain cell deterioration identical to that seen in victims of Alzheimer’s disease.
Consumers for Dental Choice (CDC) was established in 1996 by consumer advocates, mercury poisoning victims, scientists and mercury-free dentists, and soon thereafter became a 501(c)(3) nonprofit corporation. Our purpose is to educate the public about the health and environmental dangers of mercury fillings, and to ensure more effective government oversight on amalgam. Since the organization began, the number of amalgams placed have declined dramatically, from two-thirds of all fillings placed to one-third, and the number of mercury-free dentists has grown dramatically. But we will not be satisfied until mercury is no longer used in dentistry.
As part of its educational work, Consumers for Dental Choice wants the full flow of non-deceptive information between dentists and patients. As such, we work to end the American Dental Association’s notorious “gag rule” which tries to silence mercury-free dentists, and the ADA’s promoting mercury amalgam under the deceptive term “silver.” We favor full disclosure of the risks of mercury fillings.
It is important that research relied upon by federal agencies be based on science, so Consumers works to counter studies by non-independent or unqualified researchers that urge continuation of amalgam for spurious reasons such as “it’s good because we’ve used it for 150 years,” or a mixture of amalgam is like sodium and chloride is like table salt. Scientific research makes clear that mercury does not belong in dentistry.
According to reports made by Canyon Rim Dental, the environmental dangers of mercury fillings – from dental offices, from human waste, and from cremation – is alarming, and reason enough to end the use of amalgam. Consumers works to educate the public about the contribution of dentistry of toxic mercury to both human beings and the environment.
The International Academy of Oral Medicine and Toxicology
In 1984, thirteen dentists were discussing a seminar they had just attended on the dangers of mercury from dental amalgam fillings. They agreed that the subject was alarming. They also agreed that the seminar, though long on fireworks, was short on science, and if there really was a problem with dental mercury, the evidence ought to be in the scientific literature. So, like thirteen musketeers vowing “all for one and one for all,” they set out to find the evidence, or failing that, to sponsor new research that would provide the answers they sought.
Over two decades later, the IAOMT has grown to over 500 active members in North America, with affiliated chapters in fourteen other countries. The years have been very fruitful, as the Academy and its members have chronicled and promoted the research that has proven beyond a reasonable doubt that dental amalgam is a source of significant mercury exposure, and a hazard to health. It has taken the lead in educating dentists and allied professionals in the methods of safely dealing with amalgam fillings, and safely disposing the waste. It has also led the way in developing more biocompatible approaches in other areas of dentistry, including endodontics, periodontics, and disease prevention. All this while maintaining the motto, “Show me the science!”
A more biocompatible approach is the hallmark of “biological dentistry.” In using that term, we are not attempting to stake out a new specialty for dentistry, but to describe an attitude that can apply to all facets of dental practice, and to health care in general: to always seek the least toxic way to accomplish the mission of treatment, to do it while treading as softly as possible on the patient’s biological terrain.
