By Dr. Mercola
Has the FDA officially gone mad?
The products in question are primarily skin lighteners and anti-aging treatments, most of which are manufactured overseas and sold illegally in the United States.
"Exposure to mercury can have serious health consequences," says Charles Lee, M.D., a senior medical advisor at FDA.
"It can damage the kidneys and the nervous system, and interfere with the development of the brain in unborn children and very young children."
... "You don't have to use the product yourself to be affected, says FDA toxicologist Mike Bolger, Ph.D.
"People—particularly children—can get mercury in their bodies from breathing in mercury vapors if a member of the household uses a skin cream containing mercury."
Infants and small children can ingest mercury if they touch their parents who have used these products, get cream on their hands and then put their hands and fingers into their mouth, which they are prone to do, adds Bolger."
This is a remarkable admission from an agency that repeatedly has refused to acknowledge the dangers inherent with dental amalgams, which contain about 50 percent mercury—not silver, as the name "silver fillings" might have you believe.
What Can Be More Dangerous than Implanting a Neurotoxin in Your Mouth?
The American Dental Association (ADA) at one time owned the patent for mercury fillings. Both the ADA and FDA have fraudulently been using the term "silver fillings" for decades. This is why so few people realize they're actually walking around with, in some cases, sizeable amounts of mercury in their teeth! An estimated 75 percent of Americans are ignorant about that fact that half of each amalgam filling is mercury, and this is clearly the result of the ADA's tactical move to popularize the term "silver fillings."
The FDA even removed the following statement from its website: "Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses."
According to Charlie Brown, national counsel, Consumers for Dental Choice:
"To conceal the mercury from America's parents and consumers, the American Dental Association promoted amalgam as "silver fillings." The term is a gigantic fraud; amalgam has twice as much mercury as silver. In Spanish amalgam is similarly promoted fraudulenty, as "amalgama plata". The ADA's partner in perpetuating this cover-up is the U.S. Food and Drug Administration, who cleverly, but deceitfully, says they are called "silver" because of the color. . The FDA knows better. " Gold fillings are called gold because of their material, not color. Under the dictionary definition of "silver," the primary meaning if the material, with money second, silverware third, and the color fourth or fifth. That our nation's consumer protection agency on devices unabashedly takes the side of the promoter of a consumer fraud is profoundly troubling.
If the presence of mercury in skin cream warrants this kind of prominent action from the FDA, why does the agency refuse to address concerns about placing 1-2 grams of dental amalgam, half of which is mercury, into the mouths of children and pregnant women? A decade ago state Medicaid programs promised to pay for any material, but Connecticut recently decided that low-income families must now choose between mercury fillings and no fillings. For children with disabilities in Philadelphia, for prisoners in California, for Native Americans on reservations, it is is ths same dismal choice: mercury in the mouth, or no dental care...
Dental Amalgam = Continuous Exposure to Mercury
It's important to realize that once you get an amalgam filling, you're continually exposed to mercury. Every time you chew, the filling releases mercury vapor into your mouth that deposits and accumulates in your tissues over time. Mercury vapors readily pass through cell membranes, across your blood-brain barrier and into your central nervous system, where it causes psychological, neurological, and immunological problems. Children and fetuses, whose brains are still developing, are most at risk, but really anyone can be impacted.
A 1999 report from the Agency of Toxic Substances and Disease Registry, a division of the U.S. Department of Health and Human Services, suggested dental amalgams may account for as much as 75 percent of a person's daily mercury exposure. And the World Health Organization (WHO) has stated that between 3-17 micrograms of mercury are released into the body each day by chewing, compared to only 2-5 micrograms from fish and all other environmental sources combined. An editorial in The New England Journal of Medicine also stated that dental amalgams were "possibly the chief source of exposure [to mercury] of a large segment of the U.S. population ii".
Why is the FDA and ADA Protecting the Use of Mercury in Dentistry?
The 2008 Obama/Biden Plan for a Healthy America stressed preventive approaches to disease, including the reduction of toxins. Chief among these toxins was mercury. In their final report on dental amalgam, Future Use of Materials for Dental Restorationiii, the World Health Organization (WHO) also took a firm stance againstthe use of mercury in dentistry. In it, WHO states that amalgam "has been associated with general health concerns" and releases a "significant amount of mercury" into the environment. It also notes that alternatives to amalgam are readily available.
Still, nothing has been done so far to eliminate one of the primary sources of exposure in the US, namely dental amalgams.
Other countries are faring much better. Many are already protecting vulnerable populations, especially children, from exposure to amalgam. For example:
- The 47 nations of the Council of Europe passed a resolution calling on the nations to start "restricting or prohibiting the use of amalgams as dental fillings," explaining that "amalgams are the prime source of exposure to mercury for developed countries, also affecting embryos, fetuses (through the placenta) and children (through breastfeeding).
- Australia's National Health & Medical Research Council (NHMRC) says amalgam should be avoided in pregnant women, nursing mothers, children, and people with kidney disease.
- Health Canada directed its dentists to stop using amalgam in children, pregnant women, and people with impaired kidney function – way back in 1996.
- Germany's federal court has ruled that dentists who use mercury fillings can face legal liability.
After an ongoing and vigorous campaign to educate Americans on the dangers of dental amalgams, it looked promising when Jeff Shuren, Director of FDA's Center for Devices, finally promised an announcement on the amalgam rule by end of 2011. But, his promise fell flat. With just minutes to go before the end of the work year, the agency declared it would not issue a statement about mercury fillings When pressed by the trade press, FDA added that it has no plans and no timetable – and may never do anything...
Is it possible that the stated safety of mercury fillings just a big lie to protect the massive liability the ADA, dentists, and mercury filling manufacturers would be exposed to if the FDA would admit mercury fillings actually cause harm?
Is this absolute proof the FDA is willing to accept harm to patients to protect corporate interests?
The mission of the FDA is to protect consumers and patients, but it's extremely difficult to believe in the case of mercury... Sure, the agency tries to show it cares by coming down hard on a few little guys—rogue skin cream companies that don't have well-paid lobbyists on The Hill. But when faced with powerful corporate interests, the FDA does nothing.
The Revolving Doors Between the FDA and Various Industries...
FDA Commissioner Margaret Hamburg could perhaps shed some light on the issue. She participated in the rule making even though she's a former director and board member of Henry Schein, the largest provider of professional dental products.
According to Charlie Brown:
"In order to be appointed Commissioner, Margaret Hamburg was required to sign, and did sign, a contract promising not to work on any matter affecting Schein Inc. while holding its stock or stock option. While still holding Schein stock option, she worked on the amalgam rule. Specifically, she insisted on a staff meeting with her on July 1, 2009, to shape the pending amalgam rule; this meeting plainly violated her written promise. Records of the 7/1/09 meeting were heavily redacted before being turned over to me.
I wrote the Commissioner three times to ask her to get out of the rule-making process; my letters were ignored until a minor media hubbub occurredt. Hamburg perhaps disqualified herself at that point – or perhaps not, because she never filed a disqualification letter, and FDA refuses to say the date she stopped working on the amalgam rule. In any case, she continued to correspond secretly with Schein's general counsel (on her private email account) through the entire rule-making process. Immediately after the rule was announced, Schein's general counsel said the company is "indebted to you"; the following week Schein's CEO praised the FDA Commissioner for providing "insights" to Schein board members -- fully five months after she took office."
In short, it would appear FDA Commissioner Margaret Hamburg never really stopped working for Henry Schein Inc...
Jim Dickinson, editor of FDA Webview, wrote an insightful editorial concerning FDA's intransigence in his March 8 post, titled 180 Degrees: FDA's 2 Faces on Mercury Risksiv.
"When you're daubing on mercury skin creams and cosmetics, FDA wants you to know how toxic the mercury vapor coming from them can be not only to you but everyone near you, especially infants and children. But when your dentist is jamming mercury amalgam into your teeth, and contrary to increasing evidence to the contrary, FDA on its Web site wants you know that it "has reviewed the best available scientific evidence to determine whether the low levels of mercury vapor associated with dental amalgam fillings are a cause for concern. Based on this evidence, FDA considers dental amalgam fillings safe for adults and children ages 6 and above."
... Asked to explain the apparent contradiction in the agency's position on mercury safety, and specifically asked if there were dosage exposure differences between the two kinds of mercury products, FDA ducked the issue. Press officer for cosmetics, Siobhan DeLancey replied: "I don't handle the dental side, but I am copying Michelle Bolek, who handles dental amalgam issues."
Bolek passed it to Morgan Liscinski, who five hours later answered: "We have no further comment regarding the issue of dental amalgam."
The obvious difference between the two FDA postures could be that in the unapproved imported creams and cosmetics case, no powerful industry that has clout at HHS could be offended by hostile FDA action, while in the dental amalgam case, powerful interests (e.g. the pro-mercury 156,000-member American Dental Association and commissioner Margaret Hamburg's former investment interest, leading amalgam distributor Henry Schein, Inc.) probably do have clout at HHS and could well be offended by FDA action against amalgam."
What You Can Do to Help Abolish Mercury Amalgams
Charlie Brown, who runs Consumers for Dental Choice, has just returned from Brussels, where he addressed an European Union (E.U.) proposal to ban dental mercury in all 27 of the E.U.'s member nations.
As we have written, FDA even ignores its own scientists. I urge you to write or call out the Director of FDA's Center for Devices, Jeff Shuren on this issue. Ask him why the FDA continues to ignore scientists and covers up the mercury from American parents and consumers. Ask when the FDA is going to get in step with the world on mercury...
Dr. Jeff Shuren, Director
Center for Devices, U.S. Food & Drug Admin.
10903 New Hampshire Ave.
WO66-5431, Room 5442
Silver Spring, MD 20993-0002
To keep up the fight to end mercury in dentistry around the world, once and for all, I also encourage you to contribute to Consumers for Dental Choice. Donations can be made online at www.toxicteeth.org/donate.cfm. (Consumers for Dental Choice, is a 501(c)(3) non-profit organization dedicated to advocating mercury-free dentistry. Contributions are tax-deductible in the U.S.)
Checks can be mailed to:
Consumers for Dental Choice
316 F St., N.E., Suite 210
Washington DC 20002
Also, for timely updates and information, please join Consumers for Dental Choice on Facebook.