FDA Shamed in Media for Slow
Reaction on Mercury
October 06, 2015
Story at-a-glance
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In 2013, US Secretary of State, John Kerry, signed
the Minamata treaty on mercury on behalf of the US
government, which includes a pledge to phase down
dental amalgam, effective immediately
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The FDA’s 2009 rule on amalgam, which supports the
continued, if not increased, use of mercury fillings
is in direct violation of the Minamata Convention
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60 American and foreign environmental groups have
sent a letter to the Secretary of State, urging him
to “take a leadership role in encouraging FDA to
reduce amalgam use”
By Dr. Mercola
Amalgam, typically referred to as "silver fillings," is a
consumer fraud perpetuated by those who, through the years, have
stood to gain from its continued sale.
This includes the American Dental Association Health
Foundation, the non-profit research arm of the American Dental
Association (ADA), which held patents on two (now expired)
amalgam formulations (patent numbers: US04078921 and
US04018600).
By referring to the color of the compound rather
than its content, consumers have been kept in the dark
about the fact that they're placing a known neurotoxin — mercury
— into their teeth.
As noted in a 2010 scientific review1
on mercury exposure and children's health, there is no known
safe level of exposure for mercury.
Ideally, exposure should be zero, so those who insist
amalgams — which are 50 percent mercury — pose no threat to
health are not acting in an ethical or responsible manner.
Amalgams Release Mercury Vapors
Dental amalgams readily release mercury vapors whenever you
chew or brush your teeth, which pass through your cell
membranes, across your blood-brain barrier, and into your
central nervous system.
Effects can be psychological, neurological, and/or
immunological.
One 2012 study2
evaluating the
effects of mercury on cognition in adults found that mild
impairment was evident at blood mercury levels of 5 to 15 µg/L.
Above 15 µg/L, cognition was significantly impaired.
Most people are aware that mercury is hazardous to health,
but if they don't know that amalgam fillings contain
mercury, then they can't object to it in the first place.
FDA Has Failed to Address Amalgam Fraud
In a report titled, "Measurably
Misleading,"3
Consumers for Dental Choice, led by Charlie Brown, reveals how
the dental industry and the FDA have deceived you about amalgam.
According to a Zogby poll, 57 percent of Americans are
unaware that amalgam contains mercury; 23 percent believe
amalgam is made of silver.
This is clear proof that the deceptive use of the term
"silver filling" has worked as intended. Moreover, according to
this poll, only 11 percent of people were informed by their
dentist that amalgam contains mercury.
The FDA is responsible for addressing consumer fraud that
occurs in medicine and health. But when it comes to
mercury fillings, the agency has refused to take corrective
action. In fact, the agency has and continues to support the
deceptive marketing of mercury amalgams as "silver fillings."
FDA Also Broke Law By Refusing to Classify Amalgam
The FDA also has the responsibility to determine the risk of
every medical device and to classify it accordingly. Dental
fillings are a medical device. Yet for 32 years the FDA
failed to classify mercury amalgam.
The agency broke the law, and in 2008 Charlie Brown sued the
FDA over this breach. US District Judge Ellen Huvelle convened a
hearing, and subsequently ordered the parties into mediation to
set a date by which a classification would be completed.
The FDA agreed to classify amalgam and re-write its website
by August 2009. FDA Associate Commissioner Randall Lutter and
Charlie Brown negotiated the website language line by line, and,
for the first time, the FDA issued this frank and serious
warning about amalgam:
"Dental amalgams contain mercury, which may have
neurotoxic effects on the nervous systems of developing
children and fetuses."
Conflicts of Interests Likely Influenced FDA Amalgam Rule
But then the long arm of the industry stepped in. Then
newly-appointed FDA Commissioner Margaret Hamburg4
came straight from Henry Schein, Inc., the largest seller of
dental products, including amalgam, where she'd spent five years
serving on the company's board.
To get appointed as FDA Commissioner, Hamburg was required to
sign an agreement promising to sell her Schein stock and stock
options,5
and not to participate in regulator matters affecting Schein
while owning these options.
However, not only did she retain Schein stock options, she
also allegedly continued regular correspondence with Schein's
general counsel on her private e mail.
On June 1, 2009 Charlie Brown wrote her, asking her to
confirm that she had indeed recused (disqualified) herself from
working on the pending amalgam rule. She never answered.
Instead she convened a meeting with FDA’s pro-amalgam dentist
Susan Runner, and a rule was subsequently created that allowed
for the continued concealment of mercury.
At the end of July, Runner unveiled the new rule, and the
website language Brown and Associate Commissioner Lutter had
agreed upon was replaced. By then, Hamburg had also transferred
Lutter to another agency.
After the rule was announced, Schein's general counsel wrote
to Hamburg saying that Schein is "indebted" to her for her work
as Commissioner.
The FDA's 2009 rule classifies amalgam as a Class II medical
device, which spares manufacturers from proving the product's
safety. Class III devices, which would have been a far more
appropriate classification, are considered more risky, and
require proof of safety prior to marketing.
Remarkably, the agency also said that no environmental impact
study of dental amalgam was necessary, and while claiming
amalgam is an affordable choice for low-income people, it did
not take into account the steep environmental costs of amalgam's
use...
It took another year before the tide began to turn. In 2010,
the international community gathered together in a series of
meetings to hammer out a treaty addressing all sources of
mercury pollution, including dental amalgams.
As mentioned, the treaty was finalized and signed in 2013, at
which point the FDA's outdated stance became even more
untenable.
State Department Urged to Press FDA to Curb Dental Mercury
In the summer of 2014, a group of dentists, scientists, and
patients filed a lawsuit against the FDA,6
claiming the agency "hasn't done enough to address any
potential health hazards of amalgam and that it's low income
groups... who often end up with these fillings because they
don't have a choice..."
Consumers for Dental Choice also took the issue to the US
Secretary of State, John Kerry, who signed the
Minamata treaty on mercury in 2013 on behalf of the US
government. The Minamata Convention includes a pledge to scale
down amalgam use effective immediately. The FDA’s
stance on amalgam is in direct violation of the
Minamata Convention, as its current amalgam rule actually
advocates more mercury fillings, not less!
Following the signing of the mercury treaty, Consumers for
Dental Choice created a
petition to the Secretary of State, urging him to insist the
FDA comply with the treaty, and to disclose the presence of
mercury in dental amalgam. Many of you signed this petition, and
now the movement got a major boost from 60 American and foreign
environmental groups who, in a well-publicized letter7
dated September 21, join in the call for the Secretary of State
to "take a leadership role in encouraging FDA to reduce amalgam
use."
FDA's Stance Sends Embarrassing Message to Treaty Partners
Aside from the health risks of having mercury implanted in
your teeth next to your brain, dental amalgams are also a
significant environmental polluter. As noted by The
Sacramento Bee:8
"A 2013 report by the US Geological Survey said
dental mercury fillings now account for 35 percent to 57
percent of the nation's end-use mercury products. One study
found an estimated 28.5 tons of mercury dental waste had
been released to the environment...
The Minamata treaty aims to protect people around the
world by limiting environmental emissions and releases of
mercury into the environment... Its name stems from a
disaster in the 1950s when more than 1,700 people who lived
near Japan's Minamata Bay died after eating fish
contaminated by mercury-laden wastewater from a chemical
plant."
The US was the first of 128 countries to sign the mercury
treaty two years ago. Yet embarrassingly, the FDA has not taken
a single step toward fulfilling its international promise to
phase down amalgam use. Eight other nations have already cut
their use of dental mercury by 95 percent. This includes Norway,
Sweden, Japan, the Netherlands, Finland, Estonia, Italy and
Denmark.
According to Michael Bender, director of the Mercury Policy
Project: "Unless FDA's policies toward amalgam phase down
are changed, it may undermine mercury reduction efforts in the
US. It also could send the wrong message to other Parties to the
Minamata Convention."
Congratulations! Your Support Is Paying Off!
Over the last several years, I've repeatedly called on your
help to support the work Charlie Brown and Consumers for Dental
Choice are doing, and you have consistently delivered — with
financial donations and signatures on various petitions. The
latest media focus on this issue could not have come without
your dedicated support and participation. More often than not,
grassroots efforts such as these are tough going. But it is
working, and you can pat yourselves on the back for making
it happen.
As noted by Charlie in a recent newsletter update:
"The letter from these environmental superstars is a
culmination of years of our bridge-building with
environmental groups. In the movement to abolish mercury
fillings, we hold many cards: amalgam can harm consumers'
health, risk dental professionals' health, pollute the
environment, violate consumer rights, and inflict social
injustice. We will play each and every card needed to win...
and we are going to win."
Three Ways You Can Help Make Mercury-Free Dentistry a Reality
for All
There are amalgam phase-out campaigns in Europe, Asia,
Africa, Latin America, and the US, where efforts are now focused
on pressuring the FDA to uphold the promise made by the nation
when it signed the Minamata treaty on mercury pollution. It's
quite simple. The US made a promise to the international
community to immediately begin reducing the use of amalgam, and
the FDA is in direct violation of this promise.
It's an embarrassment to the White House and the entire
country that the FDA is refusing to take the most basic of steps
toward the phase-down of mercury fillings, which is to
inform consumers that amalgam is made with mercury,
allowing them to make an informed choice. Consumers for Dental
Choice has proven itself as an effective and efficient NGO, and
your support will allow them to continue working on our behalf
to protect human health, especially minorities and the
underprivileged, and the health of the environment. There are
three ways you can help Consumer's for Dental Choice succeed:
- Use only mercury-free dentists. If your
dentist still offers amalgam as a choice, switch to one who
will not put mercury in anyone's mouth. Also be
sure to let your dentist know why you're leaving.
- Join Consumers for Dental Choice's newsletter
list on
ToxicTeeth.org, or
Mercury-Free.org, or write to Charlie at
Charlie@ToxicTeeth.org.
- Make a donation to Consumers for Dental Choice.
What's Lurking in Your Silver Fillings?
It's estimated that 75 percent of Americans are ignorant about
that fact that amalgam fillings are actually 50 percent mercury, and
this is no accident. The American Dental Association (ADA)
popularized the deceptive term "silver fillings" so consumers would
think amalgam is made mainly of silver when actually it has twice as
much mercury as silver.
Mercury is an incredibly potent neurotoxin; it doesn't take much
to cause serious damage because it's an absolute poison. If you were
to take the amount of mercury in a typical thermometer and put it in
a small lake, that lake would be closed down due to environmental
hazards.
Yet, amounts much higher than that are readily put into your
mouth if you receive a "silver" amalgam dental filling, as the
majority of material in the filling is actually mercury.
Download your free copy of Measurably Misleading and learn how
the FDA and dental industry are misleading consumers and why that's
bad for American families and our planet.
Help Support Mercury-Free Dentistry
We believe in inspiring progress -- and nowhere is the progress
more evident than the work of Consumers for Dental Choice and its
Campaign for Mercury-Free Dentistry. So consider donating your funds
where you know it will get results.
Consumers for Dental Choice take the Holistic Approach to
Advocacy. You wouldn't go to traditional dentist who uses mercury
amalgam fillings. So why would you go to a traditional activist to
fight for mercury-free dentistry? That's why so many people,
including myself, support Consumers for Dental Choice's holistic
approach to advocacy.
Resources to Help You Find a Biological Dentist
The following organizations can help you to find a mercury-free,
biological dentist:
Let's Help Consumers for Dental Choice Get The Funding They Deserve
Consumers for Dental Choice and its leader Charlie Brown continue
their full-court-press campaign to bring mercury-free dentistry to
the U.S. and worldwide. If you wish to stay informed, I
encourage you to follow them on
Facebook; and if you wish to stay informed by receiving their
announcements, you can sign up by
CLICKING HERE
You can help stop dental mercury today! Please consider a
donating to Consumers for Dental Choice, a non-profit organization
dedicated to advocating mercury-free dentistry.
© Copyright 1997-2015 Dr. Joseph Mercola. All Rights Reserved.
http://articles.mercola.com/sites/articles/archive/2015/10/06/fda-slow-reaction-on-mercury.aspx
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