450 days and counting….When’s FDA going to act on dental mercury?
said Jeff Shuren, Director of the Center for Devices and Radiological
Health at the U.S. Food and Drug Administration (FDA), on September 22,
2011. He is telling the public what FDA plans to do about dental
silence. It’s been 450 days since FDA’s self-imposed deadline….and no
announcement on dental amalgam. 450 days….and not a single word from
is beyond a doubt a hazard in our environment; that is why so many
government officials on every continent are dedicated to phasing down –
and ultimately phasing out – its use. But FDA failed to consider the
environmental health threat posed by this mercury product in its 2009
dental amalgam rule.
address the problem of amalgam use in children – even though its own
hand-picked advisory panel on dental amalgam raised this concern again
and again during its 2010 meeting. The scientists on that panel told
FDA there is “no place for mercury in children”…. recommended that in
“children less than 6 years of age, I would restrict it significantly”….
insisted that amalgam did not belong in “pregnant women and definitely
not in those below 6 years of age”…. and asked FDA, “why put amalgams in
children if we know they’re going to live with that for the rest of
their lives? And we don’t know what that’s going to do.” In fact, not a
single scientist on FDA’s advisory panel agreed with FDA’s 2009 rule
that promoted unrestricted amalgam use in children and pregnant women.
Shuren himself has acknowledged the FDA panel’s conclusion: “Now, the
panel did …point out that there may be certain populations who are more
sensitive to dental amalgam, like young children and pregnant women.” So why doesn’t FDA protect those young children and pregnant women from this unnecessary source of mercury exposure?
- Canada: Since
1996, Health Canada has recommended against placing amalgam in children
and pregnant women. Additionally, Health Canada says “Amalgam should
not be placed in patients with impaired kidney function.”
Even before phasing out amalgam use altogether, the Swedish government
took steps to protect children: “From 1 June 2009, it will be prohibited
to use dental amalgam in ordinary dental care in Sweden and there will
be a total ban to use it in the dental care children and youth.”
- United Kingdom:
In 1998, the British government’s Department of Health sent a letter to
dentists explaining it is prudent to avoid the placement of amalgam
- Australia: Since
2002, the Australian government’s National Health and Medical Research
Council has distributed a consumer brochure advising that amalgam should
be avoided in pregnant women, breastfeeding mothers, children, and
people with kidney disease.
- Denmark: Denmark’s government does not allow amalgam to be used in children’s baby teeth.
the U.S. is far behind in protecting children from dental mercury – one
of the largest sources of mercury exposure for the general public (even
before exposure to environmental dental mercury is taken into account).
What can you do?
- EMAIL FDA Director Shuren at Jeff.Shuren@fda.hhs.gov or
- CALL him at 301-796-5900 or
- FAX him at 301-847-8510 or
a letter to Director Jeff Shuren, CDRH, Building WO66, Room 5442, U.S.
Food and Drug Admin., 10903 New Hampshire Ave. Silver Spring, MD 20993
FDA panel on dental amalgam that met in 2010 recommended against using
dental amalgam in young children and pregnant women. What are you doing
to protect young children and pregnant women from dental amalgam?
nations like Canada, Australia, the United Kingdom, Sweden, and Denmark
have taken steps to protect children and pregnant women from dental
amalgam. Why is the U.S. so far behind other nations?
said FDA would make an announcement on dental amalgam by December 31,
2011. We have waited patiently for 450 days, but it is now 2013. When
is FDA going to start protecting our children from dental mercury?
With your help, we can show our government that the public will not
rest until FDA is at least protecting our children from dental mercury!
3 April 2013
Charles G. Brown
National Counsel, Consumers for Dental Choice
President, World Alliance for Mercury-Free Dentistry
316 F St. NE, Suite 210 Washington, DC 20002 USA
Phone: 202-544-6333 Fax: 202-544-6331
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