Consumers and dentists call on FDA to keep its promise to act on amalgam

450 days and counting…
When’s FDA going to act on dental mercury?

“We will by the end of the year, we will make an announcement.”

So 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 amalgam.

December 31, 2011 rolled around…. and 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 FDA. 

As confirmed by the mercury treaty talks, dental amalgam 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.

Not only that, but FDA failed to 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.

Director 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?

As we learned from governments and dentists around the world while we were working on the mercury treaty, other nations are already protecting them. For example:

  • 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.”
  • Sweden:  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 during pregnancy.
  • 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.

 

So 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).

Now is the time to catch up with the rest of the world. Dr. Oz spoke out about mercury fillings last week – this week it's your turn!

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 
  • MAIL 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

Ask Dr. Shuren:

  1. The 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?
  2. Other 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? 
  3. You 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?

450 days of FDA silence is enough.  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!

Charlie Brown
3 April 2013

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