Dantal amalgam dangerous

Dear Consumer,

Dr. Sharfstein asked me to respond to your recent email message about dental amalgam. 

Under its recent final rule on dental amalgam, the FDA has – for the first time – put in place specific special controls for the labeling and use of dental amalgam and dental mercury. 

The final regulation requires that the labeling for dental amalgam include clear warnings that dental amalgam contains mercury, and that it may be harmful if vapors are inhaled.  Labeling must also include a statement of the device’s mercury content by weight.

The final rule also requires that the labeling for dental amalgam include a statement for dental professionals that explicitly explains the current state of scientific knowledge related to dental amalgam and its potential health risks – including potential risks to developing fetuses and young children.  This statement appears in full at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/ucm171120.htm.

There is currently an email message circulating about dental amalgam that contains several errors.  You may have received this email or other related statements.

The email implies that the FDA had concluded under the previous administration that dental amalgam is harmful to fetuses and developing children.  This is untrue.

The FDA’s dental amalgam website formerly included the following statement: “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.  When amalgam fillings are placed in teeth or removed from teeth, they release mercury vapor.  Mercury vapor is also released during chewing.  FDA’s rulemaking (described in question 7) will examine evidence concerning whether release of mercury vapor can cause health problems, including neurological disorders, in children and fetuses.”

This statement did not make the conclusion that the levels of mercury vapor exposure associated with dental amalgam cause harm to fetuses or young children.  Instead, it made clear that the FDA, in developing its regulations on dental amalgam, would evaluate scientific evidence on the potential risks to these populations.  The FDA has reviewed the available evidence, and its analysis and conclusions are described on the FDA’s new dental amalgam consumer website (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/default.htm).

Additionally, the email implies that the safety standard that FDA has applied to dental amalgam is less rigorous than the standard applied to certain mercury-containing veterinary products.  This is also untrue. 

The FDA applies rigorous safety standards for all mercury-containing products.  If the best available scientific evidence leads to a conclusion that a particular product contains an unsafe level of mercury – as in the case of topical products that had previously been used to treat infections – then the FDA will not support its use.  However, the FDA permits the use of mercury as a component of both animal and human medical products when the use is considered safe.  For example, mercury-containing preservatives are used in some human and veterinary vaccines. 

The email also questions Commissioner Hamburg’s involvement in the dental amalgam rule-making process.  Commissioner Hamburg was not involved in the FDA’s decision-making on dental amalgam and has recused herself from this topic.

Thank you again for expressing your concerns.  You should also be aware that there are formal procedures that you can use to ask the agency to reevaluate its decisions.  These procedures are set out in 21 C.F.R. Part 10 (available online at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=10).  If you believe you have additional information that would justify such a request, please feel free to follow these procedures.


Patricia M. Kuntze

Senior Advisor for Consumer Affairs

Food and Drug Administration