Devices

Ban Mercury Amalgam Fillings: Petition

Three advocacy groups — Consumers for Dental Choice, Alliance of Nurses for Healthy Environments, and Mercury Policy Project — are petitioning FDA to ban mercury amalgam dental fillings. The 4/16 petition specifically asks the agency to:

ban dental amalgam;
ban the use of dental amalgam at least in high-risk populations, including children, pregnant women, women who are planning to become pregnant, nursing women, people with neurological disease, people with impaired kidney function, and people with sensitivity to mercury or other amalgam components; and
take other measures to protect the public, especially children, from amalgam’s mercury.

In stating its grounds, the petition makes these points:

amalgam presents a substantial deception;
amalgam presents an unreasonable and substantial risk of illness or injury;
labeling cannot eliminate amalgam’s risks; and
banning amalgam presents no risks, only benefits.

In 2022, FDA denied most parts of four Consumers for Dental Choice petitions that asked for additional Warnings and labeling requirements for amalgam use in dentistry. The denial letter said two of the petitions asked FDA to warn against dental amalgam use in children, pregnant women, and other sensitive populations, and to stop amalgam use in children under age 15, pregnant women, and breastfeeding mothers.

The letter said FDA partially granted the petition to the extent of a 9/2020 safety communication to dentists, dental associations, parents, and dental consumers about potential risks of dental amalgam use by vulnerable populations and the use of non-mercury restorations when possible and appropriate.

“In several respects,” FDA said in 2020, “the petitions fail to provide information that would cause FDA to determine that additional actions, such as the proposed public campaign to stop amalgam use in dentistry, are necessary or appropriate. We are therefore denying your request for additional Warnings and a public campaign to stop amalgam use or otherwise to contraindicate amalgam use in vulnerable populations.”

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