FDA Denies Most Parts of 4 Dental Amalgam Petitions
FDA has granted in part and denied in part four Consumers for Dental Choice petitions submitted from 2015 to 2017 asking for additional warnings and labeling requirements for amalgam use in dentistry. The denial letter says 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 petitions called on the agency to (1) issue a safety communication to dentists, parents, and dental consumers; (2) require manufacturers to distribute patient labeling that includes the warnings; and (3) develop and implement a public relations campaign against amalgam use in the vulnerable populations cited. Another of the petitions asked FDA to implement a media education campaign to promote mercury-free dental filling materials, and the fourth asked the agency to amend its regulations to require manufacturers to distribute patient labeling that specifies amalgam’s mercury content, risks, damage to tooth structure, damage to the environment, and the benefits of mercury-free fillings. Finally, the organization asked that FDA amend the dental amalgam regulation and revoke the sections of the mercury amalgam rule promoting amalgam use or opposing the phase-down of amalgam use.
“As reasons for FDA to take these requested actions,” the letter says, “the petitions cite U.S. government acceptance of the U.N. Minamata Convention on Mercury, the actions of the European Union and other countries, European Commission and World Health Organization findings, FDA’s 2006 and 2010 advisory committee panel meetings, and various scientific studies, among other sources.”
The letter says FDA partially granted the petition to the extent of a safety communication it issued in 9/2020 providing information to dentists, dental associations, parents, and dental consumers regarding potential risks of dental amalgam use by vulnerable populations and use of non-mercury restorations when possible and appropriate. “In several respects,” it continues, “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 requests for additional warnings and a public campaign to stop amalgam use or otherwise to contraindicate amalgam use in vulnerable populations.”