Update on FDA Recommendations
Today (9/24), the Food and Drug Administration (FDA) released new messaging about dental amalgam for some groups of patients. TDA agrees with the ADA's statement to the FDA that "Dental amalgam is one of the safest and most affordable and durable materials available."
ADA leadership has kept in communication with the FDA, and emphasize that dentists are still free to use amalgam for patients.
This is not a ban, nor a change in FDA’s position. The majority of evidence continues to suggest amalgams pose little to no risk for adults who do not have any allergies to the materials used. The FDA's recommendations only apply to certain vulnerable populations, due to insufficient data for some clinical situations.
The FDA's recommendations are the result of their November 2019 hearing on metal implants across a wide variety of healthcare fields, including orthopedics and gynecology as well as dentistry. Before last year's hearing, the ADA reaffirmed in written comments to the FDA what has been known for decades:
that "dental amalgam is one of the safest and most affordable and durable materials available." ADA also had 4 representatives at the hearing
, to present evidence from the dental profession.
Organized dentistry continues to advocate for dentists and patients by bringing evidence-based research to the forefront of any discussion.
For ADA’s background on the FDA’s hearing, and ADA’s comments and representation, please CLICK HERE
The FDA's updated messaging is available on fda.gov
. FDA recommends all patients discuss their health history and treatment options with their dentist. FDA’s patient brochure states, "Studies on people with dental amalgam do not show conclusive evidence that dental amalgam causes harmful health effects in the general population."