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# FDA Asked for Dental Amalgam Patient Labeling
- URL: https://www.fdaweb.com/fda-asked-for-dental-amalgam-patient-labeling/
- Published: 2016-05-19T12:00:00.000Z
- Updated: 2026-09-14T21:03:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135721

The Campaign for Mercury Free Dentistry has petitioned FDA to amend its mercury amalgam rule to require patient labeling for dental amalgam. The [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-1303-0001&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) urges the agency to require manufacturers to distribute patient labeling containing information on **(1)** amalgam’s mercury content; **(2)** amalgam’s risks to children and fetuses; **(3)** the damage amalgam can do to tooth structure; **(4)** the damage caused by amalgam in the environment; and **(5)** the benefits of mercury-free fillings.

Such labeling is required, the petition says, by the Minamata Convention that was signed by the U.S. on 11/6/13\. That convention, according to the group, requires parties to “phase down the use of dental amalgam.”

“FDA concedes that giving patients labeling with ‘direct information that would include the presence of mercury in amalgam’ would result in ‘an expected reduction in mercury exposure,’ the petition says. “Yet FDA refuses to take this effective amalgam phase-down measure.”

The document also says that labeling is needed to conform to new international guidance from the United Nations Environment Program. And it says that it is recommended by some FDA advisory panel members and is needed to comply with an agency guidance on medical device patient labeling.