ADA Files Petition with FDA Regarding Direct to Consumer Orthodontic Aligners
On February 25, a group of ADA leaders met with senior officials at the U.S. Food and Drug Administration (FDA) in Washington, D.C., to discuss direct to consumer orthodontic aligners.
Their chief concerns centered on patient safety; transparency in diagnosis and treatment planning; and patient recourse when the results are not positive.
As a result of this meeting, ADA leaders determined a citizen petition should be filed.
The basis for the ADA’s citizen petition to the FDA is straightforward: SmileDirectClub, LLC, (SDC) is placing the public at risk by knowingly evading the “by prescription only” restriction that the FDA has placed on plastic teeth aligners and on dental impression material. For all intents and purposes, SDC sells its plastic teeth aligner and dental impression material products to consumers over-the-counter.
The petition was filed on April 25, and we will share a link with you once it is posted on the FDA’s website. ADA science and government affairs staff will continue to follow up on the status of the petition with key contacts at the FDA.