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For the American Dental Association, the work of patient advocacy extends beyond the clinic. Last spring with patient health in mind, we filed a citizen petition with the U.S. Food and Drug Administration (FDA) about SmileDirectClub, LLC’s direct-to-consumer plastic teeth aligner business.
As you may know, SmileDirectClub’s orthodontic “treatment therapy” model requires customers to self-report their dental condition without a dentist’s review of their records or an examination. It is our belief that this practice does not meet the applicable standard of care, and it evades the FDA’s designation of plastic aligners as a Class II medical device requiring a prescription. SmileDirectClub customers also waive any right to recourse in the event of a negative outcome.
Despite the inaccurate statements made in an Oct.4 news release issued by SmileDirectClub, the FDA has not rejected or dismissed any substantive aspect of the ADA’s petition. The petition has not been “shut down,” and these misstatements may keep customers who have had any problems in connection to a SmileDirectClub aligner from reporting experiences to the FDA.
As advocates for patient safety, the ADA considered it a public duty to bring our concerns before the relevant regulatory agencies. In a May 30 letter in response to the ADA’s petition, the FDA noted the following: “We take complaints seriously and we will evaluate this matter to determine what follow-up action is appropriate.”
All substantive issues raised by the ADA’s citizen petition remain fully before the FDA at this time. The comment period of the public to address the petition is open until Oct. 22 at 11:59 p.m.
The FDA’s MedWatch voluntary reporting form may be used by both consumers and health care professionals to report poor clinical outcomes associated with medical devices, including plastic teeth aligners. The Federal Trade Commission also offers consumers an online form to report complaints about unfair and deceptive business practices on its website.
We will continue to keep you informed of any developments.
Thank you,
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Chad Gehani, DDS
President, American Dental Association
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