ADA Files Petition with U.S. Food and Drug Administration Regarding Direct to Consumer Orthodontic Aligners
Treating patients, improving health and making a difference in patients’ lives is what drove many of us to become part of this amazing profession. I believe, and I’m sure you do, too, that making a difference also means standing up for patients and the profession through advocacy.
On Feb. 25, a group of ADA leaders, including myself and key ADA staff met with senior officials at the U.S. Food and Drug Administration (FDA) in Washington, D.C., to discuss direct to consumer orthodontic aligners.
Our 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 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.
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.
In lieu of having dentists perform patient exams meeting the applicable standard of care as the basis for prescribing orthodontic treatment, SDC tries to protect its own commercial interests by requiring customers to self-certify their dental condition and then hold SDC harmless from any negative consequences suffered as a result of SDC’s aligner “treatment therapy.”
The process SDC currently uses does not take into account any underlying, undiagnosed dental disease. Thus, the patient misses the opportunity to have their oral health assessed prior to beginning treatment. Tooth movement in the absence of good oral health has the potential to exacerbate oral disease and cause the patient additional harm.
Please know that dentists and the public can use the FDA’s MedWatch voluntary reporting form to inform the FDA about problems patients encounter with direct to consumer products, such as aligners, partial dentures and snoring appliances. More general information about the FDA medical device reporting program can be found on the FDA's website.
If you are asked about the issue of “DIY dentistry,” the ADA offers these talking points that you can share with your patients:
• The American Dental Association and member dentists across the country are dedicated to the health and safety of the patients they serve.
• ADA policies oppose Do-It-Yourself Teeth Straightening and Direct to Consumer Dental Laboratory Services because dentists are concerned about the potential for irreversible harm to patients.
• For example, orthodontic treatment, if not done correctly, could lead to potential bone loss and receding gums, changed bites, and other issues.
• The ADA believes that for the health and well-being of the public, patient supervision by a licensed dentist is necessary for all phases of treatment.
• You can find more information on MouthHealthy.org, the ADA’s website for the public at MouthHealthy.org/DIYdentistry.
Jeffrey M. Cole, D.D.S., M.B.A.
American Dental Association