The ADA has sent a complaint letter to the Federal Trade Commission (FTC) Bureau of Consumer Protection raising concerns over aspects of SmileDirectClub’s marketing and direct-to-consumer sales of plastic teeth aligners.
The letter was sent about two months after the ADA filed a citizen’s petition with the Food and Drug Administration (FDA) in April stating that SmileDirectClub is placing the public at risk by knowingly evading the FDA’s “by prescription only” restriction on teeth aligning materials.
The FDA has designated plastic teeth aligners a Class II medical device that requires a prescription.
According to the ADA, SmileDirectClub requires customers to self-report their dental condition in lieu of having dentists perform patient exams that meet the applicable standard of care as the basis for prescribing orthodontic treatment.
The ADA argues that self-reporting does not meet the standard of care because it does not satisfy a dentist’s required professional due diligence. Also, the ADA says, lay people are not expected to be familiar with specialized technical or medical vocabularies.
Furthermore, the ADA says that SmileDirectClub and the small number of “SDC-affiliated” dentists have no way of knowing whether what the lay consumer attests to is accurate, informed, or true in any respect.
“Moving teeth without knowing all aspects of a patient’s oral condition has the potential to cause the patient harm,” said ADA president Jeffrey M. Cole, DDS, MBA. “Orthodontic treatment, if not done correctly, could lead to potential bone loss, lost teeth, receding gums, bit problems, jaw pain, and other issues.”
SmileDirectClub treatment begins when patients visit a SmileShop and get a 3-D scan of their mouth. Or, patients use the at-home impression kit to create an impression of their mouth and send it to the company, which then builds the scan. A duly licensed dentist or orthodontist oversees each smile plan and checks in with the patient remotely every 90 days.
Also, SmileDirectClub requires patients to hold the company harmless from any negative consequences.
In its letter to the FTC, the ADA cited specific SmileDirectClub practices that it believes to be deceptive under section 5 of the Federal Trade Commission Act, including:
- Informing customers they have recourse against SmileDirectClub via arbitration when, in the same document, SmileDirectClub hides a “small print” provision obligating customers to waive any and all rights they “or any third party” may have against the company.
- Encouraging consumers to become customers by telling them individually and directly that SmileDirectClub aligners will correct their overbite, underbite, and crossbite conditions or their “extreme” malocclusion, but when customers complain, the company invokes its other documents stating its aligners cannot treat bite conditions at all and can only treat mild to moderate teeth misalignment, not “extreme” misalignment.
- Claiming that customers receive the same level of dental or orthodontic care as actual dental patients when the company and its affiliated dentists provide virtually no care and, contrary to its claims, does not use teledentistry.
“The ADA considers it our duty on behalf of the public to make the relevant regulatory agencies aware of what is going on so they can consider whatever actions they deem appropriate,” Cole said.