SmileDirectClub under fire for flouting federal regulations
Thursday, August 08, 2019
You may have seen ads for SmileDirectClub, a direct-to-consumer business model that sells plastic aligners to members for straightening teeth. At first pass, it may seem like a good idea. Straighten your teeth without so much as one visit to the orthodontist?
But not everyone is a fan.
The American Dental Association recently sent a complaint letter to the Federal Trade Commission’s Bureau of Consumer Protection, citing concerns over aspects of SmileDirectClub’s marketing and direct-to-consumer sales of plastic teeth aligners.
The letter follows a citizen’s petition filed by the ADA with the U.S. Food and Drug Administration, stating that SmileDirectClub is placing the public at risk by knowingly evading the FDA’s "by prescription only" restriction the agency has placed on teeth aligning materials.
"The ADA took these actions out of concern for patient safety and to enable consumers to take action when negative treatment outcomes occur," said Dr. Jeffrey M. Cole, ADA president. Dr. Cole outlined practices of SmileDirectClub that the Association believes to be deceptive. These include:
- Informing purchasers they have recourse against SmileDirectClub via arbitration when, in the same document, SmileDirectClub hides a “small print” provision obligating the customer to waive any and all rights the customer "or any third party" may have against SmileDirectClub.
- 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. However, when customers complain, SDC invokes other SDC documents that state its aligners cannot treat bite conditions at all and can only treat mild to moderate teeth misalignment, not "extreme" misalignment.
- Claiming that SDC customers receive the same level of dental/orthodontic care as actual dental patients when actually SDC and its affiliated dentists provide virtually no care and, contrary to its claims, SDC does not use teledentistry.
In the initial citizen petition filed with the FDA, the Association states that SmileDirectClub is evading the "by prescription only" restriction that the FDA placed on plastic teeth aligners and on dental impression material.
The ADA argues that SmileDirectClub is cutting out the step of having dentists perform patient exams, meeting the applicable standard of care, as the basis of prescribing orthodontic treatment. Instead, SmileDirectClub requires customers to self-report their dental condition. The ADA argues that self-reporting doesn’t meet the standard of care because it doesn’t satisfy a dentist’s required professional due diligence.
"Moving teeth without knowing all aspects of a patient’s oral condition has the potential to cause the patient harm," Dr. Cole said. "Orthodontic treatment, if not done properly, could lead to potential bone loss, lost teeth, receding gums, bite problems, jaw pain and other issues. The ADA considers it our duty on behalf of the public to make the relevant regulatory agencies aware of what’s going on so they can consider whatever actions they deem appropriate.
For more information about direct-to-consumer dentistry, visit the ADA’s consumer website MouthHealthy.org/DIYdentistry. And to report poor clinical outcomes associated with medical devices, consumers and health care professionals may use the FDA’s MedWatch voluntary reporting form at FDA.gov.
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