ADA files complaint with FTC, FDA against SmileDirect Club

Dr. Jeffrey M. Cole, ADA president

The Association announced July 11 it sent a complaint letter to the Federal Trade Commission’s Bureau of Consumer Protection, raising concerns over aspects of SmileDirect Club’s marketing and direct-to-consumer sales of plastic teeth aligners.

The letter, sent on June 27, comes about two months after the Association filed a citizen petition with the U.S. Food and Drug Administration, stating that SmileDirect Club 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.

In an email to ADA members, Dr. Cole outlined practices of SmileDirect Club, L.L.C. that the Association believes to be deceptive. These include:

  • Informing purchasers they have recourse against SmileDirect Club via arbitration when in the same document, SmileDirect Club hides a “small print” provision obligating the customer to waive any and all rights the customer “or any third party” may have against SmileDirect Club.
  • Encouraging consumers to become customers by telling them individually and directly that SmileDirect Club 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 citizen petition filed with the FDA, the Association states that SmileDirect Club is knowingly evading the “by prescription only” restriction that the FDA placed on plastic teeth aligners and on dental impression material.

In lieu of having dentists perform patient exams meeting the applicable standard of care as the basis of prescribing orthodontic treatment, SmileDirect Club requires customers to self-report their dental condition, according to the Association. The ADA argues in its petition that self-reporting does not meet the standard care of care because it “does not 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.”

In both communications the ADA sent to the FDA and FTC, the Association also underscored that SmileDirect Club requires customers to hold the company harmless from any negative consequences.

“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,” Dr. Cole said.

For more information about direct to consumer dentistry, visit the ADA’s consumer website MouthHealthy.org/DIYdentistry.

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/safety/medical-product-safety-information/forms-reporting-fda.

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