On July 11, the American Dental Association announced 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’s 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.
“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