Do it yourself orthodontics
ADA Raises Concerns About SmileDirect Club With FTC, FDA
The ADA News (7/12, Solana) reported that on June 27, the ADA “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.” In addition, about two months ago the ADA “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.” ADA President Jeffrey M. Cole said, “The ADA took these actions out of concern for patient safety and to enable consumers to take action when negative treatment outcomes occur.” Dr. Cole noted that “orthodontic treatment, if not done properly, could lead to potential bone loss, lost teeth, receding gums, bite problems, jaw pain and other issues.” He added, “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.
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.