ADA sets record straight on status of petition to FDA regarding SmileDirectClub
October 10, 2019
The ADA’s pending citizen petition submitted to the U.S. Food and Drug Administration about SmileDirectClub’s marketing and direct-to-consumer sales of plastic teeth aligners is very much active, contrary to inaccurate public statements from SmileDirectClub stating otherwise, according to a statement Oct. 9 from Association President Chad P. Gehani.
SmileDirectClub inaccurately stated in an Oct. 4 news release that the ADA’s petition has been “shut down” and “dismissed.” The news release was apparently based on a May 30 letter from the FDA to the ADA, which stated, “We appreciate the information [the ADA] provided. Such information is often helpful for us to identify problems with marketed products and possible violations of the laws and regulations that we enforce. We take complaints seriously and we will evaluate this matter to determine what follow-up action is appropriate.”
The letter further explains that the FDA does not initiate enforcement actions on behalf of petitioners. Instead, the FDA reviews the submitted evidence and decides for itself what action to take. All substantive issues raised by the ADA’s citizen petition remain fully before the FDA at this time.
The FDA’s MedWatch voluntary reporting form may be used by both consumers and health care professionals to report poor clinical outcomes associated with medical devices, including plastic teeth aligners. The comment period for the public to address the petition and for the ADA to supplement the petition is open until Oct. 22 at 11:59 pm.
People can also provide comments on the petition at https://www.regulations.gov/document?D=FDA-2019-P-2038-0001.
The ADA filed its citizen’s petition with the FDA April 25, 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. On June 27, the ADA sent a letter to the Federal Trade Commission’s Bureau of Consumer Protection, raising the same concerns.
“The ADA submitted its citizen petition and a complaint letter to the Federal Trade Commission’s Bureau of Consumer Protection out of concern for public safety and customer recourse in the event of negative outcomes from SmileDirectClub’s orthodontic ‘treatment therapy,’” Dr. Gehani said. “Plastic teeth aligners are designated by the FDA as a Class II medical device requiring a prescription.”
The FTC also offers consumers an online form to report complaints about unfair and deceptive business practices on its website.
In lieu of having dentists review patient dental records or perform any sort of patient exam (whether using teledentistry or otherwise) before prescribing orthodontic treatment, SmileDirectClub instead requires customers to self-report their dental condition. As the ADA explains in its citizen petition, customer self-reporting does not meet the applicable standard of care because it does not satisfy a dentist’s requisite professional due diligence.
“Put simply, SmileDirectClub and the small number of SmileDirectClub-affiliated dentists have no way of knowing whether a lay consumer’s self-reported dental condition is accurate, informed, or true in any respect,” Dr. Gehani said. “Moving teeth without knowing all aspects of a patient’s oral condition has the potential to cause bone loss, lost teeth, receding gums, bite problems, jaw pain and other issues. Despite these potentially serious outcomes, SmileDirectClub requires its customers to hold the company harmless from any negative consequences.”
In addition to the public health concerns, the ADA’s letter to the FTC cited various SmileDirectClub practices the ADA believes to be deceptive under section 5 of the Federal Trade Commission Act, including:
• Informing purchasers they have recourse against SmileDirectClub via arbitration, when the same document includes a “small print” provision obligating the customer to waive any and all rights the customer “or any third party” may have against SmileDirectClub.
• Soliciting customers by claiming that SmileDirectClub aligners will correct their overbite, underbite, and crossbite conditions, or their “extreme” malocclusion. But after customers complain about poor clinical outcomes, SmileDirectClub invokes other documents stating that its aligners cannot treat bite conditions at all and can only treat mild to moderate teeth misalignment, not “extreme” misalignment.
• Claiming that SmileDirectClub customers receive the same level of dental/orthodontic care as actual dental patients, when in fact SmileDirectClub and its affiliated dentists provide virtually no care and, contrary to its claims, SmileDirectClub does not use teledentistry.
“The ADA considers it our public duty to make the relevant regulatory agencies aware of these facts, so those agencies can be fully informed and consider whatever actions they deem appropriate,” Dr. Gehani said.