Dispute Between the Dental Organizations and SmileDirectClub
There is an ongoing Dispute Between the Dental Organizations and SmileDirectClub.
SmileDirectClub, Inc. is the industry pioneer as the first direct-to-consumer MedTech platform for transforming smiles. Through our cutting-edge teledentistry technology and vertically integrated model.
SmileDirectClub’s mission is to unleash the power of people’s smiles to empower them to positively impact their place in the world. Alex Fenkell and Jordan Katzman in partnership with Camelot Venture Group are the founders of SmileDirectClub.
Communication with licensed orthodontic professionals and other SmileDirectClub staff takes place virtually. Impression kits are sent to customers after which teeth molds are reviewed by dentists or orthodontists who oversee the treatment process. The company reportedly works with 225 licensed professionals.
Legal Actions filed by the Industry Trade Organizations
Recently, there have been media statements by dental trade organizations. Allegations in a class-action lawsuit filed in Nashville federal court that purports to question the safety and legitimacy of SmileDirectClub’s pioneering teledentistry platform.
SmileDirectClub denies the allegations made in the class-action lawsuit and by these dental trade organizations and their members. The American Dental Association (ADA) and SmileDirectClub have issued dueling press statements in their ongoing dispute over government regulation of SmileDirectClub‘s clear-aligner business.
See also: How to Prevent Dental Practice Audits
The dispute spilled into the open on October 4, 2019
Both the ADA and SmileDirectClub issued competing statements regarding government enforcement actions that give each group’s own spin on the dispute in the past week,
Dental organizations such as the ADA and state dental boards have waged an ongoing battle with SmileDirectClub. They are charging the company to be regulated under state practice-of-dentistry rules. The company has countered with antitrust allegations, including actions in Georgia and Alabama.
The ADA claims that SmileDirectClub is circumventing FDA rules. They are selling their aligners directly to consumers rather than through prescriptions issued by dentists. ADA currently has initiated several regulatory actions aimed at SmileDirectClub.
One is a citizen’s petition filed with the U.S. Food and Drug Administration (FDA) in April 2019 that asked the agency to issue an injunction prohibiting SmileDirectClub from directly selling its aligners to the public. A complaint filed with the U.S. Federal Trade Commission (FTC) regarding SmileDirectClub business practices that the ADA claims are “deceptive” is the second one.
According to ADA, Patient Self-Reporting does not Meet the Standard of Care
The ADA particularly objects to the fact that SmileDirectClub customers self-report their dental conditions. SmileDirectClub claimed that the recent actions against it were “The latest in a stream of unevidenced and misleading attempts by dental trade organizations, certain of their members and others motivated to thwart legitimate competition.”
The company took a particular issue with the ADA, accusing the group of orchestrating a “misinformation campaign” that claimed that the company did not have 510(k) clearance for its clear aligners. They also claimed that the FDA had declined the ADA’s request in the citizen’s petition for an injunction to stop its sales of clear aligners.
Not so fast, the ADA noted in its own statement on October 9. The group claimed that its citizen’s petition with the FDA was still under review. The SmileDirectClub was mischaracterizing a May 30 letter the agency sent in response to the petition.
All substantive issues raised by the ADA’s citizen petition remain fully before the FDA at this time.ADA President Chad Gehani, DDS.
Dr. Gehani noted that the FDA designates plastic teeth aligners as a class II medical device requiring a prescription. “The ADA believes the company is placing the public at risk by knowingly evading the FDA’s “by prescription only” restriction,” he stated.
The ADA noted that the FDA’s refusal to issue the injunction was taken because the FDA does not initiate enforcement actions on behalf of petitioners. “All substantive issues raised by the ADA’s citizen petition remain fully before the FDA at this time,” Dr. Gehani stated.
“There is no scientific or medical justification to substantiate the false claims made about the safety, effectiveness, or standard of doctor care using our teledentistry model and the state-licensed doctors in our affiliated network. We will vigorously defend ourselves and our business model to continue to pursue our company’s mission to increase access to affordable, safe, and convenient teeth straightening solutions.”– SmileDirectClub
This will likely be a long battle. We should follow the advice of our leaders in organized dentistry and begin sharing our patients’ challenges with unsupervised orthodontics. We are the defenders of our patients’ oral health and it’s time to act. Hopefully, this dispute between the dental organizations and SmileDirectClub will be fixed soon.
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