Both the ADA and SmileDirectClub in the past week issued competing statements regarding government enforcement actions -- or the lack of same -- that give each group's own spin on the dispute. Dental organizations such as the ADA and state dental boards have waged an ongoing battle with SmileDirectClub, charging that the company should be regulated under state practice-of-dentistry rules; the company has countered with antitrust allegations, including actions in Georgia and Alabama.
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. The ADA claims that SmileDirectClub is circumventing FDA rules by selling its aligners directly to consumers rather than through prescriptions issued by dentists.
The second is a complaint filed with the U.S. Federal Trade Commission (FTC) regarding SmileDirectClub business practices that the ADA claims are "deceptive." The ADA particularly objects to the fact that SmileDirectClub customers self-report their dental conditions -- and patient self-reporting does not meet the standard of care, according to the association.
The dispute spilled into the open on October 4, when SmileDirectClub issued a statement on "organized dentistry's anticompetitive legal actions." The company 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."
SmileDirectClub took 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. The company 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 and that 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," noted ADA President Chad Gehani, DDS. In fact, the comment period on the petition is open through October 22.
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.
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