June 27, 2019
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documents that state its aligners cannot treat bite conditions at all and can only treat mild
to moderate teeth misalignment, not “extreme” misalignment; and,
3. Claiming that SDC customers receive the same level of dental/orthodontic care as actual
dental patients when actually SDC and its “affiliated dentists” provide virtually no care
and, contrary to its prominent and repeated claims, SDC does not use teledentistry.
I. This Complaint Addresses Issues Different from those
Raised in the ADA’s Pending FDA Citizen Petition
On May 1, 2019 the FDA posted the ADA’s citizen petition (Docket ID: FDA-2019-P-2038),
which focuses on SDC’s failure to comply with the FDA’s Class II Device “prescription only”
requirement applicable to plastic teeth aligners and on the clinical dangers that conduct poses to
public health and safety. Although the present complaint recites some of the same facts as the
citizen petition, and even uses some of the same language and exhibits, the ADA is fully aware
of the respective agencies’ differing areas of concentration and jurisdiction.
The ADA is not seeking duplicative review here, but in compiling its FDA petition the ADA
identified a number of substantive deceptive acts that SDC depends on to generate sales. SDC’s
disregard for consumer health and safety, on the one hand, and its persistent deceptive acts to
drive high volume sales, on the other, together form the foundation of the company’s business
model. SDC’s business approach depends on ignoring important treatment standards while
attempting to persuade customers either that it does observe those standards or that failing to do
so is unimportant.
II. Who is SmileDirectClub, LLC?
Although SDC has variously described itself as a mere “re-packager,” or “contract
manufacturer,” of Orthodontic Plastic Brackets (in FDA filings), and in court papers as “a dental
support organization [DSO] that provides administrative non-clinical support to dentists and
orthodontists…”
2
, in reality SDC is very aggressively involved at every level in the manufacture,
2
Scott D. Galkin, D.M.D. and New Jersey Dental Association v. SmileDirectClub, LLC, Danny Leeds, D.D.S.,
Robert M. DeRosso, D.M.D. and Isaac V. Perle, D.M.D., MID-C-19-19, Brief in Support of Defendant’s Motion to
Dismiss, p. 3.