Nine members of the U.S. House of Representatives have called on the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission to investigate SmileDirectClub to ensure that the clear-aligner company is not misleading consumers and harming patients.
The congressmen, all of whom are Republicans and most are doctors and dentists, penned a letter, requesting that the two U.S. government agencies investigate SmileDirectClub's questionable advertising tactics, its approximately 1,800 complaints filed with the Better Business Bureau (BBB), and its 510(k) registration with the FDA. This type of registration is a premarket submission made to the FDA to show that a device, like a clear aligner, is as safe and effective as a legally marketed device and does not need approval before it is placed on the market.
"We would appreciate, to the extent possible, your commitment to undertake such reviews in a swift manner in order to protect the health and safety of both current and prospective SmileDirectClub customers," they wrote in the letter sent to the agencies on January 6.
The letter was authored by Rep. Brian Babin, DDS, of Texas; Rep. Paul Gosar, DDS, of Arizona; Rep. Mike Simpson, DMD, of Idaho; Rep. Anderson Drew Ferguson IV, DMD, of Georgia; Rep. Jeff Van Drew, DMD, of New Jersey; Rep. David Philip Roe, MD, of Tennessee; Rep. Andy Harris, MD, of Maryland; Rep. John Joyce, MD, of Pennsylvania; and Rep. Earl L. "Buddy" Carter, BS in pharmacy, of Georgia.
This development further stokes the flames between the blossoming industry and traditional orthodontics.
The letter was also written in support of the American Association of Orthodontists' stance that orthodontic treatment is a complex medical process and that it is in the "best, and safest, interest of the public to have that treatment conducted under the direct and ongoing supervision of a licensed orthodontist."
Furthermore, the congressmen noted in the letter that consumers had filed 1,350 complaints with the BBB about the doctor-directed provider of at-home clear aligners. Currently, SmileDirectClub has 1,770 complaints for such issues as ill-fitting aligners, poorly constructed aligners, long waits for refunds, and unresponsive and incompetent customer service.
Another reason to frown
In addition to a potential investigation, SmileDirectClub also faces some other potential legal losses.
The Dental Board of California is asking the U.S. District Court for the Central District of California to dismiss the lawsuit that SmileDirectClub and its chief clinical officer Jeffrey Sulitzer, DMD, filed against it in October 2019. Dr. Sulitzer and SmileDirectClub sued the dental board, alleging it intentionally harassed the direct-to-consumer clear-aligner company's clinics in a planned effort to curb its growth.
The dental board filed a motion in December 2019, asking a judge to toss out the case because the board was investigating the company and clinician and not harassing them. To support this claim, the board noted the investigation led to the board filing a formal complaint against Dr. Sulitzer in November 2019.
The board alleges that Dr. Sulitzer, who oversees SmileDirectClub's SmileShops in California, violated the state's dental laws, including the use of fraud in the procurement of fictitious name and additional office permits, use of advertisement tending to deceive or mislead the public, treatment of patients not of record, and aiding and abetting the unlicensed practice of dentistry.
California has been especially tough on the direct-to-consumer orthodontics model. In September, California became the first state in the U.S. to pass a teledentistry law requiring x-rays and other steps be taken before patients can undergo treatment from providers such as SmileDirectClub.
A strong start in the new year
Despite this news, SmileDirectClub has had an otherwise promising start to 2020.
On January 13, the company scored a legal victory with the Superior Court of New Jersey finding that it did not engage in the "corporate practice of dentistry" and that the New Jersey Dental Association's claim that it illegally practiced dentistry in the state had no merit.
On January 14, it announced it would sell its aligners directly to dentists and orthodontists, placing it in direct competition with its ex-partner Align Techology's Invisalign. Earlier in the month, SmileDirectClub announced its exclusive partnership with Walmart to sell an oral care line, and it was expanding into Hong Kong. Its clear-aligner therapy already is available in the U.S., Canada, Australia, New Zealand, the U.K., Ireland, and Germany.
SmileDirectClub, which had been on rocky ground since it announced its initial public offering in August 2019, saw its shares soar following the news of its new ventures.
