011111;]er cf the ?nite?! gvtatea
211515

January 6, 2020

Jeff Shuren, MD.

Director, Center for Devices and Radiological Health
Food and Drug Administration

Department of Health and Human Services

10903 New Hampshire Ave

Silver Spring, MD 20993-0002

Mrs. Mary Engle, .D.

Associate Director, Division of Advertising Practices,
Bureau of Consumer Protection

Federal Trade Commission

600 Avenue, NW

Washington, DC 20580

Dear Director Shuren and Associate Director Engle:

We write to express our concern regarding SmileDirectClub, LLC (?SmileDirectClub?),
especially when we see more than 1,350 ?Customer Complaints? on the Better Business
Bureau?s website for the company, as well as press reports highlighting signi?cant issues with
the business model and product. SmileDirectClub?s ?Customer Complaints? are coupled with
questions and concerns about SmileDirectClub?s 510(k) registration with the Food Drug
Administration (FDA) and SmileDirectClub?s questionable advertising practices that would be
subject to the Federal Trade Commission?s jurisdiction.

Orthodontic aligners, like those sold directly to consumers by SmileDirectClub, are intended to
move teeth as part of orthodontic treatment. As health care providers, we know that orthodontic
treatment, if performed without the proper diagnosis and supervision by a dentist or orthodontist,
could lead to potentially irreversible damage such as changed bites, gum damage, and tooth loss.
For patients who experience some of these negative outcomes, they may require additional and
costly treatment from dentists and orthodontists to try to correct the damage. We are also
concerned by the notion that when medical products, like the ones SmileDirectClub sells, are
sold and constantly advertised in normal commercial channels, the general public may assume
they are completely safe, because, as we have heard, ?If they weren?t safe, they wouldn?t be
allowed.? This seems contradicted by the numerous ?Customer Complaints? on the Better
Business Bureau?s website that appear to be clinical in nature.

Given the foregoing concerns and those voiced by the American Association of Orthodontists,
we write to express our strong support of the FDA and the FTC investigating the practices of
SmileDirectClub to ensure that it is not misleading consumers or causing patient harm. We

1 1672
I See 

PRINTED ON RECYCLED PAPER

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.

 

 

Sincerely,

5% Q7 
Brian Babirl, D.D.S. Paul A. Gosar, DD

Member of Congress Member of Congress

  



Mike SimpsonNiMD. (V

 

A. Drew Ferguson IV. D. M. D.

 

 

 

Member of Congress Member of Congress
4% 7\ WJQM
Jeffj/ an Drew, D.M.D. David P. Roe, MD.
Member of Co gress Member of Congress

 

 

 

And)? Harris, MD. 

Member of Congress ?ber of gr
5?4?ch @237

Earl L. ?Buddy? Carter?

Member of Congress