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# ADA Asks FDA Action Against SmileDirectClub
- URL: https://www.fdaweb.com/ada-asks-fda-action-against-smiledirectclub/
- Published: 2019-05-02T12:00:00.000Z
- Updated: 2026-09-15T01:24:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144016

The American Dental Association (ADA) is asking FDA to take legal action against SmileDirectClub (SDC) which, it says, is “placing the public at risk by knowingly evading the ‘prescription only’ restriction that FDA has placed on plastic teeth aligners and on dental impression material. For all intents and purposes, SDC sells its plastic teeth aligners and dental impression material products to consumers over-the-counter.”

An ADA 4/25 [citizen petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2019-P-2038-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says that rather than have dentists perform patient exams to meet the applicable standard of care as the basis for prescribing orthodontic treatment, SDC “tries to protect its own commercial interests by requiring customers to self-certify their dental condition and then hold SDC harmless from any negative consequences suffered as a result of SDC’s aligner ‘treatment therapy.’”

The dental association asks FDA to: 

· move for an injunction against SDC’s further sale and distribution of its misbranded teeth aligner and dental impression material products;

· seek a condemnation and seizure order directed to SDC’s misbranded teeth aligner and dental impression material products;

· levy a significant civil penalty against SDC; and

· request SDC to voluntarily undertake a Class 1 recall of its misbranded teeth aligner and dental impression material products.

“SDC’s process for providing teeth aligners to its customers to correct malocclusion falls far short of even the most minimally acceptable standard of care,” the petition declares. “It is so woefully deficient in this regard that any putative ‘prescriptions’ generated as part of its customer transactions are no more than technical formalities without medical support or basis…. The instant petition is submitted in an effort to vindicate important regulatory principles, namely, that it is a serious violation of the law for a company distributing a restricted Class 2 medical device in interstate commerce to use false and misleading statements to entice consumers and to skirt restricted device prohibitions by declaring technical compliance with the statutes and regulations without substantive compliance.”

Contacted by ***FDA Webview***, SDC said, “We are aware of the citizen petition recently filed with FDA by the American Dental Association attacking SmileDirectClub’s approach of providing affordable, high-quality services to patients. The petition is filled with incorrect, misleading, and defamatory statements, and continues a pattern by entrenched interests of trying to prevent innovative, patient-first business models from disrupting the industry and increasing access to affordable dental care. SmileDirectClub’s clear aligners and dental impression materials are not ‘do-it-yourself’ or ‘over- the-counter.’ They are sold and manufactured pursuant to valid prescriptions from dentists or orthodontists licensed in the customer’s state. The SmileDirectClub network of state-licensed dentists and orthodontists not only creates a customized treatment plan designed specifically for a particular patient’s needs, but also directs and is responsible for all aspects of clinical care from the initial assessment of whether clear aligner therapy is appropriate through completion of treatment, including through regular check-ins.

“SmileDirectClub’s teledentistry platform has served more than half a million people in our mission to democratize access to safe, affordable, and convenient teeth straightening solutions. As our patient-first model gains acceptance with millions of consumers, retail partners, insurance providers, and a growing network of state-licensed dentists and orthodontists, organized dentistry has been ratcheting up its attempts to block competition. We will continue to educate the ADA and other stakeholders to correct misconceptions of our model, as we have with the American Association of Orthodontists, state dental boards, and other segments of organized dentistry.”