The ADA’s Continued Fight To Protect Consumers Against SmileDirectClub Is Very Much Alive

Chances are, by now, you’ve seen multiple commercials or ads for SmileDirectClub or other similar direct-to-consumer orthodontic treatments. Promising a perfect smile in 5 to 10 months straight through the mail. This is an instance where if it sounds too good to be true, it might be.

The American Dental Association (ADA) is fighting to set the record straight, educate the public, and protect consumers against possible undue dental damage.

 

SmileDirect offers clear aligners through the mail to customers as an alternative option to traditional orthodontic treatments. The company uses either a 3-D image of the customer’s teeth taken at a SmileDirect “SmileShop” or from an impression made using an online kit provided by the company. If the online kit is used, customers make bite casts at home themselves, which are then reviewed by a SmileDirect dentist online who approves a series of aligners for the customer. SmileDirect then develops and sends out the clear aligners to the customer to be used in a 5-to-10-month treatment plan.

The ADA is leading the fight against SmileDirect, and other similar companies offering direct-to-consumer orthodontic treatment. All to protect consumers from what the ADA describes as dental practices that are endangering patients.

 SmileDirect has faced the strongest opposition from not only the ADA but also the American Association of Orthodontists (AAO). The AAO filed complaints in 36 states alleging SmileDirect was practicing dental treatments illegally. The company continues to face criticism from dentists and orthodontists across the country who are also trying to protect patients.

On April 25th, 2019, the ADA submitted a citizen petition to the FDA “out of concern for public safety and customer recourse in the event of negative outcomes from SmileDirectClub’s orthodontic “treatment therapy.” The ADA’s main concern is the fact that moving teeth without a thorough exam and knowing all aspects of a patient’s oral condition and dental history can result in serious problems. SmileDirect is asking customers to self-report their dental condition. The ADA detailed in its citizen petition that it feels that “customer self-reporting does not meet the applicable standard of care because it does not satisfy a dentist’s requisite professional due diligence.”

The ADA’s Fight Is Still Very Much Alive

After learning of a response from the FDA to the ADA in regards to their citizen petition, SmileDirect issued public statements, including an October 4th press release, stating that the citizen petition had been thrown out. The ADA states that these messages from SmileDirect are inaccurate and misleading and are concerned that “statements that the ADA’s petition has been “shut down” or “dismissed” may deter customers who have experienced clinical problems in connection with SmileDirectClub’s aligner “treatment therapy” from reporting their negative experiences to the FDA.”

The ADA is fighting to inform the public accurately and set the record straight that its fight, and the citizen petition and complaints to the FDA, are still very much alive.

The FDA did not throw out the entire citizen petition, but stated in the response letter from May 30th, 2019, that they were dismissing the request for a direct injunction and enforcement against SmileDirect because those actions simply are not within the scope of the FDA’s citizen petition procedures. The FDA does not initiate enforcement on behalf of petitioners. The letter did not dismiss the informative and substantive aspects of the ADA’s citizen petition. The FDA further states in the letter:

“We appreciate the information [the ADA] provided. Such information is often helpful for us to identify problems with marketed products and possible violations of the laws and regulations that we enforce. We take complaints seriously and we will evaluate this matter to determine what follow-up action is appropriate.”

All of the issues and concerns raised by the ADA’s citizen petition remain fully before the FDA for investigation at this time. 

In June of 2019, the ADA also submitted a complaint to the Federal Trade Commission (FTC) to urge the commission to investigate what the ADA states are false and misleading claims and deceptive practices. In the FTC complaint, the ADA points out that plastic teeth aligners, like the ones sold by SmileDirect, are designated by the FDA as a Class II medical device that requires a prescription. The ADA believes that SmileDirect is knowingly evading the FDA’s “by prescription only” restriction and subsequently placing the public at risk. This is also still being investigated by the FTC.

The ADA also argues that if the citizen petition against SmileDirect had been “shut down”, the company would not have included the ADA’s petition as a known “risk” in the “Risks Related to Legal and Regulatory Matters” section of SmileDirect’s August 12, 2019, S-1 filing with the U.S. Securities and Exchange Commission. SmileDirect did go public in September.

 

New Legislation Extending Consumer Protection

The ADA’s fight has garnered attention and caused more and more within the dental and business industries, as well as those within the government to take a harder look at companies like SmileDirect.

In a report published in October of last year by Hindenburg Research, it was noted that more than 1,200 Better Business Bureau complaints have been registered in SmileDirect’s five years of existence. It was also noted that dental boards in Alabama and Georgia have deemed some of its practices illegal.

The volume of complaints against direct-to-consumer orthodontic treatments already, as well as other states taking measures is what helped drive California Governor Gavin Newsom to sign a new law into effect regarding “teledentistry”, the business model used by SmileDirect. The new legislation changes the rules on “teledentistry” and includes protections for patients who undergo direct-to-consumer orthodontic treatment from companies like SmileDirect. A provision is included that allows customers to submit complaints to the Dental Board, even if they have signed a nondisclosure agreement.

Those extended protections were included in the legislation after growing opposition to SmileDirect from dentists and orthodontists not only in California but across the country, who have been critical of the company’s business model of direct-to-consumer orthodontic treatments.

Trust A Professional For Your Orthodontic Treatments & Dental Health

Any dental or orthodontic procedure requires a thorough in-person exam and x-rays to customize a safe and effective treatment plan for each individual. This is important because a mistake can cause potentially expensive permanent damage such as broken teeth, tooth or gum loss, bite issues, and other problems. Seeing a trusted orthodontic professional in person can mitigate the risk of mistakes, prevent damage, and ensure your optimal dental health.

If you are considering direct-to-consumer orthodontic treatments, like those offered by SmileDirect and similar companies, it is important to do your research and ask questions. The AAO offers a comprehensive list of things to consider and questions to ask, for example:

  • As part of your treatment with these aligners, are x-rays and other comprehensive diagnostic records taken before your treatment?  
  • As part of your fee for treatment, do you receive any in-person visits to a dentist’s or orthodontist’s office?  
  • If a dental professional is involved with your orthodontic treatment, how can you contact him or her? How can you contact him or her if an emergency comes up?

You can trust the professionals at Cook & Gutsche Orthodontics to offer the most comprehensive, safe, and tailored orthodontic treatments for you. Our professional and caring team has the experience and expertise you can trust. Contact us to schedule your free orthodontic consultation today!