ADA Sets Record Straight on Status of Petition to Food and Drug Administration Regarding SmileDirectClub

Statement may be attributed to Dr. Chad Gehani, American Dental Association president

The American Dental Association (ADA) believes the public has a right to accurate information concerning the status of its pending  citizen petition submitted to the U.S. Food and Drug Administration (US-FDA) about SmileDirectClub, LLC’s direct-to-consumer plastic teeth aligner business. SmileDirectClub’s (SDC’s) inaccurate public statements that the ADA’s petition has been “shut down” or “dismissed” may deter customers who have experienced clinical problems in connection with SDC’s aligner “treatment therapy” from reporting their negative experiences to the US-FDA.

SDC’s public misstatements, including in its Oct. 4 press release, are apparently based on a May 30, 2019 letter from the US-FDA to the ADA. The letter, which can be viewed at the citizen petition landing page, did not reject or dismiss any substantive aspect of the ADA’s citizen petition. The US-FDA’s letter explains:

“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.”

The letter further explains that the US-FDA does not initiate enforcement actions on behalf of petitioners. Instead, the US-FDA reviews the submitted evidence and decides for itself what action to take. All substantive issues raised by the ADA’s citizen petition remain fully before the US-FDA at this time. The comment period for the public to address the petition and for the ADA to supplement the petition is open until Oct. 22 at 11:59 pm.

Further proof of the continuing pendency of the ADA citizen petition is SDC’s acknowledgement of it in the “Risks Related to Legal and Regulatory Matters” section of SDC’s Aug. 12, 2019 S-1 filing with the U.S. Securities and Exchange Commission. Had the US-FDA dismissed the ADA’s citizen petition, there would have been no reason for SDC to mention the petition in its securities filing, and certainly not to identify the regulatory proceeding as one of SDC’s existing “risks.”

The ADA submitted its citizen petition and a complaint letter to the Federal Trade Commission’s (FTC) Bureau of Consumer Protection out of concern for public safety and customer recourse in the event of negative outcomes from SDC’s orthodontic “treatment therapy.” Plastic teeth aligners are designated by the US-FDA as a Class II medical device requiring a prescription. The ADA believes SDC is placing the public at risk by knowingly evading the US-FDA’s “by prescription only” restriction.

In lieu of having dentists review patient dental records or perform any sort of patient exam (whether using teledentistry or otherwise) before prescribing orthodontic treatment, SDC instead requires customers to self-report their dental condition. As the ADA explains in its citizen petition, customer self-reporting does not meet the applicable standard of care because it does not satisfy a dentist’s requisite professional due diligence. Put simply, SDC and the small number of “SDC-affiliated” dentists have no way of knowing whether a lay consumer’s self-reported dental condition is accurate, informed, or true in any respect.

Moving teeth without knowing all aspects of a patient’s oral condition has the potential to cause bone loss, lost teeth, receding gums, bite problems, jaw pain, and other issues. Despite these potentially serious outcomes, SDC requires its customers to hold the company harmless from any negative consequences, as the ADA points out in its US-FDA citizen petition and FTC complaint letter.

In addition to these public health concerns, the ADA’s letter to the FTC cited various SDC practices the ADA believes to be deceptive under section 5 of the Federal Trade Commission Act, including:

  • Informing purchasers they have recourse against SDC via arbitration, when the same document includes a “small print” provision obligating the customer to waive any and all rights the customer “or any third party” may have against SmileDirectClub.
  • Soliciting customers by claiming that SDC aligners will correct their overbite, underbite, and crossbite conditions, or their “extreme” malocclusion. But after customers complain about poor clinical outcomes, SDC invokes other documents stating that its aligners cannot treat bite conditions at all and can only treat mild to moderate teeth misalignment, not “extreme” misalignment.
  • Claiming that SDC customers receive the same level of dental/orthodontic care as actual dental patients, when in fact SDC and its affiliated dentists provide virtually no care and, contrary to its claims, SDC does not use teledentistry.

The ADA considers it our public duty to make the relevant regulatory agencies aware of these facts, so those agencies can be fully informed and consider whatever actions they deem appropriate.

The US-FDA’s MedWatch voluntary reporting form may be used by both consumers and health care professionals to report poor clinical outcomes associated with medical devices, including plastic teeth aligners. The FTC also offers consumers an online form to report complaints about unfair and deceptive business practices on its website.

ADA News Release, originally appeared on Oct. 9, 2019 and can be found here.

Smiles Over 65: Oral Health in Your Golden Years

By Karen Weeks, Elderwellness.net

Many people mistakenly believe that missing teeth and poor oral health is simply par for the course of aging. The truth is that you can have healthy teeth and your own natural smile for a lifetime. To make this happen as you enter your retirement years, it may become necessary to pay even closer attention to your mouth. Healthy dental habits, such as brushing and flossing, are a great start, but you also need to get comfortable in the dentist’s chair.

But it Costs so Much …

One of the most pressing issues with seniors today is that dental care is expensive. And those with original Medicare are left to foot the entire bill when their teeth and gums are on the line. There is good news, however, in that you have choices when it comes to your Medicare coverage. Medicare Advantage plans from companies like Humana offer comprehensive health care coverage, and the majority of these private Medicare policies provide a wide assortment of dental benefits. And considering that your oral health can affect other aspects of your well-being, you can’t afford not to see your dentist.

Healthy Habits

If you’re not brushing and flossing at least twice each day, you should. According to the American Dental Association, cleaning your teeth, or dentures, can help keep bacteria out of your mouth. And when it’s not in your mouth, you have less of a chance of it spreading throughout your body. Flossing is likewise important and is the most efficient way to remove solid food particles from between teeth. Dry mouth is a serious concern for many seniors, so you also should make a point to drink plenty of water and quit smoking.

Potential Problems

Even if you establish a healthy oral hygiene routine, there are still issues that can arise. Sensitive teeth, for example, can happen over time with wear and tear. As the enamel on the outside of your teeth wears down, they may feel discomfort when exposed to heat or cold. Enamel is extremely strong, but it can be damaged by aggressive brushing, receding gums, or an acidic or sugary diet.

Cavities also are cause for concern if you don’t make your teeth a priority. Even though your adult teeth are stronger and more able to fight off decay than baby teeth, certain medical conditions, such as arthritis, can leave you less able to give your mouth the attention it deserves. Regardless of age, untreated cavities can cause pain and can make it difficult to eat like you are supposed to.

Health Conditions Can Affect the Teeth

Taking care of your dental health is exceedingly important if you suffer with age-related medical conditions. High blood pressure and diabetes, for example, are known to cause or contribute to gum disease. Obesity and rheumatoid arthritis also are linked to the health of the soft tissues in your mouth. Surprisingly, even less serious conditions, like acid reflux, can wreak havoc on your teeth. Gastroesophageal reflux disease (GERD) can push acid from your stomach into your mouth, and this acid can quickly wear away at your teeth. Stress, depression and many autoimmune diseases also can take a toll. For these reasons, you should make a point to visit your primary care physician for a full physical every year. Between the screenings they’ll offer and your regular dental checkups, your health care team can identify health problems that affect the teeth and vice versa.

It is possible to enjoy a beautiful smile and uninterrupted eating habits throughout your entire life. But it does take work, and a commitment to whole health. If you’re concerned about money, check your Medicare plan and make sure that you are covered.

Ms. Weeks can be reached at karen@elderwellness.net.

Why Dorian Should Make You Think About Practice Transitioning

By Dr. Rick Huot

At the end of August, while Hurricane Dorian was on its unpredictable path, I headed to San Francisco for the American Dental Association’s Annual Meeting. Before my duties started as ADA Board of Trustees liaison to the Standards Committee of Dental Informatics, I sat down to write this article in the relative comfort of the Marriott Marquis. Whenever I have the Weather Channel on for more than five minutes this time of the year while away from home, you can be assured that Joanne and I are checking to see how the “wind is blowing” back in Florida. In 2004, we spent Labor Day in Maine watching as Hurricane Frances — and three weeks later, Hurricane Jeanne — give Florida the infamous “Plywood State” moniker, and as empty nesters, it doesn’t take us long to pack and secure our home not knowing what the force of nature is planning for the week ahead.

Early that Friday morning, and with help from Delta, we decided to leave a day early for our trip to California, knowing that conditions in the Caribbean were deteriorating, and there was a good chance that flights all over Florida would start being cancelled as early as Saturday. That was confirmed by the Delta folks when they graciously put me on a plane leaving out of Orlando Friday afternoon.

After a quick call to Marriott and the shuttle folks, we now had an extra day to “play,” and we quickly contacted longtime friends from Chicago now living in San Francisco for dinner, and the conversation quickly shifted from Dorian to our respective careers. Helen has been working for Delta since I was in dental school at Northwestern and continues to fly the international routes and loves her work. Mike is a successful retired businessman who invested wisely in his career since his early days in Chicago, and this year’s New York Marathon will be the 100th he has run since he started many years ago.

These days, longevity experts talk about your early 60s and what you can reasonably expect life to play out from there. Given that you are in good health, and that you also have excellent financial health, your options multiply when you could adapt to life’s curveballs and make lemonade when someone like Dorian hands you some lemons.

Kiplinger Magazine has an excellent article on the “go-go years” and beyond, and we remarked that the four of us were taking this very seriously. At this point, you may be wondering what the above events have to do with dental practice transitions, but please keep reading on, and you will see the method to my madness.

After Hurricane Katrina in 2005, I was asked by Dental Economics to co-write an article on disaster preparedness, and lessons learned from surviving the 2004 hurricane season. Although some of the material is now dated, a lot of what was learned then is reinforced every hurricane season, and other natural disasters throughout the country all year long.

Given that the solo practice model has slowly become less prominent, and the cost of running a dental practice continues to increase, a dentist reaching the age of 50 has more options today available to them, especially if there is a chance that a facility could suffer damage that would prevent dentistry from happening for a prolonged period of time.

Retirement “catch-up” provisions allows dentists over 50 to set aside more income in pre-tax programs, and the proliferation of solo 401K plans allows dentists to sell their practices, contractually “workback” as an independent contractor to the new practice structure, and give the dentist more free time to enjoy life, while continuing to practice and share management responsibilities with younger dentists who desire the private practice model, but could use a little “on-the-job training,” eventually taking on a younger dentist with similar goals in the near future.

Today, most dentists approaching that age should be looking to partner with another dentist who has a similar philosophy of practice, especially if one of the offices is more “dated.” It should be noted that the business practice model of most dental service organizations (DSOs) call for at least two dentists working four-day weeks with extended hours, and covering the entire week, and sometimes including weekend hours.

Millennials and the new Generation Z coming of working age are more prone to “shopping” and have convenient hours as one of their prerequisites for selection of a dental office. A shared office space arrangement allows dentists to fulfill that desire, with minimum disruption, and allows them to offer the same convenience features as DSOs or large group practices.

Thankfully, it appears that most of Florida dentists fared well from this latest storm. The disruption to our practice lives disrupted patient care at least all that week and may have delayed some of the “snowbird migration” that we experience this time of the year.

Back at work, ask yourself these questions:

  1. Am I ready for the “go-go” years, regardless of what happens to my practice?
  2. Whom am I compatible with practice philosophy-wise in my area, and might we benefit from a joint location/dental practice, and a reduced cost of overhead?
  3. If my office was damaged, is the cost of rebuilding/repairing my space a good return on investment, given the amount of years I’m looking to practice in the future?
  4. Is it time to reexamine my financial strategic plan, and make some major changes? More boldly, is it time to downsize, and reduce the clutter and “stuff” we have accumulated?
  5. Are my contingency/practice succession plans up to date?

I’ve completed my term as ADA First Vice President, and it has been a privilege and honor serving our nation’s dentists and ensuring them clinical and financial success for the past two years. Be well.

Dr. Huot is a Fellow in the American College of Dentists, the International College of Dentists, the Academy of General Dentistry and the Pierre Fauchard Academy. He currently serves on the FDA Political Action Committee Board of Directors and served as ADA vice president for the past two years. He had a private practice from 1985-2008, still practices clinical dentistry and is the CEO of Beachside Dental Consultants, Inc., a practice management and health consultant firm. He can be contacted at drhuot@militarydentist.com.