Standards and Practices

In order to avoid legal action and ensure client safety, it is IMPERATIVE that all companies in this industry take EXTREME caution in the strength and quality of products you are offering, how you conduct whitenings, and the language you use on your websites and ALL promotional materials. For many or possibly all of you much of this is old news but with each cease and desist there are included copies of advertisements, pages of websites, etc utilizing language and protocols that are absolutely asking for legal action by putting yourself in the scope of “practicing dentistry” without a license. As many of you have discovered in your own research, the definitions are rather vague leaving interpretations rather open as it applies to our business being within the scope of Dentistry. That said, it is crucial that all companies in this industry err on the side of caution and conservatism.

Many of us have different business models, but whether you are doing whitenings yourself in malls/tradeshows, selling systems to spas/resorts, etc it is imperative that we move towards some “best practices” for ourselves and our accounts we sell to that will help us avoid exposing “low hanging fruit” opportunities for the Dental Boards. If it even slightly appears questionable and raises any concerns, avoid it. While we will continue to develop this document, some of the key items many of you are well aware of are below. Note these are my opinions from research and outside legal guidance thus far and if you have any additions, recommendations, or offerings to the contrary please let me know.

Product Quality/Safety/Strength

Take care to choose high quality suppliers with proper credentials and certifications. GMP and ISO9000 protocols are the most recognized to ensure quality. It is also prudent to be listed as an additional insured on their manufacturer policy if possible along with having your own coverage.
Given that all whitening systems we are offering do not provide for a gingival barrier to protect the gums as do the products from Zoom & BriteSmile which utilize MUCH stronger chemicals, it is strongly advised to be very cautious on the strength of product you are using for chairside whitening and any take home retail products. While there are NO published guidelines currently from the FDA or the American Dental Association discerning which strength levels are Over-the-counter or not, most all companies are not using any strength higher than 9% hydrogen peroxide or 30% carbamide peroxide for the chairside whitening under the light. Again, there are no official guidelines published but some incidences have proven that if gels of higher strength are exposed to the gums during whitening under the light, mild to severe “burning” and sensitivity may occur. As for take home, non-light retail products, higher strengths are often used with most products not exceeding 12% for hydrogen peroxide or 35% for carbamide peroxide. These are only observed generalized strengths but a good rule of thumb when considering gels you are using for your whitening systems and retail products.
Make sure that all components of any mouthpiece or other items used that go into the client’s mouth are individually packaged to ensure sanitation and product quality
Do not ever “reuse” any of the items that are meant to be disposable such as the mouthpieces. May seem to be common sense but some companies are employing this method by “sterilizing” them and using them over with new clients
Have a sanitary disposal method for the mouthpieces by employing the use of a biohazard bag some other plastic bag that can be sealed before placing in an open waste basket

Protocol

You must truly adhere to the concept we are all claiming: Self-Administered. Obviously no touching of the mouth or anything that touches or goes into the mouth such as an insertable mouthpiece that takes a “bite retention” and gel is inserted. The client must insert and remove the mouthpiece on their own and it is strongly advised that the actual client apply the gel or foam strips in the mouthpiece. I know with those using the insertable foam strips that this may be more challenging for the client to do so hopefully a movement towards a “preloaded” mouthpiece with the pads already included is soon available. Those using “bite retention” silicon mouth trays are trying to move towards prefilled as well which takes question out of the entire process.
Make sure to ALWAYS wipe down the mouthpiece of the light after each client to disinfect any accidental touching of the client’s mouth to the light mouthpiece during the whitening.
Make sure that you have a comprehensive “Informed Consent” document that every client must review and sign prior to whitening outlining realistic expectations, any oral health issues that may lead to damage from the whitening, and absolving you and/or your accounts from liability. Please review the Informed Consent template provided as a benchmark.
As noted further below, make sure to not overstate expectations about results and encourage multiple session purchases upfront as we all know the best results are achieved with multiple sessions. Given the margins available in this business, avoid angry customers and default to offer refunds when appropriate.
With regards to your lights it is advised to ONLY use L.E.D. lights and avoid using Plasma lights as it is our understanding these are exclusively for dentist purchase and use
Regardless of where your light comes from, domestic but most likely imported, confirm with your supplier in the US or abroad that it is registered with the FDA which is different than 510K premarket notification. From my research it is clear that whitening lights CFR872.6475 are Class I exempt from premarket notification which is the process by which a light is evaluated and defined as “for Prescription Use” However, some companies have, while not at all required, submitted their lights for 510K premarket notification which forces the FDA to make a judgment on whether or not it is for “prescription use” or “over the counter” which can go the wrong way as there is no “cosmetic” category for devices with the FDA….only Dental classifications.

Language

This is one of the MOST significant areas of caution which has been the primary cause of every legal action to date. It is IMPERATIVE to immediately review your websites and all promotional literature to ensure avoidance of the terms below. While some of the words listed below may seem to be “harmless” cases are being brought on a “word by word” basis used in advertising promotion and every hook available to the Dental Boards will be used to build a case. Before reviewing the specific vocabulary it is important to know how most states are “defining” dentistry which is most commonly anyone who “offers or professes to offer the action of removing stains or performing any dental procedure of any kind. Note that State dental laws are subject to the broad oversight, regulation and interpretation of state dental boards. Such boards are given broad discretion to interpret and regulate such laws. According, such laws can easily be interpreted or enforced in a manner that is more restrictive on any of our company’s products and the application thereof. Below are highlights from a few states I have pulled together.

Arkansas

The practice of dentistry includes, among other things, directly or indirectly representing one’s self as being able to remove stains from one’s teeth; and offering or undertaking by any means or method whatsoever to remove stains, concretions or deposits in the human mouth. It is unclear, however, whether selling the product and providing verbal instructions on how to use the whitening gel and/or accelerator apparatus on-site would constitute the practice of dentistry.

Alabama

“Dentistry” has a very broad and ambiguous definition which may be construed to include the application or the assistance in the application of whitening products, and even verbal instructions regarding the application of the product, especially if stained teeth were considered to be a “deformity, deficiency, or physical condition.” Dentistry includes anyone who “performs, or attempts or professes to perform, any dental operation or dental service of any kind,” or who “diagnoses, or professes to diagnose, prescribe for, professes to prescribe for, treats or professes to treat disease, pain, deformity, deficiency, injury or physical condition of the human teeth.” It is unclear whether the mere assistance or instruction would constitute dentistry since the employee would not be directly “treating,” but may be “professing to treat.” Dental hygienists, only under the direct supervision of a dentist, may remove accretions or stains from the teeth.

Arizona

“Dentistry” has a very broad and ambiguous definition which may be construed to include the application or assistance in the application of whitening products, and even verbal instructions regarding the application of the product. Dentistry is “the evaluation, diagnosis, prevention and treatment of human diseases, disorders and conditions of the oral cavity, the maxillofacial area and the adjacent and associated structures within the dentist's scope of education, training and experience and according to the ethics of the profession and applicable law.” If stained teeth are considered “condition” of the oral cavity, the application of tooth whitening products may be considered dentistry. However, it is unclear whether the mere assistance or instruction would constitute dentistry since the employee would not be directly “treating” the client.

Idaho

“Dentistry” has a very broad and ambiguous definition which may be construed to include the application or the assistance in the application of whitening products, especially if such application or assistance is considered “examining, treating, repairing, or correcting” the teeth. A person practices dentistry who, among other things, “examines, treats, or corrects” the teeth. However, it is unclear whether the mere assistance in the application of providing verbal instructions would constitute dentistry since the employee would not be directly “treating, repairing, or correcting” the teeth.

Montana

Dentistry has a very broad definition that likely includes both the application and assistance in the application of whitening products, and even providing verbal instructions, if tooth whitening is considered a “dental service of any kind.” Dentistry includes directly performing, instructing, or causing the patients to perform a “dental service of any kind.” The dental regulations do not define the phrase “dental service of any kind,” however, a person who “treats, or professes to treat . . . deformity, deficiency . . ., or physical condition of human teeth,” is considered to be practicing dentistry. If stained teeth are considered a “deformity, deficiency, or physical condition,” then the application of products to treat them would likely be considered dentistry in this definition as well.

Texas

Dentistry likely includes both the application and the assistance in the application of whitening products, and perhaps even providing instructions on the application. A person practices dentistry if he or she, among other things, represents to the public that he or she is able to remove stains from the teeth or performs or offers to perform by any means the removal of stains from the teeth. Thus, even supplying a tooth whitening product and providing verbal instructions on its use may be considered the practice of dentistry since the employee may be “offer[ing] to perform by any means the removal of stains.” In addition, a dentist may not delegate the task of the removal of calculus, deposits, or accretions from the surfaces of exposed human teeth to a person not licensed as a dentist or dental hygienist.

Vocabulary and Verbiage to AVOID using

Professional – use “cosmetic”
Stains – use “discoloration”
Removing – don’t use it at all even with “removing discoloration” instead use “addresses discoloration on the teeth”
Treatment or Procedure – use “whitening session”
Patient – use Client or Customer
Syringe – use whitening applicator
Avoid making any reference that your service is like dental bleaching or “uses the same technology” as dental whitening. In fact we have specifically made it clear that it is not the same but delivers outstanding results at an affordable price compared to “other offerings” not “dental whitening”. There are very specific cease and desist letters citing these types of language infractions when drawing comparison to Dentists or offering the “the most advanced” whitening system available. This diction positions your system as something it is not and will most assuredly draw attention and offer very easy targets for the Boards.
Make sure to not overstate results and expectations

Training & Education

It is imperative to create a thorough Training Manual to educate about your specific approach to teeth whitening thorough that will also touch on the topics addressed in this document
Make sure to have “above average” competent staff if you have corporately owned facilities. Seek out individuals with some kind of experience in the health/beauty/spa industry that already have an understanding of these types of protocols. Implement STRONG accountability standards for staff to comply with the protocols you have set forth with termination as a result for lack of compliance
If you are selling teeth whitening systems to spas/salons/resorts/individuals, it is advised to create a signoff system that all staff involved with teeth whitening at the facility have read and understand the Training Manual you have provided to them. In some cases, companies are issuing Training Certificates upon completion of the Training Materials.

CCTW

Council for Cosmetic Teeth Whitening