Dental Tribune United Kingdom Edition

For 3D Imaging, please read on... www.velopex.com Call: 020 8965 2913 Email: enquiries@velopex.com let Velopex Lead You into the Digital Future... Proud of our 50 Years in Quality Imaging, DTo3ds27.04.11rpc T ooth whitening prod- ucts have been at the centre of much specula- tion and discussion throughout Europe for many years. The view as to whether whitening products fall into the category of cosmetics or are in fact a “medical device” remains a divided and undecided one be- tween the UK and Europe. During recent years several cases that went to court backed by scientific papers failed to change the opinion of the UK courts and the fact remains that in the UK under the 1976 Cos- metics Directive Council direc- tive 76/768/EEC provides in Annex III, part 1, n°12 a, whiten- ing products do not fall under “medical devices” and therefore cannot exceed a stated dose of 0.1 per cent hydrogen perox- ide. Following a House of Lords Judgement in June 2001, all tooth whitening products are considered to be cosmetics and not medical devices. The Cos- metic Directive does not require CE marking. One argument that has been brought to the retailers’ atten- tion from one dental supplier is that the commonly used concentration of 10 per cent carbamide peroxide releases about three per cent of hydro- gen peroxide; however, using a product with 0.1 per cent avail- able hydrogen peroxide is un- likely to be an effective tooth whitening agent. As a result, many UK products have about three per cent or more and so are currently, under the legal requirements, illegal. With this in mind, the re- cent whitening issue that has come to light is once again causing grave concern for den- tists throughout the country. Earlier this year in Janu- ary 2011, a patient complained to a dentist about their tooth whitening treatment; the issue was brought to the attention of the Trading Standards Au- thority (TSA), and the Trading Standards Officer informed the dentist to stop offering tooth whitening and forced his den- tal supplier to stop selling tooth whitening products altogether: the case is threating to reach the courts. The consequence of this situation has resulted in a sud- den suspension from dental suppliers in supplying whit- ening products. However, the grounds on which the involve- ment of the TSA was proposed remains obscure. Since the sit- uation Trading Standards Offic- ers have cautioned suppliers, resulting in some companies to immediately stop selling all tooth whitening products; however in other cases Trading Standards Officers have turned a ‘blind eye’ and the distribu- tion of prescription whitening treatment has continued. It would seem that it all comes down to interpretation. Speaking to Chris Wilson, City Trading Standards Man- ager, he was only able to say on the current situation that: “Our inquiries are continuing and we cannot comment further until legal proceedings have been completed.” With no clarity regarding the situation, the position that dentists are finding themselves in is an alarming one, as they must consider whether to con- tinue providing the popular cosmetic treatment or to cease using it. Speaking to Dr Wyman Chan, a dedicated teeth whit- ening dentist from Smile Stu- dio, London, it was noted that the UK is the only country in the world where it is essential- ly illegal to practice tooth whit- ening because anything which has a percentage of hydrogen peroxide of more than 0.1 per cent is classed as illegal. Speaking on the origins of the law, Dr Chan pointed out that originally the regulation under the ECC Cosmetic Di- rective was designed to regu- late oral hygiene products like mouth rinse and tooth- paste that were freely and di- rectly available to the consum- ers as Over The Counter (OTC) products. However, the area in which the law has been defined to label tooth whitening prod- ucts is so grey that it now gov- erns dentists instead of helping them. As Dr Chan explained, tooth whitening products do not fall into the category of an OTC oral hygiene product. Delving further into the de- bate, into yet another area of the law that remains grey and obscure, Dr Chan stressed that when tooth whitening prod- ucts are provided to patients for treatment it is a case of the products are prescribed to patients and NOT supplied to patients. To solve the confusion and the issue that dentists are be- ing confronted with on a daily basis, Dr Chan believes that the ideal situation would be for a Trading Standards Officer to take him to court to present a test case. Currently, the law can be interpreted differently, as Dr Chan has experienced, and Trading Standards Officers have the power to read into the law as they see fit: this means varying results for dentists across the country if they are brought to the attention of the Trading Standards Authority. As Dr Chan argues, if the dispute of the law is taken to court, there would be no more doubts and whitening products can be reclassified to their cor- rect field. With the threat of the above case looming over many dental practices and dental suppliers, could it be that tooth whitening will soon be a forgotten treat- ment? Considering that accord- ing to a poll of dentists of the American Academy of Cosmet- ic Dentistry (AACD), whitening is a trend that will continue to rise throughout 2011: This cur- rent case could not have come at a more inappropriate time. The poll recorded that AACD members performed an aver- age of 77 whitening treatments last year, and 57 per cent said that they expect this number to increase. We’re prescribing, not supplying Dental Tribune looks at the current whitening debate The future of tooth whitening products lies within the law ‘When tooth whitening products are pro- vided to patients for treatment it is a case of the products are prescribed to patients and NOT supplied to patients’ page 10DTà 9News & OpinionsJune 6-12, 2011United Kingdom Edition