June 20th, 2011
Tooth Whitening A Historical ViewRecent events in the world of bleaching have prompted a need for a lesson in the history of tooth whitening in the UK. Here are the facts in chronological order.
Optident sells a tooth whitening product in the late 1990s as a class 2a medical device with CE mark certified by TUV in Germany. Government refuses to recognize the CE mark and considers the product as cosmetics, thereby making them illegal due to cosmetic bleaching only permitting 0.1% hydrogen peroxide.
Optident challenges this in court, claiming the product is a medical device and wins. The government appeals in high court and wins. Tooth whitening products are cosmetics and those with over-the-allowed percentage of bleach are banned. Optident appeals at the House of Lords and loses. Tooth-whitening products are cosmetics and those over-the-allowed percentages of bleach are banned. Optident asserts that that the best way to deal with the issue is to fight for the products to be classified as medical devices, thereby freeing up the percentage of bleach. A few years pass and whitening products become increasingly available in the UK sous la table. The BDA, chief dental officer and general dental council all confirm in writing that the clinical procedure is legal. LACORS (the agency that advises Trading Standards) memos all officers to issue a laissez-faire approach to tooth whitening and the products. Throughout this, no dentist has been approached or prosecuted or threatened, more whitening products with high and higher concentrations of bleach appear on the market.
Dental dealers start to sell the products. MPs, ministers, celebrities and prime ministers all have tooth whitening. Tooth whitening becomes easily the most demanded dental treatment in UK dental practices. There are various discussions with the European Parliament to lift the allowance bleach in tooth-whitening products: all of which are still ongoing 12 years later.
Europe continues to tooth whiten with a sensible approach, accepting the medical devices CE mark. Optident continues to assert that the best way to have tooth-whitening products legalized is through the medical device route.
Gordon Christensen once said the decision to ban tooth-whitening products in the UK was absurd. Tooth whitening has been accepted by the official dental organizations of the world, including the US. In my opinion it is not the domain of governmental agencies to control or dictate scientific or clinical policies beyond their realm of education and experience.
In the last few weeks, rumours have been rife about patients complaining, dentists being stopped from tooth-whitening and dental suppliers banned from selling tooth-whitening products. Several trading standards officers have visited dental companies and stopped them selling branded kits for the purpose of tooth whitening, particularly the take-home kits. A patient in the North East did complain to trading standards officers and a practice was visited and illegal product confiscated. The good news is that the public and its elected officials want tooth whitening and tens of thousands of patients a year to enjoy safe tooth-whitening treatment here. Common sense should prevail at some point because the situation is a mess. In hindsight, a group effort to petition UK regulatory bodies with a clinical case for tooth whitening products to be classified as medical devices would have been the right way forward. But too often humans take the path of less resistance.
For branded tooth whitening products with any significant amounts of bleach, in the UK only, the law says it is illegal to supply, illegal to make, illegal to buy. But the technique of tooth whitening is legal, and even dento-legally negligent not to offer it as an alternative to invasive treatment.
Deal with patients more carefully than you normally do, perhaps by using tooth whitening as part of a responsible treatment plan.
Why was the Optident judgement in favour of only dentists using tooth whitening products as medical devices initially appealed by the government? If we can find out the thinking there, perhaps this situation can be resolved in the future.
No dentist has ever been prosecuted for tooth whitening in the UK.
For more information on tooth whitening please call 01432 272238.