Tooth Whitening

There is currently continued confusion relating to the legal position of dentists using tooth whitening techniques which involve the use of bleach.

Background
There had been concerns regarding the use of strong concentrations of hydrogen peroxide in the hairdressing and beauty industries, both in terms of the risks to the public and to the workers in these sectors. An EC directive in 1984 sought to regularise the situation and Regulations to implement this were introduced in the UK in 1989. However, it was then realised that some home tooth bleaching products and some products used by dentists in their surgeries might not be captured by the Regulations and a new EC directive 92/86 led to further UK legislation that came into force in 1993. This was really the first moment when this issue impacted upon the dental profession.

The legal situation today arises in part as a result of action taken against the Department of Trade and Industry and the Department of Health by a manufacturer and distributor of a bleaching product which contained Carbamide Peroxide. Whilst the company in question was successful in its initial case against the two government departments, the Judgement was subsequently overturned on Appeal and the Appeal Court decision, in turn, was upheld by the House of Lords in 2001. The situation at present is therefore that it is illegal in the UK to supply a product for the purpose of tooth whitening, if that product contains or releases more than 0.1% Hydrogen Peroxide.

Whether or not a product falls within the terms of the European Council Directive on Cosmetic Products 76/768/EEC is determined by its use. The decision in the House of Lords was taken notwithstanding the fact that the product in question carried with it a European CE Mark, which would normally allow such products to be marketed as medical devices. The House of Lords in 2001 held that the Government had the right to consider bleaching products as falling under the EU Cosmetic Directive and therefore within the terms of the UK Cosmetic Products (Safety) Regulations 1996. Subsequently these regulations have been replaced by the UK Cosmetic Products (Safety) Regulations 2004.

Although it has yet to be tested, Dental Protection's advice is that the Judgement is likely to cover all bleaching products that release more than 0.1% Hydrogen Peroxide, regardless of whether they are administered chairside or provided to a patient to take home. This produces a particular dilemma for dental practitioners who may be concerned that patients are being denied a treatment that is both safe and effective. Dental Protection is not an arbiter of clinical opinion; nevertheless, there appears to be a considerable weight of authoritative scientific opinion to support the use of these techniques, particularly when considering the destruction of healthy tooth structure which is necessary with many of the alternative techniques.

Are there changes forecast?
Changes to European legislation have been forecast since 2001 when the dental professions in Europe came to realise the full extent of how the current European legislation would limit the dental use of these products, and present dentists with a wholly invidious ethical and legal dilemma. Since that time there have been numerous attempts to change the legislation. Successive expert committees of the European Commission have made recommendations including the Scientific Committee on Cosmetics and Non Food Products (SCCNFP) which was subsequently replaced by the Scientific Committee on Consumer Products (SCCP).

An opinion from this Committee, dated 15 March 2005 (SCCP/0844/04), concluded that the use of tooth whitening products up to 0.1% Hydrogen Peroxide is safe. It also concluded that the proper use of tooth whitening products with greater than 0.1% but less than 6.0% Hydrogen Peroxide was safe, after consultation with and approval of the consumer's dentist. The Committee laid down certain caveats, namely that the use of tooth whitening products is not recommended prior to or immediately after dental restorations and that particular care should be taken in the use of these products by persons with gingivitis or other periodontal diseases or defective restorations. Conditions such as pre-existing oral tissue injury or concurrent use of tobacco and/or alcohol may exacerbate the toxic effects of Hydrogen Peroxide.

The Committee also commented that there was an absence of good clinical data and long-term epidemiological studies that assessed the possible adverse effects within the oral cavity.

Following consideration of that advice the Commission then proposed that tooth whitening products would be available over the counter up to and including 6.0% Hydrogen Peroxide. The European Union of Dentists did not feel that this was a safe proposal, in the light of advice from SCCP, and objected. In October 2006, the Council of European Dentists wrote to the Head of Unit, Cosmetic and Medical Devices in Brussels, raising their concerns about over-the-counter products being available, when the scientific advice of the SCCP was to the contrary.

The Council of European Dentists has also made a submission to the Commission on the issue of whether it is appropriate to regulate tooth whitening products over the 0.1% solution as Cosmetics, when they might alternatively be regulated under Medical Devices legislation. This goes to the heart of whether these procedures are essentially cosmetic, or therapeutic in nature.

The SCCC opinion (Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products) that was adopted in December 2007 and released in January 2008, is a welcome step, but it would be premature to believe that it concludes the debate on tooth whitening. This report (and the committee which produced and adopted it) is advisory in nature. It is also another quite cautious report from SCCC, suggesting on the one hand that limiting the use of products in the 0.1% to 6% hydrogen peroxide category, to situations that have been preceded by a clinical examination and diagnosis (presumably by a registered dental healthcare professional who is legally permitted to do this), and where the frequency and duration of usage can be reliably controlled, could together significantly minimise any risk to the public. Both recommendations are helpful to the dental profession because they limit over-the-counter supply and preclude the use of these products by others outside dentistry. On the other hand, the report once again highlights the continued absence of good clinical data and long-term epidemiological studies - which is a perfect invitation to further delays in resolving this debacle.

Whether or not this opinion will now be sufficient to persuade the European Commission that a new Directive should be issued, remains to be seen. Until that happens there is no scope for any EC member state to change its existing national legislation - and that is the key to any sustainable solution for the UK dental profession.

The local effect
In the UK it is the General Dental Council and various Trading Standards Officers that are having an impact on the provision of tooth whitening products.

The GDC regards tooth whitening as the practice of dentistry and has signalled that it will seek to prosecute those who are not registered and who provide tooth whitening. It has also stated that it is currently of the view that bleaching should only be carried out by dentists. This may conflict with its guidance in respect of DCPs, namely that they should act within their competence and training. There is no longer a list of duties for DCPs and accordingly there is some potential for confusion. DCP members who are considering the use of tooth whitening products should take advice from Dental Protection as it is our view that they are likely to be challenged by the GDC if they are providing tooth whitening products and are not a registered dentist. This is a very fluid area at the moment and the situation may change in the light of other cases and complaints to the GDC, and the GDC's own reflection upon the first such case that came to be considered by the Professional Conduct Committee in late 2007.

Trading Standards Officers
The Cosmetic Products (Safety) Regulations impose a criminal liability on those breaching safety requirements, with a maximum sentence of imprisonment not exceeding 3 months. The Local Authority has a duty to enforce safety provisions within its area and can initiate its own investigations without being restricted to the need to react to specific complaints.

A Trading Standards Officer has a right of entry into a dental practice (at a reasonable hour and on production of credentials, if asked) under Section 29 (2) of the Consumer Protection Act 1987. The officer may inspect any goods and enter a dental practice for the purposes of ascertaining whether there has been any contravention of any safety provision.

Obstructing a Trading Standards Officer in exercising his duty can constitute an offence in itself. If admission is refused an officer can apply to the Magistrates for a warrant (Section 30 (2) Consumer Protection Act 1987) to enter the premises.

If a member feels s/he is at risk of being prosecuted for a breach of safety regulations s/he should treat any proposed interview with Trading Standards Officers with the same circumspection as s/he would a police interview. In this situation members are advised to contact Dental Protection for further advice.

In view of the frustrating lack of progress in Europe, LACORS, which coordinates Trading Standards Offices, re-considered its hitherto laissez faire policy and advised its Trading Standards Officers to apply the law as it stands. Unfortunately LACORS cannot selectively apply the law to one part of the population (eg. non-dentists), and ignore illegal acts by others (eg dentists). This raises the possibility that a dentist could be challenged by a Trading Standards Officer. To date there have been no prosecutions against dentists, however we do advise dental members to contact Dental Protection if they are contacted by a Trading Standards Officer.

The decision by LACORS to re-commence enforcement of the Cosmetic (Safety) Regulations has created some concern for dentists who fear that they may now be exposed to prosecution for breaches of the Cosmetic Products (Safety) Regulations 2004. Any conviction in this respect would automatically be reported to the GDC.

Is there anything dentists can do?
Dental Protection's view is that the best position a healthcare professional can take is to act in a patient¡¦s interests at all times. The recent advice from LACORS does not alter this position.

We continue to work with the various agencies and to lobby for change in the current legal status so that tooth whitening is available. This is important because for many patients the alternative is a more destructive and irreversible treatment approach which does not sit easily with current concepts of minimally invasive dentistry. We believe that dentists are currently being placed in an unacceptable 'Catch 22' situation whereby in order to comply with the law they might need to act unethically, and in order to act ethically they may need to act illegally. Such a dilemma is also contrary to the public interest.

Dental Protection's advice

• Take individual therapeutic decisions in respect of each patient.
• Avoid advertising the use of tooth whitening products as this may constitute intent to supply the goods beyond an individual therapeutic decision. It is also likely to attract unfavourable attention from local Trading Standards Officers.
• Take advice if you have concerns or are approached by a Trading Standards Officer.
• If you have concerns about providing tooth whitening products then consider delaying treatment until the legal situation is resolved, rather than proceeding to provide more destructive techniques. Most elective procedures can be deferred.
• Ensure that patients are fully informed as to the risks and benefits of both bleaching procedures, and the more interventive alternatives, including a discussion about the current legal status of tooth whitening procedures.
• Document all consultations carefully in the patient's clinical notes - this is essential in order to demonstrate that appropriate discussions have taken place with the patient before the procedure is carried out.

Summary
Any member of Dental Protection who is challenged in relation to the use of bleaching techniques in their treatment of patients can look to Dental Protection for advice, assistance and support.

Updated March 6 2008