The Dental Board of Australia (the Board) has developed this fact sheet to explain the role of the Therapeutic Goods Administration (TGA) and the Australian Competition and Consumer Commission (ACCC) in regulating teething whitening products and what the Board expects of dental practitioners when using teeth whitening products in their practice.
The Therapeutic Goods Administration (the TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating therapeutic goods including medicines, medical devices, biological, blood and blood products.
The TGA administers the Standard for the Uniform Scheduling of Medicines and Poisons (commonly referred to as the Poisons Standard)1 which sets controls for teeth whitening products.
Schedule 10 of the Poisons Standard lists substances of such danger to health as to warrant prohibition of sale, supply and use. The standard specifically states that teeth whitening products containing more than 18 per cent carbamide peroxide or more than six per cent hydrogen peroxide may only be sold, supplied and used by registered dental practitioner2 as part of their dental practice.
Part 3 (Miscellaneous Regulations) of the Poisons Standard makes a recommendation that the states and territories implement regulations which provide controls regarding advertising, notably a prohibition on advertising of any poison listed in schedule 10 of the Poisons Standard. Most states and territories have now adopted this recommendation.
The Australian Competition and Consumer Commission (ACCC) is an independent Commonwealth statutory authority whose role is to enforce the Competition and Consumer Act 2010 and a range of additional legislation promoting competition, fair trading and regulating national infrastructure for the benefit of all Australians.
The ACCC has published a product safety bulletin which provides information for consumers about hydrogen peroxide and carbamide peroxide in do-it-yourself (DIY) teeth whitening products for use at home, including hazards associated with their use. It also helps suppliers of these cosmetic goods to ensure products they supply are safe and comply with the law.
As detailed within the bulletin, the ACCC’s position is that DIY teeth whitening products containing concentrations of more than six per cent hydrogen peroxide or more than 18 per cent carbamide peroxide are unsafe for self administered home use.
Accordingly, dental practitioners cannot supply to patients take-home teeth whiteners above six per cent hydrogen peroxide or more than 18 per cent carbamide peroxide. The Board advises dental practitioners to review the ACCC’s bulletin published on its website for further information.
When using teeth whitening products the Board expects dental practitioners to:
It is an offence under section 121 of the National Law3 to perform a restricted dental act if you are not a registered dental or medical practitioner.
A restricted dental act includes performing any irreversible procedure on the human teeth or jaw or associated structures such as the use of teeth whitening substances identified under schedule 10 of the Poisons Standard (containing more than 18 per cent carbamide peroxide or more than six per cent hydrogen peroxide).
The Scope of practice registration standard and guidelines are part of the Board's broad regulatory framework.
These documents do not refer to specific clinical areas of practice as they need to apply to all dental practitioners across a range of clinical settings to meet the needs of patients.
The Board expects dental practitioners to practise within this regulatory framework at all times including when using teeth whitening products. The Scope of practice registration standard, approved by health ministers in 2014, describes the Board’s requirements of all dental practitioners to practise within the scope of their education, training and competence.
The associated Guidelines for scope of practice include a broad definition of dentistry.
Dental practitioners need to practise within this definition when using teeth whitening products.
The Code of conduct describes the Board’s expectations of what constitutes good practice. Dental practitioners have a duty to make the care of patients their first concern and to practise safely and effectively at all times.
Teeth whitening products should only be used if the treatment can be justified. Informed consent, including financial consent, must be obtained and the risks associated with the treatment, explained to the patient, and documented.
Dental practitioners need to be particularly aware of the patient’s expectations regarding the use of teeth whitening products. Dental practitioners must communicate effectively with the patient to ensure that they are understood and that the patient’s expectations are reasonable.
The Board expects dental practitioners to refer a patient to a suitably trained and qualified:
Any person, including businesses, advertising the use of teeth whitening products must comply with the:
The Board’s Guidelines for advertising of regulated health services also apply.
1 is a compilation of decisions made under section 52D of the Therapeutic Goods Act 1989
2 includes dental specialists
3 The Health Practitioner Regulation National Law, as in force in each state and territory (the National Law).