ADIA is the peak business organisation representing manufacturers and suppliers of dental products. Our vision is for an industry that empowers oral health professionals to advance the health and wellbeing of all Australians...................... — ADIA Strategic Plan

For Professionals — Teeth whitening product regulation

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New regulatory standards for teeth whitening products that came into force on 1 May 2013 have clarified the continuation of general sales status for teeth whitening products containing 6% or less hydrogen peroxide and / or 18% or less carbamide peroxide, as long as they meet the requirements set out in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). Teeth whitening products containing concentrations of hydrogen peroxide and / or carbamide peroxide greater than this are permitted to be dispensed by registered dental professionals to patients as part of their dental practice.

Current regulatory standards —

The regulatory standards for teeth whitening products are set out in the SUSMP (also commonly referred to as the Poisons Standard) that are given effect by the following state and territory government legislation:

Medicines, Poisons and Therapeutic Goods Act (ACT) 2012
Poisons and Therapeutic Goods Act (NSW) 1966
Medicines, Poisons and Therapeutic Goods Act (NT) 2012
Health Act (Qld) 1937
Controlled Substances Act (SA) 1984
Poisons Act (Tas) 1971
Drugs, Poisons and Controlled Substances Act (Vic)1981
Poisons Act (WA) 1964

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It is important to note that these Acts referencing the SUSMP are the only legislation that pertain to the supply of teeth whitening products.

As the SUSMP entries limit dispensing of higher-strength teeth whitening products containing greater than 6% hydrogen peroxide and greater than 18% carbamide peroxide to “registered dental professionals to patients as part of their dental practice”, it is important that professionals dispensing such products be mindful of their obligations under the Health Practitioner Regulation National Law.

What products can be dispensed —

The entries for teeth whitening products containing hydrogen peroxide and carbamide peroxide of 6% or less hydrogen peroxide and 18% or less carbamide peroxide allow general sale (e.g. through supermarkets) of these products. In this respect there is no change to the regulatory controls for these products from the arrangements that existed prior to the updated regulatory standards coming into effect.

From 1 May 2013, teeth whitening products containing concentrations of greater than 6% hydrogen peroxide and / or greater than 18% carbamide peroxide can only be dispensed by registered dental practitioners as part of their dental practice. It is expected that the practical outcome will be that after a patient consultation, a dentist can use both use higher-strength teeth whitening products within their surgery and also dispense patients with take-home kits. It is important to note that the policy on teeth whitening developed by the Dental Board of Australia (DBA) under Section 39 of the Health Practitioner Regulation National Law Act (National Law), as in force in each state and territory, states that teeth whitening products should only be used by a registered dental practitioner with education, training and competence in teeth whitening.

It is envisaged that the dental industry (i.e. product suppliers) is able to sell these products to registered dental practitioners (but not directly to the public) for this purpose.

ACCC Product Recalls —

Under Schedule 2, Section 122 of the Competition and Consumer Act (Cth) 2010, the Assistant Treasurer (as the Minister responsible) has the power to seek a recall of products in circumstances that include where: it appears to the responsible Minister that a reasonably foreseeable use, including misuse, of such goods will or may cause injury to any person; and it appears to the responsible Minister that one or more of the suppliers of goods have not taken satisfactory action to prevent those goods causing injury to any person. Throughout 2011 and 2012 the teeth whitening products supplied by fourteen companies were recalled and a list of these is available at:

www.recalls.gov.au/content/index.phtml/itemId/952835/fromItemId/952831

Notwithstanding the changes to the regulatory standards for teeth whitening products that came into effect on 1 May 2013, it is understood that the earlier recall notices relating to specific products supplied by the fourteen companies remain in effect.

As a point of clarification and to correct a widespread misunderstanding, the Australian Competition and Consumer Commission (ACCC) does not have any legislation that specifically references or creates regulatory standards for teeth whitening products. The ACCC is relying on the definition within the Competition and Consumer Act (Cth) 2010 of what constitutes a “consumer product” which could be interpreted as effectively giving the ACCC responsibility over any product sold to a consumer.

Who can lawfully supply product —

State and territory government legislation permits the sale of teeth whitening products containing 6% or less hydrogen peroxide and / or less than 18% carbamide peroxide as general sales products, as long as they meet the requirements set out in the SUSMP. These include requirements that teeth whitening products containing between 3 and 6% hydrogen peroxide or between 9 and 18% carbamide peroxide to be clearly labelled as a Schedule 5 product. The SUSMP requires prominent warnings about ingestion and contact with skin, including Poisons Information Centre contact details, and the display of “CAUTION” on the front label.

Similarly, state and territory government legislation adopt the provisions of the SUSMP to permit the dispensing of teeth whitening products containing greater than 6% hydrogen peroxide and / or 18% carbamide peroxide by registered dental professionals to patients as part of their dental practice. These Schedule 6 products are required by the SUSMP to also include prominent warnings about ingestion and contact with skin, including Poisons Information Centre contact details, and the display of “POISON” on the front label. Suppliers of dental products are able to sell these higher-strength teeth whitening products to registered dental professionals only.

As at 13 May 2013, the ACCC has advised ADIA that it is still considering its position with respect to the updated SUSMP.

In July 2012 the ACCC published a document entitled Product Safety Bulletin: Safety of do-it-yourself (DIY) teeth whitening products for at home use that provided guidance on the supply of teeth whitening product in the context of the regulatory standards that were in place at the time of publication. This document has become outdated as it is yet to incorporate changes necessary to reflect amendments to, and be consistent with, the SUSMP. Marketplace uncertainty exists as this document provides guidance to “only supply DIY teeth whitening products that comply with the Poisons Standard 2012, including all necessary warnings”, which when read in context of the current poisons legislation would allow registered dental professionals to dispense teeth whitening products containing concentrations of hydrogen peroxide and / or carbamide peroxide greater than 6% hydrogen peroxide and / or 18% carbamide peroxide as part of their dental practice.

It is understood that the ACCC does not have statutory provisions to prevent a registered dental professional from lawfully distributing higher-strength teeth whitening products in accordance with the SUSMP, is accordance with the enabling state and territory legislation (with the exception of those products referenced in the aforementioned recall actions). That is not to say further recall notices could not be issued in the future which may limit such products being dispensed going forward.

The ACCC has advised that it is considering whether it will seek to set aside this regulation and put in place its own requirements; however, this statement was made in 2013 and no subsequent action has been forthcoming.

As the dental industry’s peak representative body and the Australian Government’s primary reference point on matters concerning the regulatory standards for the manufacture, importation and supply of all dental products, ADIA has been working with the ACCC, other departments and agencies to secure reform to the regulatory standards for teeth whitening products. Over the course of the past month ADIA has been in constant communication with the ACCC to provide advice and guidance on the practical application of the revised poisons legislation. There are a number of questions that remain and ADIA will provide updates as it continues its negotiations with government.

Further Information —

If you have an interest in how ADIA seeks to build stronger links between the dental industry, dentists and allied oral healthcare professionals be sure to subscribe to the Twitter feed @AusDental or follow us on Facebook at www.facebook.com/dental.industry. Alternatively, you can contact ADIA national office team responsible for engagement with dental professionals via email at policy@adia.org.au or by telephone on 1300 943 094.

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This information is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated.

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