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08 Feb 2013 | Press Release

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New Laws On Teeth Whitening Products End Confusion

Regulatory Affairs TGA Whitening Teeth whitening

Regulatory changes announced today will permit continued over-the-counter sales of medium strength teeth whitening products and now also permit the sale of higher-strength products solely by registered dental practitioners as part of their dental practice.


The decision brings to a conclusion year-long debate over regulations governing the supply of teeth whitening products in Australia and is supported by the Australian Dental Industry Association (ADIA), the representative body for suppliers of quality dental products.

"This decision is welcomed by ADIA. It ends the confusion that has existed over which teeth whitening products can be sold in Australia," said Troy Williams, ADIA Chief Executive Officer.

The new laws that come into force on 1 May 2013 permit over-the-counter sales of teeth whitening products containing 6% or less hydrogen peroxide and 18% or less carbamide peroxide, in this respect there is no change from current arrangements.

The major change is that from 1 May 2013 teeth whitening products containing concentrations of hydrogen peroxide or carbamide peroxide greater than this must be supplied solely by registered dental practitioners as part of their dental practice. The practical outcome is that after a patient consultation, a dentist can both use higher-strength teeth whitening products within their surgery and also supply patients with take home kits.

"This is a sensible decision that enables appropriate patient access to teeth whitening products and puts in place proper measures to ensure patient safety," Mr Williams said.

The safeguard that limits supply of higher-strength teeth whitening products came about after successful lobbying by ADIA.

"Ultimately, the decision whether or not to supply these higher-strength teeth whitening kits to patients rests on the professional judgment of registered dental practitioners, and their commitment to safe, high quality professional oral care," Mr Williams said.

Reflecting upon the framework in which the new regulatory standards were created, Mr Williams stated it was pleasing the all views were taken into account.

"Dentists, suppliers and other stakeholders had different views and each group was afforded ample opportunity to tender these for consideration. The decision announced today reflects a balanced, evidence-based approach and is one we endorse," Mr Williams said.

According to ADIA, the outcome reflects the Association's support for a regulatory framework for dental product that is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden.

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