EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2005 (No. 6)
Sodium monofluorophosphate
Section 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2005 (No. 6) (the Listing Notice) is a Notice made by the delegate of the Minister for Health and Ageing under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).
The Listing Notice permits the use of sodium monofluorophosphate (SMFP) as an active ingredient in low risk (Listed) complementary medicines, provided:
- the preparation includes at least one other therapeutically active Listable ingredient;
- the concentration of the fluoride ion is not more than 1000 mg/kg;
- the substance is for use only in pastes, powders or gels for the cleaning of teeth; and
- claims in relation to fluoride content are restricted to those relating to improvements in oral hygiene or the use of fluoride for the prevention of tooth decay.
The Listing Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments.
BACKGROUND
The Act provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (TGA) is responsible for administering the Act.
Unless specifically exempted under the Act, therapeutic goods are required to be included in the Australian Register of Therapeutic Goods (ARTG) before being supplied in, imported into, manufactured in, or exported from Australia (subsection 20(1) of the Act). Medicines are Registered or Listed in the ARTG, depending on the ingredients they contain and the therapeutic claims that are being made.
In Australia, products such as vitamins, minerals, nutritional supplements and herbal, aromatherapy and homoeopathic products are regulated as ‘complementary’ medicines. Most, but not all, complementary medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines, and are Listed in the ARTG. Listed medicines may only contain ingredients that have been approved by the TGA as being of low risk and may only make certain therapeutic claims.
Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out those therapeutic goods that are required to be included in the part of the ARTG for Listed medicines.
In order to facilitate the timely approval of new Listable substances, subsection 9A(5) of the Act allows the Minister for Health and Ageing to publish a Listing Notice that has the effect of permitting the use of particular substances in Listed medicines subject to any specified conditions.
Pursuant to subsection 9A(6) of the Act, when Schedule 4 of the Regulations is amended to include reference to a substance that has been the subject of Listing Notice, the Listing Notice ceases to have effect.
SMFP is a source of fluoride that is widely used in toothpaste products at up to 1000 mg/kg without evidence of safety concerns. A safety review by the TGA did not reveal any safety concerns with this source of fluoride that would preclude the use of this substance in Listed medicines provided that:
- the concentration of the fluoride ion is not more than 1000 mg/kg;
- the substance is for use only in pastes, powders or gels for the cleaning of teeth; and
- claims in relation to fluoride content are restricted to those relating to improvements in oral hygiene or the use of fluoride for the prevention of tooth decay.
CONSULTATION
No consultation on the approval of this substance was undertaken. Consultation was not considered necessary because the TGA has conducted a safety review of the substance and concluded that it is suitable for use in low risk complementary medicines, with particular restrictions.
REGULATION IMPACT STATEMENT
No Regulation Impact Statement is necessary in relation to the Listing Notice as the regulation change is minor and machinery in nature.