EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2008 (No. 1)
Sodium fluoride
Section 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2008 (No. 1) (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 fluoride as an active ingredient in Listed medicines for oral use with certain conditions.
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 or authorised 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 (section 19B and 19C 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.
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. Part 3 of Schedule 4 is for minerals and their salts that are for use in 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.
Sodium fluoride is a source of fluoride that is widely used in toothpaste products at concentrations of fluoride ion of up to 1 000 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 1 000 mg/kg;
- the substance is for use only in pastes, powders or gels for dental hygiene; and
- claims in relation to fluoride content are restricted to those relating to improvements in dental hygiene or the use of fluoride for the prevention of tooth decay.
At levels above 1 000 mg/kg, fluoride is in Schedule 4 of the Standard for the Uniform Scheduling of Drugs and Poisons and is therefore available only on a doctor’s prescription.
Sodium fluoride is the subject of monograph of the British Pharmacopoeia and its safety profile is well established in this application.
CONSULTATION
No consultation is necessary in relation to the Listing Notice as the regulation change is minor and machinery in nature.
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.
Overview
The Therapeutic Goods (Listing) Notice 2008 (No. 1) was enacted under the Therapeutic Goods Act 1989 to facilitate the inclusion of specific substances in Listed medicines, thereby ensuring they meet the necessary safety and efficacy standards. This Notice was issued by the delegate of the Minister for Health and Ageing, allowing the use of Sodium fluoride as an active ingredient in Listed medicines for oral use, subject to certain conditions. This legislative measure was intended to streamline the approval process for substances that pose no significant safety risk, provided they adhere to the specified concentration limits and intended use. The Notice came into effect immediately after its registration on the Federal Register of Legislative Instruments, providing a clear framework for the inclusion of Sodium fluoride in dental hygiene products within Australia.
Scope and Application
The Therapeutic Goods (Listing) Notice 2008 (No. 1) pertains to the use of Sodium fluoride as an active ingredient in Listed medicines for oral use, which are regulated under the Therapeutic Goods Act 1989. This Notice, made by the delegate of the Minister for Health and Ageing, allows for the inclusion of Sodium fluoride in Listed medicines under specific conditions, primarily focusing on its concentration and intended use. The Notice applies to entities and individuals involved in the supply, importation, manufacture, or export of therapeutic goods within Australia, as well as to the therapeutic goods themselves. The conditions set forth in the Notice include limiting the fluoride ion concentration to not more than 1000 mg/kg, restricting its use to dental hygiene products such as pastes, powders, or gels, and confining claims to improvements in dental hygiene or the prevention of tooth decay. This Notice extends across Australia, reflecting the national scope of the Therapeutic Goods Act 1989, and it applies to all Listed medicines that meet the specified conditions. The Notice does not specify exclusions or exemptions but implicitly excludes fluoride concentrations above 1000 mg/kg, which are regulated differently under the Standard for the Uniform Scheduling of Drugs and Poisons. The application of the Notice may be further detailed or adjusted through subordinate instruments, such as amendments to the Therapeutic Goods Regulations 1990.
Key Provisions
The Therapeutic Goods (Listing) Notice 2008 (No. 1) under section 9A(5) of the Therapeutic Goods Act 1989 allows for the use of Sodium fluoride as an active ingredient in Listed medicines for oral use, subject to specific conditions. This Notice permits the use of Sodium fluoride in dental hygiene products such as pastes, powders, or gels, provided the fluoride ion concentration does not exceed 1000 mg/kg and the therapeutic claims are limited to improvements in dental hygiene or prevention of tooth decay.
The Notice imposes several obligations on the parties it governs. Firstly, any therapeutic goods containing Sodium fluoride must comply with the specified concentration limit of 1000 mg/kg. Secondly, the substances can only be used in products intended for oral dental hygiene purposes. Thirdly, the claims made about these products must strictly adhere to the approved therapeutic uses, which are limited to dental hygiene improvements and prevention of tooth decay.
Failure to comply with the conditions set out in the Therapeutic Goods (Listing) Notice 2008 (No. 1) can result in significant legal consequences. While the Notice itself does not explicitly outline specific penalties, the Therapeutic Goods Act 1989 provides a framework for enforcement. Under this Act, breaches of therapeutic goods regulations can lead to civil and criminal penalties. Civil penalties may include fines, while criminal penalties can include imprisonment. The exact penalties depend on the severity and frequency of the breach, as well as other relevant factors that a court would consider when imposing a sentence.