EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2005 (No 5)
Citric acid anhydrous and citric acid monohydrate
Section 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2005 (No. 5) (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 citric acid anhydrous and citric acid monohydrate as active ingredients in low risk (Listed) complementary medicines.
The Listing Notice takes effect on the day after it is 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 complementary medicines.
In order to facilitate the approval of new Listable substances, subsection 9A(5) of the Act allows the Minister for Health and Ageing to publish a Listing Notice permitting the use of particular substances in Listed medicines and to place conditions subject to which such goods may be included in the ARTG.
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.
Both citric acid anhydrous and citric acid monohydrate have been permitted for use as non-active (excipient) ingredients in Listed medicines for many years. They are also included as active ingredients in a number of Registered medicines entered on the Australian Register of Therapeutic Goods.
Citric acid is used extensively in foods such as soft drinks. A typical expected daily dietary intake is around 300 milligrams per kilogram of body weight per day. A literature-based review found that citric acid did not result in adverse effects at the upper end of doses experienced in everyday use (around 500 milligrams per kilogram of body weight per day).
CONSULTATION
No consultation on the approval of these substances was undertaken. Consultation was not considered necessary because the TGA has conducted a safety review of the substances and concluded that they are suitable for use in low risk complementary medicines without restriction.
REGULATION IMPACT STATEMENT
No Regulation Impact Statement is necessary for Listing Notice No. 5 as:
- the regulation change is minor and machinery in nature; and
- the regulation change benefits the complementary medicines industry by facilitating the approval of new complementary medicine substances prior to formal inclusion in Schedule 4 of the Therapeutic Goods Regulations 1990.
Overview
The Therapeutic Goods (Listing) Notice 2005 (No. 5), enacted under the Therapeutic Goods Act 1989, addresses the need to facilitate the approval and use of certain substances in low-risk complementary medicines. This legislation was introduced by the Minister for Health and Ageing, acting through the delegate, to enable the inclusion of citric acid anhydrous and citric acid monohydrate as active ingredients in Listed complementary medicines. The primary objective of this Notice is to streamline the process for approving substances for use in complementary medicines, thereby supporting the complementary medicines industry. The Therapeutic Goods Administration (TGA) administers the Act and ensures that therapeutic goods meet quality, safety, efficacy, and timely availability standards before they can be supplied in Australia. The Notice is intended to have a minor regulatory impact, benefiting the complementary medicines sector by expediting the approval process for new substances before they are formally included in Schedule 4 of the Therapeutic Goods Regulations 1990.
Scope and Application
The Therapeutic Goods (Listing) Notice 2005 (No. 5) is a regulatory instrument made under the Therapeutic Goods Act 1989, which governs the quality, safety, efficacy, and availability of therapeutic goods in Australia. This Notice specifically allows the use of citric acid anhydrous and citric acid monohydrate as active ingredients in low-risk complementary medicines, facilitating their inclusion in the Australian Register of Therapeutic Goods (ARTG). The Notice applies to entities that manufacture, supply, import, or export therapeutic goods in Australia, particularly those involved in the production of complementary medicines. It is relevant to substances used in Listed medicines, which are typically of low risk and include products such as vitamins, minerals, and herbal supplements. The Notice is applicable nationwide as it pertains to the national system established by the Therapeutic Goods Act 1989. The Therapeutic Goods Administration (TGA) is responsible for administering the Act and ensuring compliance. The Notice does not explicitly state any exclusions or exemptions, but the suitability of citric acid anhydrous and citric acid monohydrate is based on a literature-based safety review conducted by the TGA. The Notice can be extended or restricted through subsequent amendments to Schedule 4 of the Therapeutic Goods Regulations 1990.
Key Provisions
The Therapeutic Goods (Listing) Notice 2005 (No. 5) (section 9A(5) of the Therapeutic Goods Act 1989) authorises the use of citric acid anhydrous and citric acid monohydrate as active ingredients in low risk complementary medicines. This notice is instrumental in expediting the process of approving substances for use in such medicines, prior to their formal inclusion in Schedule 4 of the Therapeutic Goods Regulations 1990. The Listing Notice becomes effective the day after it is registered on the Federal Register of Legislative Instruments.
Entities and parties governed by this Act must ensure that any complementary medicines containing citric acid anhydrous or citric acid monohydrate as active ingredients are included in the Australian Register of Therapeutic Goods (ARTG). The Therapeutic Goods Administration (TGA) is responsible for the administration of this Act and ensuring compliance with the requirements for the quality, safety, efficacy, and timely availability of therapeutic goods in Australia. The Listing Notice imposes a condition that such medicines may only contain ingredients that have been approved by the TGA and may only make certain therapeutic claims.
Failure to comply with the requirements of the Therapeutic Goods Act 1989 and the Therapeutic Goods (Listing) Notice 2005 (No. 5) may result in civil or criminal penalties. The precise consequences of non-compliance depend on the nature and severity of the breach. The Therapeutic Goods Act 1989 includes provisions for both civil and criminal penalties for breaches, including fines and imprisonment, although the specific penalties are not detailed in the Explanatory Statement. The TGA enforces the Act and has the authority to take appropriate action against entities or individuals found in breach of the legislative provisions.