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.