EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2006 (No. 1)
Undaria pinnatifida powder
Section 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2006 (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 the brown seaweed Undaria pinnatifida as an active ingredient in low risk (Listed) complementary medicines for oral use.
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.
U. pinnatifida is a brown marine alga, native to temperate coastal regions of Japan, Korea and China. It has spread, most likely via ship ballast water, to France, New Zealand and Australia, where it is considered to be a marine pest.
U. pinnatifida has been an important part of the diet in Japan, Korea and China for centuries, in both raw and cooked forms. It also has a long history of use in traditional medicines in these countries. In Japan, U. pinnatifida is used for hypertension, atherosclerosis, liver complaints and cancer.
U. pinnatifida is also one of three species of brown algae which may be used in the traditional Chinese medicine “Kunbu”, which is used for a range of conditions, including goitre, tumour, oedema, testicular pain and swelling, beri-beri, urinary infection, sore throat and scrofula (a tuberculous infection of the skin and neck).
The long history of use of U. pinnatifida as a food and a traditional medicine supported its safety and suitability for use as an active ingredient in Listed medicines for oral use.
CONSULTATION
This substance has been reviewed by the Complementary Medicines Evaluation Committee (CMEC), which is comprised of some of Australia’s leading experts on complementary medicines. CMEC provides scientific and policy advice to the TGA relating to controls on the supply and use of complementary medicines, with particular reference to safety, quality and where appropriate, efficacy.
CMEC recommended that the whole dried plant of U. pinnatifida only, minus the holdfast (being the organ or structure by which the algae attaches itself to rocks or other hard substances), is suitable for use as an active ingredient in Listed medicines for oral use.
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.