Therapeutic Goods (Listing) Notice 2014 (No. 2)

Administered by Department of Health, Disability and Ageing

Legislation au F2014L01011 Not in force Legislative Instrument

Select Document

EXPLANATORY STATEMENT

THERAPEUTIC GOODS (LISTING) NOTICE 2014 (NO. 2)

Subsection 9A(5), Therapeutic Goods Act 1989

OUTLINE

Therapeutic Goods (Listing) Notice 2014 (No. 2) (the Listing Notice) is a notice made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).

The Listing Notice has the effect of requiring that therapeutic goods that contain ‘Garcinia gummi-gutta’ (synonym: Garcinia cambogia) as a therapeutically active ingredient, subject to certain conditions, be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods.

The Listing Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments (FRLI).

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 (the TGA) is responsible for administering the Act.

Unless specifically exempted or authorised under the Act, therapeutic goods are required to be included on the Register before being supplied in, imported into, manufactured in or exported from, Australia (sections 19B and 19D of the Act refer). Medicines are either registered or listed on the Register, depending on the ingredients they contain and the therapeutic claims that are being made.

In general, products that contain low risk ingredients are referred to as listed medicines in Australia. Most listed medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines, as they may only contain ingredients that have been approved by the TGA as being of low risk and may only make limited therapeutic claims.

Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations) sets out those therapeutic goods that are required to be included in the part of the Register for listed goods. Part 1 of Schedule 4 does not currently include goods containing ‘Garcinia gummi-gutta’ as a therapeutically active ingredient.

Subsection 9A(5) of the Act authorises the Minister for Health to publish a notice in the Commonwealth of Australia Gazette requiring that specified goods be included in the part of the Register for listed goods. Such notices generally require that goods containing particular ingredients be included in that part of the Register. Once the notice is in effect, persons may apply for the listing on the Register of new therapeutic goods that contain ingredients or substances of the kind set out in the notice.

If Part 1 of Schedule 4 to the Regulations is amended to require goods that are the subject of a subsection 9A(5) notice to be included in the part of the Register for listed goods, the notice ceases to have effect (subsection 9A(6) of the Act).

A person can apply for a new ingredient or substance to be specified in a notice under subsection 9A(5). The TGA evaluates such applications, and the supporting data provided by the applicant, on the basis of safety and quality. The safety-focussed element determines whether the ingredient or substance is of sufficiently low risk to allow its inclusion in listed medicines, and the quality-focussed element characterises the precise and correct nature of the ingredient or substance.

‘Garcinia gummi-gutta’

Garcinia gummi-gutta (synonym: Garcinia cambogia) is a plant from the genus Garcinia, of the family Clusiaceae, that is native to South East Asia and southern India. Currently, Garcinia quaesita is the only Garcinia species permitted for use in listed medicines.

The dried fruit rind of G. gummi-gutta has a long history of use for culinary purposes and in Ayurverdic medicine. In considering the safety of the ingredient, the TGA has noted that a related Garcinia species, that is, G. quaesita and its bioactive component, hydroxycitrate complex extracted from the rind of G. quaesita fruit, are ingredients permitted for use in listed complementary medicines. The TGA has also noted that the United States Food and Drug Administration, and Health Canada allow extracts from the rind of G.gummi-gutta fruit to be used in dietary supplements.

In relation to the quality of G.gummi-gutta, United States Pharmacopeia-National Formulary includes monographs for Garcinia cambogia’ or ‘Powdered Garcinia cambogia’.

To that end, the delegate of the Minister has determined that therapeutic goods containing ‘G.gummi-gutta’ (synonym: G. cambogia) as a therapeutically active ingredient be included in the part of the Register for listed goods, when:

obtained from the rind of the Garcinia gummi-gutta fruit; and
the preparation is for oral use only; and
the preparation does not contain any directions for use for children or pregnant or lactating women.

CONSULTATION

Consultation was not undertaken in relation to the making of the Listing Notice, as the notice is considered to be minor and machinery in nature, with low compliance costs for affected industry. The making of the Notice does not involve any new regulatory steps for industry, but rather provides a basis for products containing this ingredient to access the listing process rather than registration, a significant benefit for sponsors. The Office of Best Practice Regulation (OBPR) has advised that a regulatory impact statement is not required in relation to Listing Notices (OBPR Ref. 14416).

The effect of the Listing Notice is that sponsors wishing to use ‘G. gummi-gutta’ in the formulation of a medicine can list the medicine on the Register rather than registering that medicine. Applications for new registered medicines are fully evaluated by the TGA for quality, safety and efficacy prior to inclusion on the Register, a process that is considerably more expensive and lengthy than the listing process.

In relation to compatibility with human rights, it is considered that the Listing Notice is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, and a Statement of Compatibility setting that out in further detail is set out below.

SUPPLEMENTARY MATERIAL – STATEMENT OF COMPATIBILITY FOR A LEGISLATIVE INSTRUMENT THAT DOES NOT RAISE ANY HUMAN RIGHTS ISSUES

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Therapeutic Goods (Listing) Notice 2014 (No. 2) – ‘Garcinia gummi-gutta’

This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Bill/Legislative Instrument

Therapeutic Goods (Listing) Notice 2014 (No. 2) (the Notice) is a notice made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act). The effect of the Notice is to allow sponsors of orally ingested therapeutic goods containing ‘Garcinia gummi-gutta’ as a therapeutically active ingredient to list, rather than register, those goods in the Australian Register of Therapeutic Goods (the Register) (registration being a considerably more expensive and lengthy process than listing). Once the Notice has commenced, persons can apply to list goods containing this ingredient on the Register.

Human rights implications

This legislative instrument does not engage any of the applicable rights or freedoms.

Conclusion

This legislative instrument is compatible with human rights as it does not raise any human rights issues.

Professor John Skerritt, delegate of the Minister for Health

Overview

The Therapeutic Goods (Listing) Notice 2014 (No. 2) was enacted to address the inclusion of therapeutic goods containing 'Garcinia gummi-gutta' (Garcinia cambogia) as a therapeutically active ingredient in the Australian Register of Therapeutic Goods. This notice was made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989. The primary objective of this notice is to facilitate the listing of such goods on the Register, which is a less cumbersome process than registration, thereby benefitting sponsors by reducing costs and time. This notice was introduced to ensure that these specific goods, when obtained from the rind of the Garcinia gummi-gutta fruit, prepared for oral use only, and not directed for use by children or pregnant or lactating women, are included in the part of the Register for listed goods. The notice was considered minor and machinery in nature, with low compliance costs for industry, and therefore did not require consultation or a regulatory impact statement.

Scope and Application

The Therapeutic Goods (Listing) Notice 2014 (No. 2) is a notice issued by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989. This notice mandates that therapeutic goods containing 'Garcinia gummi-gutta' (synonym: Garcinia cambogia) as a therapeutically active ingredient be included in the part of the Australian Register of Therapeutic Goods for listed goods, subject to specific conditions. This notice is designed to facilitate the listing of these goods rather than the more rigorous registration process, thereby offering significant benefits in terms of cost and time efficiency for sponsors. The Listing Notice applies to therapeutic goods containing 'Garcinia gummi-gutta' obtained from the rind of the fruit, intended for oral use only, and not directed for use by children or pregnant or lactating women. This legislative instrument operates across Australia, given its national scope as a federal measure under the Therapeutic Goods Act 1989. There are no specific exclusions or exemptions outlined in the notice itself, although compliance with the conditions set forth is mandatory for inclusion on the Register. The Act allows for the extension or restriction of the notice's application through subordinate instruments, thereby providing flexibility in managing therapeutic goods based on ongoing assessments of safety and quality. The Therapeutic Goods Act 1989 provides for a national system of controls aimed at ensuring the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia. The Therapeutic Goods Administration (TGA) administers this Act, requiring that therapeutic goods be included on the Australian Register of Therapeutic Goods before being supplied, imported, manufactured, or exported within Australia. The Listing Notice under consideration complements this regulatory framework by specifically addressing the inclusion of 'Garcinia gummi-gutta' in listed medicines, a category considered to be of relatively low risk. This notice ensures that such goods meet the necessary safety and quality standards before being listed, thereby maintaining the integrity of the national regulatory system.

Key Provisions

The Therapeutic Goods (Listing) Notice 2014 (No. 2) (the Listing Notice) is a directive issued under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act). This notice mandates that therapeutic goods containing 'Garcinia gummi-gutta' (synonym: Garcinia cambogia) as an active ingredient be included in the Australian Register of Therapeutic Goods (the Register) for listed goods, provided certain conditions are met. Specifically, these goods must be obtained from the rind of the Garcinia gummi-gutta fruit, intended for oral use only, and must not contain any directions for use in children or pregnant or lactating women (section 2 of the Listing Notice). The Listing Notice came into effect on the day after its registration on the Federal Register of Legislative Instruments (FRLI). Under the Listing Notice, sponsors of therapeutic goods containing 'Garcinia gummi-gutta' can apply to have their products listed in the Register for listed goods, rather than undergoing the more rigorous and costly registration process. This provision is designed to facilitate easier access to the market for products containing this ingredient, provided they meet the specified conditions. The Therapeutic Goods Administration (TGA) is responsible for evaluating applications to ensure compliance with the safety and quality standards outlined in the Listing Notice. Breach of the Listing Notice can result in significant legal consequences. Any therapeutic goods that do not comply with the conditions set out in the Listing Notice, or that are supplied in Australia without being appropriately listed in the Register, could face enforcement actions. Such actions might include fines, product recalls, and other regulatory measures to ensure compliance with the Act. The Therapeutic Goods Act 1989 stipulates penalties for non-compliance, which may include substantial financial penalties and, in severe cases, criminal charges (sections 25 and 33 of the Act). The TGA has the authority to take these actions to enforce the provisions of the Act and ensure the safety and quality of therapeutic goods available in Australia.

Area of Law: Medical Law
Instrument: Notice
Concepts: Definitions & Interpretation; Regulatory Standards; Licensing & Registration

Interactions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.

Legislation content