Commonwealth legislation

Therapeutic Goods (Listing) Notice 2010 (No. 2)

RepealedCTH

This Act has been repealed and is no longer in force. It is retained for historical reference.

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

2/10 complexity

This notice allows Caralluma adscendens var. fimbriata (a succulent plant traditionally used for appetite suppression) to be sold in Australia as a "Listed" medicine.

What this means:

Listed medicines are low-risk health products (like vitamin supplements) that can be sold without the heavy testing required for prescription drugs. They must be entered on the Australian Register of Therapeutic Goods (ARTG).
The catch: Only specific manufacturing methods are permitted. The ingredient must be:
- Sourced only from the dried aerial parts (stems and leaves above ground) of the plant; and
- Extracted using only a hydroethanolic solution (a water and ethanol mix).

Why it matters: This gives supplement manufacturers a legal pathway to sell products containing this specific Indian herb in Australia—commonly marketed for weight management—provided they stick to these exact production rules. The permission is temporary until the regulations are formally updated.

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Current sections

Direct links to the current provisions in Therapeutic Goods (Listing) Notice 2010 (No. 2).

Therapeutic Goods (Listing) Notice 2010 (No. 2)

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Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2010 (No. 2)

I, ROHAN HAMMETT National Manager, Therapeutic Goods Administration, delegate of the Minister for Health and Ageing for the purposes of subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act) and acting under that provision, require the following therapeutic goods to be included in the part of the Australian Register of Therapeutic Goods (the Register) for Listed goods:

preparations, for the purpose of item 3 of Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations), that contain Caralluma adscendens var. fimbriata as a therapeutically active ingredient.

The inclusion of such goods in that part of the Register is subject to the following conditions:

the preparation is derived from the dried aerial parts of Caralluma adscendens var. fimbriata only; and
the preparation is a hydroethanolic extract only.

This Notice commences from the day after it is registered on the Federal Register of Legislative Instruments.

Pursuant to subsection 9A(6) of the Act, this Notice ceases to have effect on the day that amendments to the Regulations come into effect to require inclusion of the therapeutic goods listed in this Notice in the part of the Register for Listed goods.

Dated this 8th day of April 2010

(signed by )

Dr Rohan Hammett

Delegate of the Minister for Health and Ageing

Source text

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

1 Therapeutic Goods (Listing) Notice 2010 (No. 2)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2010 (No. 2)

preparations, for the purpose of item 3 of Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations), that contain Caralluma adscendens var. fimbriata as a therapeutically active ingredient.

The inclusion of such goods in that part of the Register is subject to the following conditions:

the preparation is derived from the dried aerial parts of Caralluma adscendens var. fimbriata only; and
the preparation is a hydroethanolic extract only.

This Notice commences from the day after it is registered on the Federal Register of Legislative Instruments.

Dated this 8th day of April 2010

(signed by )

Dr Rohan Hammett

Delegate of the Minister for Health and Ageing