EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods (Listing) Notice 2010 (No. 3)
Wheat dextrin
OUTLINE
Therapeutic Goods (Listing) Notice 2010 (No. 3) (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 has the effect of permitting the use of ‘Wheat dextrin’ as a therapeutically active ingredient in listed medicines for oral use, subject to specified conditions.
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 in the Australian Register of Therapeutic Goods (the Register) before being supplied in, imported into, manufactured in or exported from Australia (sections 19B and 19D of the Act). Medicines are registered or listed in 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 of 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 medicines. At present, Part 1 of Schedule 4 of the Regulations does not cover oral preparations that contain ‘Wheat dextrin’ as a therapeutically active ingredient (subject to the specified condition).
Subsection 9A(5) of the Act authorises the Minister for Health and Ageing to publish a notice in the Commonwealth of Australia Gazette, requiring specified goods to be included in the part of the Register for listed goods. Such notices generally require that goods containing particular ingredients be included in the part of the Register for listed goods. This mechanism permits the timely approval of new listable therapeutic goods containing particular ingredients prior to the inclusion of those therapeutic goods in Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations).
Under subsection 9A(6) of the Act, if the Regulations are amended to require goods that are the subject of a listing notice (i.e. goods noted in a listing notice as containing a particular ingredient or ingredients) be included in the part of the Register for listed goods, that listing notice ceases to have effect.
Wheat dextrin
‘Wheat dextrin’ is a purified component of dextrin produced from wheat starch. The resulting substance consists of a mixture of glucose polymers with a narrow molecular weight range.
‘Wheat dextrin’ is used in foods in many countries (marketed in Australia as a dietary fibre supplement).
Therapeutically, dextrins are often used as an oral dietary supplement, as a tablet and capsule diluent, and as a binding, suspending, and viscosity-increasing agent.
Under subsection 7(1) of the Act, where the Secretary is satisfied that particular goods are therapeutic goods, the Secretary may publish an order in the Gazette declaring that the goods are therapeutic goods. The Order that Goods are Therapeutic Goods No. 1 of 1999 declares that products containing fibre in capsule, tablet or pill form are, for the purposes of the Act, therapeutic goods.
The delegate of the Minister made the Listing Notice, a legislative instrument for the purposes of the Legislative Instrument Act 2003, to provide for ‘Wheat dextrin’ to be used as an ingredient in oral listed medicines in capsule, tablet or pill form.
Draft Compositional Guidelines are prepared by the TGA and intended to set out the standards and requirements for the specific forms or types of substances for use in listed medicines where there is no monograph in an accepted standard.
The TGA has prepared the draft Compositional Guideline in relation to ‘Wheat dextrin’, and this will be available on the TGA’s Internet site (www.tga.gov.au) for consultation for six months following the registration of the Listing Notice on the FRLI.
CONSULTATION
The listing of the ingredient ‘Wheat dextrin’ as a therapeutically active ingredient in oral listed medicines (subject to the specified condition) is minor and machinery in nature. The application to make ‘Wheat dextrin’ available for use as a therapeutically active ingredient in oral listed medicines (subject to the specified condition) was not referred to an external evaluation committee. Such advice was not considered necessary as no apparent safety concerns were raised from the evaluation of the available relevant toxicity data. Moreover, it is noted ‘wheat dextrin’ is a purified component of the traditionally used food ingredient dextrin.
REGULATION IMPACT STATEMENT
No Regulation Impact Statement is necessary in relation to the Listing Notice as the listing of the ingredient ‘Wheat dextrin’ as a therapeutically active ingredient in oral listed medicines (subject to the specified condition) is minor and machinery in nature with no or low compliance costs and impact on business, individuals or the economy.