EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2012 (NO. 5)
Caffeine
Subsection 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2012 (No. 5) (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 ‘caffeine’ as a therapeutically active ingredient and that are presented as oral preparations, 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). Medicines are 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 that are oral presentations containing ‘caffeine’ 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.
CAFFEINE
Caffeine is a natural constituent of foods such as tea, coffee and chocolate, which are available throughout the world. In Australia, caffeine is present in many herbs currently used in listed medicines, and also as an ingredient in some registered medicines.
Australian adults have been estimated to have an average caffeine intake of approximately 232 mg/person/day from all sources. The use of caffeine specifically as an active ingredient at a daily dose of 100 mg or less in oral listed medicines, for the adult population, would not be expected to add significantly to its current acceptable level of intake as a food component or medicine component and hence is not considered to raise any additional safety concerns.
One of the conditions on the use of purified caffeine in oral listed medicines is that it may only be formulated in a medicine that contains complementary medicine active ingredients. These ingredients are described in Schedule 14 to the Regulations.
The quality of caffeine is assured by mandatory compliance with the monograph in either the British Pharmacopeia or the United States Pharmacopeia.
To that end, the delegate of the Minister has determined that therapeutic goods containing caffeine as a therapeutically active ingredient be included in the part of the Register for listed goods, when such goods are oral preparations, when the preparations contain not more than 100 mg of the active ingredient ‘caffeine’ per daily dose (this condition will not apply to overall caffeine levels, as other ingredients in a relevant listed medicine may also contain caffeine), are for use in adults only and are restricted to products consisting principally of one or more designated active ingredients prescribed in Schedule 14 to the Regulations.
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 effect of this Listing Notice is that sponsors wishing to use caffeine 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.
The Office of Best Practice Regulation (OBPR) has confirmed that a regulatory impact statement was not required in relation to the Listing Notice (OBPR ref. 14416).
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 attached.
ATTACHMENTS
1. Statement of compatibility for a legislative instrument that does not raise any human rights issues (Therapeutic Goods (Listing) Notice 2012 (No.5) – Caffeine).