Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 (50 of 2024)

Schedule 1   Amendment of the Therapeutic Goods Act 1989

Part 3   Advertising relating to vaping goods

Division 1   Main amendments

Therapeutic Goods Act 1989

27   After Part 5-1

Insert:

Part 5-1A - Vaping goods

Division 1 - Preliminary

42DZA This Part not to apply to certain advertisements for exported goods

This Part does not apply to advertisements that are solely for vaping goods that have been exported, or are intended exclusively for export, if the advertisements are not available to consumers in Australia.

42DZB Definitions

In this Part:

generic information , in relation to vaping goods, includes any statement, pictorial representation or design, however made, about the composition, properties or other characteristics of the vaping goods, but does not include:

(a) an advertisement about the goods; or

(b) generic information included in an advertisement about the goods; or

(c) bona fide news.

Division 2 - General provisions about advertising vaping goods

42DZC Authorised advertisements etc.

Secretary may authorise advertising

(1) The Secretary may, by legislative instrument, authorise the advertising, or a class of advertising, of specified vaping goods or a specified class of vaping goods.

Conditions

(4) An authorisation under this section may be subject to conditions specified in the authorisation.

(5) Without limiting subsection (4), conditions in an authorisation of advertising may relate to any of the following:

(a) the nature of the audience to which the advertising is targeted;

(b) the form of the advertising;

(c) the content of the advertising;

(d) representations or information on:

(i) the labels of specified vaping goods or a specified class of vaping goods; or

(ii) the packages in which specified vaping goods or a specified class of vaping goods are contained; or

(iii) any material included with the package in which specified vaping goods or a specified class of vaping goods are contained.

Division 3 - Offences and civil penalty provisions

42DZD Offences - no authorisation or conditions of authorisation not complied with

(1) A person commits an offence if:

(a) the person:

(i) advertises, by any means, vaping goods; or

(ii) causes the advertising, by any means, of vaping goods; and

(b) either:

(i) no authorisation under section 42DZC is in force in relation to the advertising; or

(ii) an authorisation under section 42DZC is in force in relation to the advertising, but the advertising does not include representations or information as specified in the authorisation, or the advertising is not otherwise in accordance with the authorisation, or the advertising does not comply with a condition to which the authorisation is subject.

Penalty: Imprisonment for 7 years or 5,000 penalty units, or both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence of strict liability if:

(a) the person:

(i) advertises, by any means, vaping goods; or

(ii) causes the advertising, by any means, of vaping goods; and

(b) either:

(i) no authorisation under section 42DZC is in force in relation to the advertising; or

(ii) an authorisation under section 42DZC is in force in relation to the advertising, but the advertising does not include representations or information as specified in the authorisation, or the advertising is not otherwise in accordance with the authorisation, or the advertising does not comply with a condition to which the authorisation is subject.

Penalty: 200 penalty units.

Continuing offences

(3) A person who contravenes subsection (1) or (2) commits a separate offence in respect of each day (including a day of a conviction for the offence or any later day) during which the contravention continues.

(4) The maximum penalty for each day that an offence against subsection (1) or (2) continues is 10% of the maximum pecuniary penalty that can be imposed in respect of that offence.

42DZE Civil penalty - no authorisation or conditions of authorisation not complied with

(1) A person contravenes this subsection if:

(a) the person:

(i) advertises, by any means, vaping goods; or

(ii) causes the advertising, by any means, of vaping goods; and

(b) either:

(i) no authorisation under section 42DZC is in force in relation to the advertising; or

(ii) an authorisation under section 42DZC is in force in relation to the advertising, but the advertising does not include representations or information as specified in the authorisation, or the advertising is not otherwise in accordance with the authorisation, or the advertising does not comply with a condition to which the authorisation is subject.

Maximum civil penalty:

(a) for an individual - 7,000 penalty units; and

(b) for a body corporate - 70,000 penalty units.

Continuing contraventions

(2) A person who contravenes subsection (1) commits a separate contravention of that subsection in respect of each day during which the contravention continues (including the day the order under subsection 42Y(2) is made or any later day).

(3) The maximum civil penalty for each day that a contravention against subsection (1) continues is 10% of the maximum civil penalty that can be imposed in respect of the contravention.

Division 4 - Secretary may require information or documents

42DZF Secretary may require information or documents

Advertisements

(1) The Secretary may, by written notice given to a person apparently responsible for advertising vaping goods, or for causing the advertising of vaping goods, require the person to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to the advertisement.

Generic information

(2) The Secretary may, by written notice given to a person apparently responsible for disseminating, or for causing the disseminating of, generic information in relation to vaping goods to the public or a section of the public, require the person to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to the dissemination.

Manner of compliance

(3) The person must give the information, or produce the documents, to the Secretary:

(a) within the period, of not less than 14 days after the day the notice is given, specified in the notice or within such longer period as the Secretary allows; and

(b) in the form specified in the notice.

Note: A person may commit an offence under section 42DZG for failing to comply with the notice or giving false or misleading information or documents and may be liable to a civil penalty under section 42DZH for giving false or misleading information or documents.

(4) The form may require or permit the information to be given, or the documents to be produced, in accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

Notice not a legislative instrument

(5) A notice under subsection (1) or (2) is not a legislative instrument.

42DZG Offences - failing to comply with a notice etc.

(1) A person commits an offence if:

(a) the person is given a notice under subsection 42DZF(1) or (2); and

(b) the person fails to comply with the notice.

Penalty: 500 penalty units.

(2) A person commits an offence of strict liability if:

(a) the person is given a notice under subsection 42DZF(1) or (2); and

(b) the person fails to comply with the notice.

Penalty: 100 penalty units.

(3) A person commits an offence if:

(a) the person is given a notice under subsection 42DZF(1) or (2); and

(b) the person gives information or produces a document in compliance or purported compliance with the notice; and

(c) the information or document is false or misleading in a material particular.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.

(4) A person commits an offence of strict liability if:

(a) the person is given a notice under subsection 42DZF(1) or (2); and

(b) the person gives information or produces a document in compliance or purported compliance with the notice; and

(c) the information or document is false or misleading in a material particular.

Penalty: 100 penalty units.

42DZH Civil penalty - giving false or misleading information or document in compliance with a notice

A person contravenes this section if:

(a) the person is given a notice under subsection 42DZF(1) or (2); and

(b) the person gives information or produces a document in compliance or purported compliance with the notice; and

(c) the information or document is false or misleading in a material particular.

Maximum civil penalty:

(a) for an individual - 5,000 penalty units; and

(b) for a body corporate - 50,000 penalty units.

42DZJ Self-incrimination

(1) A person is not excused from giving information or producing a document under section 42DZF on the ground that the information or the production of the document might tend to incriminate the person or expose the person to a penalty.

(2) However, in the case of an individual:

(a) the information given or the document produced; and

(b) giving the information or producing the document; and

(c) any information, document or thing obtained as a direct or indirect consequence of giving the information or producing the document;

are not admissible in evidence against the individual:

(d) in criminal proceedings, except proceedings for an offence against subsection 42DZG(3) or (4); or

(e) in civil proceedings, except proceedings under section 42Y for a contravention of section 42DZH.

Division 5 - Directions about advertisements or generic information

42DZK Directions about advertisements or generic information

Advertisements

(1) If, in relation to the advertising of vaping goods, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for advertising the vaping goods, or for causing the advertising of the vaping goods, to do one or more of the following:

(a) cease the advertisement;

(b) make a retraction;

(c) make a correction;

(d) recover any advertisement that is still in circulation;

(e) destroy the advertisement;

(f) cease making a particular claim or representation made by the advertisement.

Generic information

(2) If, in relation to the dissemination of generic information in relation to vaping goods to the public or a section of the public, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for the dissemination, or for causing the dissemination, to do one or more of the following:

(a) withdraw the generic information;

(b) make a retraction;

(c) make a correction;

(d) recover any generic information that is still in circulation;

(e) destroy the generic information;

(f) cease making a particular claim or representation made by the generic information.

Conditions

(3) A direction under subsection (1) or (2) may be subject to conditions specified in the direction.

(4) Without limiting subsection (3), the conditions may relate to one or more of the following:

(a) the period for doing a thing the subject of the direction;

(b) in relation to the making of a retraction or correction - either or both of the following:

(i) the form and manner of the retraction or correction;

(ii) the period for which the retraction or correction must be made publicly available;

(c) the reporting to the Secretary of compliance with the direction.

Direction not a legislative instrument

(5) A direction under subsection (1) or (2) is not a legislative instrument.

Publication

(6) As soon as practicable after giving a direction under subsection (1) or (2), the Secretary must cause the direction to be published on the Department's website.

42DZL Offences - contravening direction under section 42DZK

(1) A person commits an offence if:

(a) the Secretary has given a direction to the person under subsection 42DZK(1) or (2) in relation to vaping goods; and

(b) the person does an act or omits to do an act; and

(c) the act or omission contravenes the direction or a condition of the direction; and

(d) either:

(i) the use of the vaping goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or

(ii) the use of the vaping goods, if the vaping goods were used, would result in, or would be likely to result in, harm or injury to any person; and

(e) the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because of the contravention.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (2) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the Secretary has given a direction to the person under subsection 42DZK(1) or (2); and

(b) the person does an act or omits to do an act; and

(c) the act or omission contravenes the direction or a condition of the direction.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.

(3) A person commits an offence of strict liability if:

(a) the Secretary has given a direction to the person under subsection 42DZK(1) or (2); and

(b) the person does an act or omits to do an act; and

(c) the act or omission contravenes the direction or a condition of the direction.

Penalty: 100 penalty units.

42DZM Civil penalty - contravening direction under section 42DZK

A person contravenes this section if:

(a) the Secretary has given a direction to the person under subsection 42DZK(1) or (2); and

(b) the person does an act or omits to do an act; and

(c) the act or omission contravenes the direction or a condition of the direction.

Maximum civil penalty:

(a) for an individual - 5,000 penalty units; and

(b) for a body corporate - 50,000 penalty units.

Division 6 - Public warning notices

42DZN Secretary may issue a public warning notice

(1) The Secretary may issue to the public a written notice containing a warning about vaping goods if:

(a) the Secretary reasonably suspects that there has been a contravention of this Act or the regulations in relation to:

(i) the advertising of the vaping goods; or

(ii) the dissemination of generic information in relation to the vaping goods to the public or a section of the public; and

(b) the Secretary is satisfied that it is in the public interest to issue the notice.

(2) If:

(a) the Secretary has given a person a notice (the substantiation notice ) under subsection 42DZF(1) or (2); and

(b) the person fails to comply with the substantiation notice; and

(c) the Secretary is satisfied that it is in the public interest to issue a notice under this subsection;

the Secretary may issue to the public a written notice containing a warning that the person has failed to comply with the substantiation notice, and specifying the matter to which the substantiation notice related.

(3) Subsection (2) does not limit subsection (1).

(4) A notice under this section is not a legislative instrument.