{"id":"F2024L00844","name":"Therapeutic Goods (Vaping Goods—Advertising) Authorisation 2024","slug":"therapeutic-goods-vaping-goods-advertising-authorisation-2024","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442483,"registerId":"F2024L00844-fast-fetch-1775957469761","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Vaping Goods—Advertising) Authorisation 2024","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n![Commonwealth Coat of Arms of Australia](image.001.jpeg)\n\n \n\nTherapeutic Goods (Vaping Goods—Advertising) Authorisation 2024\n\nI, Nicholas Henderson, as delegate of the Secretary of the Department of Health and Aged Care, make the following authorisation.\n\nDated 30 June 2024\n\nNicholas Henderson\n\nActing Deputy Secretary  Health Products Regulation Group  Department of Health and Aged Care\n\n \n\n \n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Authorisation\n\nSchedule 1—Authorisation\n\nPart 1—Notified vaping goods\n\nPart 2—Medicinal cannabis vaping goods\n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Vaping Goods—Advertising) Authorisation 2024.\n\n2  Commencement\n\n (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.\n\n \n\n- Commencement information\n- Column 1 Column 2 Column 3\n- Provisions Commencement Date/Details\n- 1. The whole of this instrument At the same time as Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.However, this instrument does not commence at all if the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 does not commence.\n\n\nNote:  This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.\n\n (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.\n\n3  Authority\n\n  This instrument is made under section 42DZC of the Therapeutic Goods Act 1989.\n\n4  Definitions\n\nNote: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n(a) advertise;\n\n(b) essential principles;\n\n(c) indications;\n\n(d) label;\n\n(e) medical practitioner;\n\n(f) nurse practitioner;\n\n(g) pharmacist;\n\n(h) sponsor;\n\n(i) State;\n\n(j) therapeutic goods;\n\n(k) Therapeutic Goods Advertising Code;\n\n(l) vaping goods;\n\n(l) vaping substance.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act.\n\nintended purpose has the same meaning as in the MD Regulations.\n\nCommonwealth health campaign means a campaign about a public health matter that is conducted, approved or funded by the Commonwealth.\n\nmedicinal cannabis product has the same meaning as in the Regulations.\n\nmedicinal cannabis vaping goods means one or more of the following:\n\n (a) a therapeutic cannabis vaping good;\n\n (b) a vaping substance that is a medicinal cannabis product or a medicine that contains synthetic cannabis.\n\nMD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.\n\nMDSO means the Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023.\n\nNote: The MDSO is a legislative instrument published on the Federal Register of Legislation at www.legislation.gov.au.\n\nnotification ID number means the number given to the sponsor by the TGA in relation to a sponsor notice.\n\nnotified vaping goods means one or more vaping goods that are:\n\n(a)    exempt under:\n\n (i) item 15 in the table in Schedule 5A to the TG Regulations, in relation to which the sponsor has given a sponsor notice; or\n\n (ii) item 2.17 in the table of Part 2 in Schedule 4 to the MD Regulations, in relation to which the sponsor has given a sponsor notice; and\n\n (b) not the subject of a determination by the Secretary, published on the Department’s website, that the supply of the goods be stopped or should cease because the Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not comply with a standard applicable to the goods.\n\nprohibited representation means a representation mentioned in subsection 42DJ(1) of the Act.\n\nrestricted representation means a representation mentioned in section 42DD of the Act.\n\nsponsor notice means a notice given to the Secretary in compliance with:\n\n (a) item 15 in the table in Schedule 5A to TG Regulations; or\n\n (b) item 2.17 in the table in Part 2 of Schedule 4 to the MD Regulations.\n\nState health campaign means a campaign about a public health matter that is conducted, approved, or funded by a State.\n\nNote: State is defined in subsection 3(1) of the Act as including the Australian Capital Territory and the Northern Territory.\n\nTGO 93 means the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017.\n\nNote: TGO93 is a legislative instrument published on the Federal Register of Legislation at www.legislation.gov.au.\n\nTGO 110 means the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021.\n\nNote: TGO 110 is a legislative instrument published on the Federal Register of Legislation at www.legislation.gov.au.\n\ntherapeutic cannabis vaping good has the same meaning as in the MD Regulations.\n\nTherapeutic Goods Administration, or TGA has the same meaning as in the TG Regulations.\n\nTG Regulations means the Therapeutic Goods Regulations 1990.\n\n5  Authorisation\n\n  For section 42DZC of the Act, in relation to each item in the tables in Parts 1 and 2 of Schedule 1, the advertising, or class of advertising, specified in column 2, of the vaping goods specified in column 3, is authorised, subject to the conditions (if any) specified in column 4.\n\n\n\n\nSchedule 1—Authorisation\n\nNote: See section 5.\n\nPart 1—Notified vaping goods\n\n \n\n- Authorised advertising\n- Column 1 Column 2 Column 3 Column 4\n- Item Advertising Vaping goods Conditions\n- 1 advertising that is:(a) on the label of the vaping goods; or(b) on the package in which the vaping goods are contained; or(c) on any material included with the package in which the vaping goods are contained notified vaping goods the advertising must:(a) comply with the requirements specified in all of the following, as applicable to the vaping goods:(i) TGO 110;(ii) the MDSO;(iii) the essential principles; and(b) comply with the requirements for therapeutic goods specified in Part 3 of the Therapeutic Goods Advertising Code as if that Part applied to the vaping goods; and(c) not contain a prohibited representation or a restricted representation, as if one or more of those representations applied to the vaping goods\n- 2 advertising that is directed exclusively to one or more of the following persons:(a) a medical practitioner;(b) a nurse practitioner;(c) a pharmacist;(d) a practice manager or purchasing officer for a person mentioned in paragraphs (a) to (c) notified vaping goods the advertising must:(a) only contain representations or information relating to all of the following:(i) the availability and price of the vaping goods;(ii) information necessary for the safe and effective use of the vaping goods;(iii) information about the vaping goods, including the indications or intended purposes, ingredients, formulation, composition, design specification or presentation; and(b) comply with the requirements for therapeutic goods specified in Part 3 of the Therapeutic Goods Advertising Code, as if that Part applied to the vaping goods; and(c) contain the notification ID number and the indications or intended purposes; and(d) not be inconsistent with the information provided in the sponsor notice for the vaping goods; and(e) not be promoted at educational, scientific, trade or social events; and(f) not offer any personal payments, gifts, price discounts, incentives, or commissions, in exchange for recommending or supplying the vaping goods; and(g) not contain or consist of samples, or an offer of samples, of the vaping goods that are intended to be provided to a patient; and(h) not contain testimonials or endorsements about the vaping goods; and(i) not contain a prohibited representation or a restricted representation, as if one or more of those representations applied to the vaping goods\n- 3 advertising directed exclusively to and between persons who are engaged in the business of wholesale supply and retail supply of the vaping goods in accordance with:(a) paragraph (h) of item 15 of Schedule 5A to the TG Regulations; or(b) paragraph (g) of item 2.17 of Part 2 of Schedule 4 to the MD Regulations notified vaping goods the advertising must:(a) only contain representations or information relating to all of the following:(i) the availability and price of the vaping goods;(ii) information necessary for the safe and effective use of the vaping goods;(iii) information about the vaping goods, including the indications or intended purposes, ingredients, formulation, composition, design specification or presentation; and(b) comply with the requirements for therapeutic goods specified in Part 3 of the Therapeutic Goods Advertising Code, as if that Part applied to the vaping goods; and(c) contain the notification number and the indications or intended purposes; and(d) not be inconsistent with the information provided in the sponsor notice for the vaping goods; and(e) not be promoted at educational, scientific, trade or social events; and(f) not offer any personal payments, gifts, price discounts, incentives, or commissions, in exchange for recommending or supplying the vaping goods; and(g) not contain or consist of samples, or an offer of samples, of the vaping goods that are intended to be provided to a patient; and(h) not contain testimonials or endorsements about the vaping goods; and(i) not contain a prohibited representation or a restricted representation, as if one or more of those representations applied to the vaping goods\n- 4 advertising that is advice or information given directly to a patient by one or more of the following persons, in the course of the treatment of that patient for smoking cessation or the management of nicotine dependence:(a) a medical practitioner;(b) a nurse practitioner;(c) a pharmacist notified vaping goods the advertising must:(a) only contain representations or information relating to one or more of the following:(i) the availability and price of the vaping goods;(ii) information necessary for the safe and effective use of the vaping goods;(iii) information about the vaping goods, including the indications or intended purposes, ingredients, formulation, composition, design specification or presentation; and(b) comply with the requirements for therapeutic goods specified in Part 3 of the Therapeutic Goods Advertising Code, as if that Part applied to the vaping goods; and(c) contain the indications or intended purposes; and(d) not contain testimonials or endorsements about the vaping goods; and(e) not contain a prohibited representation or a restricted representation, as if one or more of those representations applied to the vaping goods\n- 5 advertising that is, or forms part of one or more of the following:(a) a Commonwealth health campaign;(b) a State health campaign vaping goods\n\n\n\n\n\nPart 2—Medicinal cannabis vaping goods\n\n \n\n- Authorised advertising\n- Column 1 Column 2 Column 3 Column 4\n- Item Advertising Vaping goods Conditions\n- 1 advertising that is:(a) on the label of the vaping goods; or(b) on the package in which the vaping goods are contained; or(c) on any material included with the package in which the vaping goods are contained medicinal cannabis vaping goods the advertising must:(a) comply with the requirements specified in TGO 93 as applicable to the vaping goods; and(b) comply with the requirements for therapeutic goods specified in Part 3 of the Therapeutic Goods Advertising Code, as if that Part applied to the vaping goods; and(c) not contain a prohibited representation or a restricted representation, as if those representations applied to the vaping goods\n- 2 advertising that is directed exclusively to one or more persons mentioned in subsections 42AA(1) or (2) of the Act medicinal cannabis vaping goods\n- 3 advertising that is advice or information given directly to a patient by a person mentioned in paragraphs 42AA(1)(a), (aa) or subsection 42AA(2) of the Act in the course of treatment of that patient medicinal cannabis vaping goods\n\n\n \n","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":false,"description":"The instrument exercises an authorisation power under section 42DZC to permit specified advertising types for defined vaping goods; it does not redefine the underlying categories or create new product types. It narrows permitted promotional channels and imposes conditions rather than expanding substantive regulatory scope beyond the Act and referenced standards. Commencement is linked to the Vaping Reforms Act."},"complexity_factors":["Extensive cross-references to multiple external instruments (TGO 110, TGO 93, MDSO, TG Regulations, MD Regulations, Therapeutic Goods Advertising Code).","Two distinct product categories with different applicable standards and conditions (notified vaping goods; medicinal cannabis vaping goods).","Multiple conditional authorisations differentiated by audience and medium (labels/packages, health professionals, wholesale/retail trade, clinician-to-patient advice, health campaigns).","Detailed, prescriptive conditions (e.g. inclusion of notification ID or indications, bans on testimonials, samples, gifts, event promotion, promotional payments).","Reliance on sponsor notices and Secretary/TGA determinations to establish eligibility or trigger supply cessation, creating administrative discretion.","Commencement contingent on the commencement of another Act (Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024).","Use of ‘as if’ formulations (apply Part 3 of the Advertising Code ‘as if’ it applied) that may raise interpretive questions in enforcement."],"plain_english_summary":"This instrument authorises specific kinds of advertising for two classes of vaping goods—‘notified vaping goods’ and ‘medicinal cannabis vaping goods’—under the Therapeutic Goods Act. It permits label/package statements, targeted communications to health professionals or trade, clinician advice to patients, and health-campaign messaging, but only if advertisers meet device/cannabis standards, Part 3 of the Therapeutic Goods Advertising Code, and avoid prohibited or restricted representations.\n\nSponsors and advertisers bear compliance costs and must follow conditions (for example, include notification numbers, omit testimonials, samples, gifts or promotional payments). The Secretary/TGA decides eligibility via sponsor notices and may require supply to stop."},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":false,"description":"This instrument appears to serve its original intended purpose as an advertising authorisation for specific categories of vaping goods under section 42DZC of the Therapeutic Goods Act 1989. It does not appear to have expanded beyond its original scope; rather, it implements the specific advertising permissions contemplated by the broader vaping reforms. The structure (two Parts for two distinct product categories) suggests focused, bounded application rather than scope creep."},"complexity_factors":["Heavy cross-referencing to at least 6 other legislative instruments (TGO 93, TGO 110, MDSO, TG Regulations, MD Regulations, Therapeutic Goods Advertising Code)","Multiple defined terms that themselves reference other regulations (e.g., 'medicinal cannabis product', 'therapeutic cannabis vaping good', 'intended purpose')","Nested conditional logic — advertising permissions depend on: (a) type of good, (b) audience, (c) specific conditions that must all be met simultaneously","Extensive 'as if' provisions — applying parts of the Advertising Code to goods that technically fall outside its scope, creating interpretive complexity","Duplicate condition structures across Parts 1 and 2 with subtle variations (e.g., Item 2 in Part 1 has 9 conditions; Item 2 in Part 2 has no conditions listed)","Reliance on external determinations (Secretary's power to stop supply based on public health concerns affects whether goods qualify as 'notified vaping goods')","Ambiguity in scope of 'medicinal cannabis vaping goods' — definition includes 'medicine that contains synthetic cannabis' which may not be intuitive"],"plain_english_summary":"This law creates narrow exceptions to Australia’s general ban on vaping advertising, allowing limited promotion only for two medical categories: notified nicotine vaping products and medicinal cannabis vaping goods. It affects sponsors, health professionals, supply‑chain businesses and patients by permitting tightly constrained promotion (labels, professional communications, supply‑chain notices and clinician advice) to ensure medical access while blocking consumer marketing that could encourage recreational use."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-vaping-goods-advertising-authorisation-2024","history":"/api/acts/therapeutic-goods-vaping-goods-advertising-authorisation-2024/history","analysis":"/api/acts/therapeutic-goods-vaping-goods-advertising-authorisation-2024/analysis","conflicts":"/api/acts/therapeutic-goods-vaping-goods-advertising-authorisation-2024/conflicts","importantCases":"/api/acts/therapeutic-goods-vaping-goods-advertising-authorisation-2024/important-cases","documents":"/api/acts/therapeutic-goods-vaping-goods-advertising-authorisation-2024/documents"}}