{"id":"F2024L00841","name":"Therapeutic Goods (Vaping Goods) Determination 2024","slug":"therapeutic-goods-vaping-goods-determination-2024","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442479,"registerId":"F2024L00841-fast-fetch-1775957467487","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Vaping Goods) Determination 2024","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\nmeta-description: legislation\ntitle: \"DRAFT: Therapeutic Goods (Declared Goods) Order 2019\"\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) Determination 2024\n\nI, Nicholas Henderson, as delegate of the Minister for Health and Aged Care, make the following determination.\n\nDated 29 June 2024\n\nNicholas Henderson\n\nActing Deputy Secretary  Health Products Regulation Group\n\nDepartment of Health and Aged Care\n\n \n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Specified goodsvaping goods\n\n6  Specified goodsnot vaping goods\n\nSchedule 1—Vaping goods\n\nPart 1—Vaping goods\n\nPart 2—Vaping goods when used, advertised, or presented for supply in a particular way\n\nSchedule 2—Not vaping goods\n\nPart 1—Not vaping goods\n\nPart 2—Not vaping goods when used, advertised, or presented for supply in a particular way\n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Vaping Goods) Determination 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 commences.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 subsection 41P(3) 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) manufacture;\n\n(c) presentation;\n\n(d) Register;\n\n(e) supply;\n\n(f) therapeutic goods.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nnicotine has the same meaning as in TGO 110.\n\nTGO 110 means the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021.\n\nNote: TGO 110 is a legislative instrument that may be access on the Federal Register of Legislation at www.legislation.gov.au.\n\n5  Specified goodsvaping goods\n\n (1) The goods or classes of goods specified in Part 1 of Schedule 1 are determined to be vaping goods.\n\n (2) For each item of the table in Part 2 of Schedule 1, the goods or classes of goods specified in column 2, when used, advertised, or presented for use or supply in a way specified in column 3, are determined to be vaping goods.\n\n6  Specified goodsnot vaping goods\n\n (1) The goods or classes of goods specified in Part 1 of Schedule 2 are determined not to be vaping goods.\n\n (2) For each item of the table in Part 2 of Schedule 2, the goods or classes of goods specified in column 2, when used, advertised, or presented for use or supply in a way specified in column 3, are determined not to be vaping goods.\n\n\n\n\nSchedule 1—Vaping goods\n\nNote: See section 5.\n\nPart 1—Vaping goods\n\nNote: This Part is intentionally blank, and is reserved for future use.\n\n\n\n\nPart 2—Vaping goods when used, advertised, or presented for supply in a particular way\n\nNote: This Part is intentionally blank, and is reserved for future use.\n\n\n\n\nSchedule 2—Not vaping goods\n\nNote: See section 6.\n\nPart 1—Not vaping goods\n\n- Goods that are not vaping goods\n- Column 1 Column 2\n- Item Goods or classes of goods\n- 1 therapeutic goods that contain nicotine in liquid form that are included in the Register for:(b) oromucosal or transdermal administration; and(c) use as an aid in withdrawal either from tobacco smoking or nicotine vaping\n\n\n\n\n\nPart 2—Not vaping goods when used, advertised, or presented for supply in a particular way\n\nNote: This Part is intentionally blank, and is reserved for future use.\n","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"The instrument makes explicit determinations about what is and is not a vaping good (see section 5 and section 6). It excludes registered nicotine therapeutic products authorised for oromucosal or transdermal administration as withdrawal aids (Schedule 2 Part 1 item 1). The instrument is made under subsection 41P(3) of the Therapeutic Goods Act 1989 (section 3) and relies on the TGO 110 definition of nicotine (section 4). The text does not state it amends or replaces a prior determination; on its face it establishes classification rules but provides no basis within the instrument to conclude a change from any earlier intent."},"complexity_factors":["Short instrument but relies on external definitions and instruments (Act s3(1), TGO 110) which require cross-referencing","Commencement is conditional on another amending Act, creating timing and implementation uncertainty (Commencement provision)","Key determinations depend on entries in the Register (Schedule 2 Part 1 item 1), requiring factual verification of product registrations","Delegated legislative power under subsection 41P(3) concentrates decision-making authority in the delegate (Authority provision)","Several Parts/schedules are intentionally blank and reserved for future use, adding potential future scope changes"],"plain_english_summary":"This instrument declares which products are treated as “vaping goods” under the Therapeutic Goods Act and separately lists goods that are not vaping goods. It specifically excludes nicotine-containing therapeutic products that are registered for oromucosal or transdermal use as aids for withdrawal from smoking or vaping. That classification determines whether manufacturers, suppliers and advertisers of those products fall within therapeutic‑goods regulation."},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"This appears to be the original intended scope — a skeletal framework instrument designed to be populated later. The blank schedules and conditional commencement (dependent on the companion Act) indicate this was always intended as a placeholder mechanism rather than a document that has grown beyond its original purpose."},"complexity_factors":["Extremely short — only 6 operative sections plus schedules","Minimal defined terms (only 3: 'Act', 'nicotine', 'TGO 110')","Simple conditional structure (if in Schedule 1 = vaping good; if in Schedule 2 = not vaping good)","Heavy reliance on external documents — TGO 110 and the companion Act are essential to understanding scope","Schedules 1 and Part 2 of both schedules are intentionally blank, creating regulatory uncertainty until populated","Only one substantive exemption currently specified (nicotine replacement therapies in Schedule 2, Part 1)","No nested exceptions or complex logical operators"],"plain_english_summary":"This instrument defines which products count as \"vaping goods\" under Australia’s therapeutic goods rules, setting a two-way classification (what is and is not a vaping good) that determines whether a product needs TGA approval and pharmacy-only supply. It expressly excludes already‑listed nicotine replacement therapies to avoid double regulation.\n\nIt matters to vape manufacturers, importers, pharmacies and consumers because it is the gatekeeper framework for the 2024 vaping reforms; the schedules are currently blank and will be populated later."},"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"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-vaping-goods-determination-2024","history":"/api/acts/therapeutic-goods-vaping-goods-determination-2024/history","analysis":"/api/acts/therapeutic-goods-vaping-goods-determination-2024/analysis","conflicts":"/api/acts/therapeutic-goods-vaping-goods-determination-2024/conflicts","importantCases":"/api/acts/therapeutic-goods-vaping-goods-determination-2024/important-cases","documents":"/api/acts/therapeutic-goods-vaping-goods-determination-2024/documents"}}