{"id":"F2024L00845","name":"Therapeutic Goods (Determined Goods) Determination 2024","slug":"therapeutic-goods-determined-goods-determination-2024","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442482,"registerId":"F2024L00845-fast-fetch-1775957469760","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Determined Goods) Determination 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 (Determined Goods) Determination 2024\n\nI, Nicholas Henderson, as delegate of the Minister for Health and Aged Care, make the following determination.\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  Goods determined to be therapeutic goods\n\nSchedule 1—Therapeutic goods\n\nSchedule 2—Therapeutic 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 (Determined 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 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(Vaping Reforms) Act 2024 does not commence.\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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 7AAA of the Therapeutic Goods Act 1989.\n\n4  Definitions\n\nNote: A number of expressions used in this instrument are defined in section 3(1) of the Act, including the following:\n\n(a) therapeutic goods;\n\n(b) vaping goods.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\ntobacco product has the same meaning as in section 9 of the Public Health (Tobacco and Other Products) Act 2023.\n\n5  Goods determined to be therapeutic goods\n\n (1) The goods specified in Schedule 1 are determined to be therapeutic goods for the purposes of the Act.\n\n (2) For each item of the table in Schedule 2, the goods specified in column 2, when used, advertised, or presented for supply in a way specified in column 3, are determined to be therapeutic goods for the purposes of the Act.\n\n\n\n\nSchedule 1—Therapeutic goods\n\nNote: See subsection 5(1).\n\n- Goods determined to be therapeutic goods\n- Column 1 Column 2\n- Item Specified goods\n- 1 goods that contain nicotine and that are for human use (including but not limited to vaping goods) other than the following:(a) tobacco prepared and packed for smoking;(b) foods that contain naturally occurring nicotine, and do not contain added nicotine (whether natural or synthetic);(d) tobacco products that are permanently banned under Chapter 4 of the Public Health (Tobacco and Other Products) Act 2023Note 1: Vaping goods include heat-not-burn products.Note 2: Under section 126 of the Public Health (Tobacco and Other Products) Act 2023, chewing tobacco and snuffs intended for oral use are permanently banned.\n\n\n\n\n\nSchedule 2—Therapeutic goods when used, advertised or presented for supply in a particular way\n\nNote 1: See subsection 5(2).\n\nNote 2: Schedule 2 is intentionally blank, and reserved for future use.\n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The instrument aligns precisely with its stated purpose under the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024. It does not expand beyond the vaping reforms agenda; rather, it executes the specific technical step of 'determining' goods to be therapeutic goods as authorised by section 7AAA of the Therapeutic Goods Act 1989. The blank Schedule 2 suggests future-proofing but does not currently alter scope."},"complexity_factors":["Very short instrument (approximately 2 substantive sections plus schedules)","Only 2 defined terms in the instrument itself ('Act' and 'tobacco product')","Heavy reliance on external definitions (references to section 3(1) of the Therapeutic Goods Act 1989 and section 9 of the Public Health (Tobacco and Other Products) Act 2023)","Simple conditional structure (subsection 5(1) for Schedule 1, subsection 5(2) for Schedule 2)","Schedule 2 is intentionally blank (reserved for future use)","Single substantive item in Schedule 1 with nested exceptions (a), (b), and (d) — note the deliberate omission of (c) suggesting drafting continuity with other instruments"],"plain_english_summary":"This instrument reclassifies nicotine-containing products used for vaping and other non-smoking delivery systems as \"therapeutic goods\" under Australian law (with stated exceptions like smoked tobacco and certain foods). \n\nThat means these products are subject to the Therapeutic Goods Act—requiring approvals, prescriptions or permits—so recreational supply becomes effectively illegal while medical access and regulated supply remain possible."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":true,"description":"This instrument expands the regulatory scope by treating nicotine-containing goods for human use (including vaping and heat-not-burn products) as therapeutic goods, thereby bringing their manufacturers, importers and suppliers under the Therapeutic Goods Act (s5; Schedule 1). It preserves exclusions for certain tobacco and food products (Schedule 1, item 1), and its practical effect is conditional on commencement of the linked vaping-reforms Act (clause 2). Interpretation depends on cross-referenced definitions in the Therapeutic Goods Act and the Public Health (Tobacco and Other Products) Act."},"complexity_factors":["Broad regulatory change: designates nicotine-containing goods for human use (including vaping and heat-not-burn) as therapeutic goods — shifts many products into the Therapeutic Goods Act regime (Schedule 1, item 1; s5).","Cross‑references to other statutes and definitions increase interpretation tasks: relies on definitions in the Therapeutic Goods Act 1989 (s3(1)) and the Public Health (Tobacco and Other Products) Act 2023 (s9, s126).","Conditional commencement: the instrument only takes effect when Parts 1–3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence (clause 2), creating timing uncertainty for regulated parties.","Product classification questions: exclusions (tobacco prepared and packed for smoking; foods with naturally occurring nicotine; permanently banned tobacco products) require product-by-product legal assessment (Schedule 1, item 1).","Administrative discretion: made by a delegate under section 7AAA of the Act (clause 3), concentrating decision-making within the Departmental/Ministerial apparatus.","Future expansion point: Schedule 2 is intentionally blank and reserved, allowing the instrument’s scope to be extended later without creating a new instrument."],"plain_english_summary":"This instrument declares goods that contain nicotine and are for human use — including vaping and heat‑not‑burn products — to be \"therapeutic goods\" under the Therapeutic Goods Act 1989, while excluding tobacco prepared for smoking, foods with naturally occurring nicotine, and permanently banned tobacco products. Mechanically, this brings manufacturers, importers and suppliers of those nicotine products under the Act’s regulatory and compliance regime once the related vaping-reforms Act commences."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-determined-goods-determination-2024","history":"/api/acts/therapeutic-goods-determined-goods-determination-2024/history","analysis":"/api/acts/therapeutic-goods-determined-goods-determination-2024/analysis","conflicts":"/api/acts/therapeutic-goods-determined-goods-determination-2024/conflicts","importantCases":"/api/acts/therapeutic-goods-determined-goods-determination-2024/important-cases","documents":"/api/acts/therapeutic-goods-determined-goods-determination-2024/documents"}}