{"id":"F2008L04538","name":"Therapeutic Goods (Listing) Notice 2008 (No. 6)","slug":"therapeutic-goods-listing-notice-2008-no-6","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":120808,"registerId":"commonwealth-F2008L04538-current","compilationNumber":null,"startDate":"2026-04-03","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Listing) Notice 2008 (No. 6)","content":"![](image.001.png)\n\nTherapeutic Goods Act 1989\n\nTherapeutic Goods (Listing) Notice 2008 (No. 6)\n\nI, ROHAN HAMMETT, National Manager, Therapeutic Goods Administration, delegate of the Minister for Health and Ageing for the purposes of subsection 9A(5) of the Therapeutic Goods Act 1989 (‘the Act’) and acting under that provision, require the following therapeutic goods to be included in the part of the Australian Register of Therapeutic Goods (‘the ARTG’) for listed goods:\n\n-   preparations for the purposes of Item 3 of Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 (“the Regulations”) for oral use that contain dimethyl sulfone as a therapeutically active ingredient.\n\nAND\n\n-   preparations for the purposes of Item 3 of Part 1 of Schedule 4 of the Regulations for oral use that contain vegetable oil phytosterol esters, as a therapeutically active ingredient.\n\nsubject to the following conditions applicable to vegetable oil phytosterol esters:\n\nThe product label must include advisory statements to the effect of the following:\n\n\\- “There is no benefit from taking more than 3g/day of phytosterols from all sources”; and\n\n\\- “Not suitable for pregnant or lactating women”.\n\nThis Notice commences from the day after it is registered on the Federal Register of Legislative Instruments.\n\nPursuant to subsection 9A(6) of the Act this Notice ceases to have effect on the day that amendments to the Regulations come into effect to require inclusion of the therapeutic goods listed in this Notice in the part of the ARTG for listed goods.\n\nDated this 27th day of November 2008\n\nSigned by\n\nDr Rohan Hammett\n\nDelegate of the Minister for Health and Ageing","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":1718},"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The notice maintains its original narrow scope of permitting two specific therapeutic ingredients to be included in the listed medicines part of the ARTG with appropriate labelling conditions for phytosterol products."},"complexity_factors":["References to external legislative provisions (Schedule 4 of the Therapeutic Goods Regulations 1990)","Conditional requirements applying only to one of the two ingredient categories (phytosterol esters)","Delegated legislative authority framework requiring understanding of subsection 9A(5) of the Act"],"plain_english_summary":"This notice allows two specific supplement ingredients to be sold as **listed medicines** in Australia (a lower-regulation category for low-risk therapeutic goods).\n\n**What it covers:**\n- **Dimethyl sulfone** (also known as MSM) – for oral use\n- **Vegetable oil phytosterol esters** (plant sterols) – for oral use\n\n**What it means:**\nManufacturers can now list products containing these ingredients on the Australian Register of Therapeutic Goods (ARTG) without going through the full registration process required for higher-risk medicines.\n\n**Special rules for phytosterol products:**\nProducts containing vegetable oil phytosterol esters must carry two specific warnings on their labels:\n- That there's no health benefit from taking more than 3 grams per day of phytosterols\n- That the product is not suitable for pregnant or breastfeeding women\n\n**Why this matters:**\nThis creates a legal pathway for these supplements to be sold in Australia. Without this notice, products containing these ingredients couldn't be lawfully supplied. The notice remains in force until the regulations are formally updated to permanently include these ingredients."},"summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This notice is historical and no longer in force. Its requirements were superseded by permanent amendments to the Therapeutic Goods Regulations 1990."},"complexity_factors":["Cross-references to the Therapeutic Goods Regulations 1990 and the Therapeutic Goods Act 1989","Temporary operation with automatic cessation upon regulation amendment","Includes specific product label advisory statements"],"plain_english_summary":"The notice temporarily required oral products containing dimethyl sulfone (MSM) or vegetable oil phytosterol esters to be entered on the ARTG as listed goods, preventing their lawful supply in Australia unless listed and compliant. It also mandated specific warning and dosing statements for phytosterol ester products.\n\nIt has since been superseded by permanent amendments to the Therapeutic Goods Regulations, so the instrument is relevant only for historical or regulatory-evolution research."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-listing-notice-2008-no-6","history":"/api/acts/therapeutic-goods-listing-notice-2008-no-6/history","analysis":"/api/acts/therapeutic-goods-listing-notice-2008-no-6/analysis","conflicts":"/api/acts/therapeutic-goods-listing-notice-2008-no-6/conflicts","importantCases":"/api/acts/therapeutic-goods-listing-notice-2008-no-6/important-cases","documents":"/api/acts/therapeutic-goods-listing-notice-2008-no-6/documents"}}