{"id":"F2019L01352","name":"Therapeutic Goods (Declared Goods) Order 2019","slug":"therapeutic-goods-declared-goods-order-2019","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":100193,"registerId":"commonwealth-F2019L01352-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n This instrument is the Therapeutic Goods (Declared Goods) Order 2019.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under section 7 of the Therapeutic Goods Act 1989.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 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) current Poisons Standard;\n\n(c) manufacture;\n\n(d) presentation;\n\n(e) supply;\n\n(f) therapeutic goods; and\n\n(g) therapeutic use.\n\n In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> capsule has the same meaning as in TGO 101.\n\n> pill has the same meaning as in TGO 101.\n\n> Prohibited List means the World Anti-Doping Code International Standard Prohibited List 2023 published by the World Anti-Doping Agency, as in force or existing on 1 March 2023.\n\n> Note: The Prohibited List is published on the World Anti-Doping Agency (WADA) website at https://www.wada‑ama.org/en.\n\n> relevant substance means any of the following substances, where the substance is not included in a schedule to the current Poisons Standard or expressly identified on the Prohibited List:\n\n (a) dendrobium (Dendrobium nobile);\n (b) methylliberine.\n\n> tablet has the same meaning as in TGO 101.\n\n> TGO 101 means the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019.\n\n> Note: TGO 101 is a legislative instrument published on the Federal Register of Legislation at https://www.legislation.gov.au.\n\n> Trefriw Wells mineral water means naturally-occurring mineral water sourced from Trefriw Wells Spa in the United Kingdom.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Declared goodstherapeutic goods","content":"#### 5 Declared goodstherapeutic goods\n\n (1) The goods or classes of goods specified in Part 1 of Schedule 1 to this instrument are declared to be therapeutic goods.\n (2) The goods or classes of goods specified in column 2 of an item in the table in Part 2 of Schedule 1 to this instrument, when used, advertised, or presented for supply, in a way specified in column 3 of that item, are declared to be therapeutic goods.","sortOrder":3},{"sectionNumber":"6","sectionType":"section","heading":"Declared goodsnot therapeutic goods","content":"#### 6 Declared goodsnot therapeutic goods\n\n (1) The goods or classes of goods specified in Part 1 of Schedule 2 to this instrument are declared not to be therapeutic goods.\n (2) The goods or classes of goods specified in column 2 of an item in the table in Part 2 of Schedule 2 to this instrument, when used, advertised, or presented for supply, in a way specified in column 3 of that item, are declared not to be therapeutic goods.\n\nSchedule 1—Therapeutic goods\n\nNote: See section 5.","sortOrder":4},{"sectionNumber":"Part 1","sectionType":"part","heading":"Therapeutic goods","content":"## Part 1—Therapeutic goods\n\n```html\n

Goods that are therapeutic goods

Column 1

Column 2

Item

Goods or classes of goods

1

goods that are or contain Cellasene

2

goods that:

(a) contain fibre; and

(b) are manufactured in the dosage form of a tablet, capsule or pill

3

goods that:

(a) contain, or are promoted to contain, isolated b-hydroxy-b-methylbutyrate (HMB) or its salts; and

(b) are manufactured in the dosage form of a tablet, capsule, pill or powder

4

goods that:

(a) contain shark cartilage; and

(b) are manufactured in the dosage form of:

(i) a tablet, capsule or pill; or

(ii) a powder, where that powder is not a wholesale product for use as an ingredient in food

\n```","sortOrder":5},{"sectionNumber":"Part 2","sectionType":"part","heading":"Therapeutic goods when used, advertised, or presented for supply in a particular way","content":"## Part 2—Therapeutic goods when used, advertised, or presented for supply in a particular way\n\n```html\n

Goods that are therapeutic goods when used, advertised, or presented for supply in a particular way

Column 1

Column 2

Column 3

Item

Goods or classes of goods

Use, advertising or presentation

1A

goods for oral administration that are represented (expressly or by implication) as being for the improvement or maintenance of physical or mental performance in sport, exercise or recreational activity, and that:

(a) contain, or are represented (expressly or by implication) to contain, one or more of the following substances (however described or named):

(i) a substance included in a schedule to the current Poisons Standard; or

(ii) a substance expressly identified on the Prohibited List that is added as an ingredient to the goods; or

(iii) a relevant substance that is added as an ingredient to the goods; or

(iv) a substance with equivalent pharmacological action to a substance mentioned in subparagraph (i), (ii) or (iii), including those that may be characterised as an active principle, precursor, derivative, salt, ester, ether or stereoisomer; or

(b) on or after 30 November 2023, are supplied in the dosage form of a tablet, capsule or pill, other than those goods containing glucose only

when the goods are used, advertised, or presented for supply:

(a) for therapeutic use; or

(b) in a way that is likely to be taken to be for therapeutic use;

including, but not limited to, one or more of the following therapeutic uses:

(c) gaining muscle;

(d) increasing mental focus;

(e) increasing metabolism;

(f) increasing stamina;

(g) increasing testosterone levels, reducing oestrogen levels or otherwise modifying hormone levels;

(h) losing weight or fat;

(i) preparing for workout;

(j) recovering from workout

1

goods that are labelled or promoted for cosmetic purposes

when used, advertised or presented for supply for oral consumption

2

goods that contain Trefriw Wells mineral water

when used, advertised or presented for supply for therapeutic use:

(a) as an iron supplement; and

(b) in a single use sachet

3

goods that:

(a) contain one or more of the following folate substances:

(i) folic acid; or

(ii) folinic acid; or

(iii) levomefolic acid; or

(iv) any other form of folate that may be characterised as an active principle, precursor, derivative, salt, ester, ether or stereoisomer; and

(b) are represented as being food for special medical purposes, or being for dietary management of a disease, disorder or medical condition;

whether or not the recommended single dose of the goods contains sufficient macronutrients to feed, either exclusively or partially, the person for whom the dose is intended

when used, advertised, or presented for supply:

(a) for therapeutic use; or

(b) in a way that is likely to be taken to be for therapeutic use;

including, but not limited to, one or more of the following therapeutic uses:

(c) preventing, curing or alleviating depression;

(d) curing or alleviating an inborn error of folate metabolism;

(e) preventing, curing or alleviating folate deficiency;

and that therapeutic use can be taken to relate to a substance mentioned in paragraph (a) in column 2 of this item

\n```\n\n \n\nSchedule 2—Not therapeutic goods\n\nNote: See section 6.","sortOrder":6}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":true,"description":"The legislation has grown significantly beyond simple classification. The original 2019 instrument has been amended to include complex sports supplement regulations (Item 1A) that incorporate external anti-doping lists, specific activation dates, and detailed pharmacological catch-all provisions. The scope now encompasses sophisticated regulatory engineering for the sports nutrition industry, anti-doping policy alignment, and specific product exemptions (like the UK mineral water), moving well beyond a straightforward declaratory instrument."},"complexity_factors":["Multiple cross-references to external documents: the Poisons Standard, WADA Prohibited List 2023, and TGO 101 (a separate legislative instrument)","Conditional logic based on how products are \"used, advertised, or presented for supply\" — creating context-dependent classification","Nested definitions: \"relevant substance\" excludes substances already in the Poisons Standard or Prohibited List, creating a double-negative exclusion","Date-triggered provisions: Item 1A in Schedule 1 has a specific activation date (30 November 2023) for certain dosage forms","Pharmacological equivalence clauses that catch \"active principles, precursors, derivatives, salts, esters, ethers or stereoisomers\" — requiring scientific expertise to interpret","Specific geographic and source-based definitions (Trefriw Wells mineral water from a specific UK spa)","Dual-structure format with both \"declared to be\" and \"declared not to be\" therapeutic goods, requiring comparison across Schedules 1 and 2"],"plain_english_summary":"This law redefines what counts as “therapeutic goods” in Australia, bringing many supplements, certain cosmetic/consumer products and some mineral waters under the Therapeutic Goods Act — and requiring approval, quality controls and permitted claims. It also carves out specific non-therapeutic uses to keep ordinary foods and personal-care items exempt.\n\nManufacturers, sellers and consumers of supplements, sports performance products and related items are most affected: misclassification risks illegal unapproved medicines or unnecessary regulatory burdens."},"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":false,"description":"The instrument operates within the grant of power in section 7 of the Therapeutic Goods Act to declare goods therapeutic or not. It clarifies and narrows the Act's application to particular consumer products (notably certain sports/performance products, forms of fibre, HMB, shark cartilage, folate preparations, and a specific mineral water use). These are targeted reclassifications rather than an expansion beyond the Act's structural purpose. In other words, the Order changes which products fall under the therapeutic regime but does so by exercising the statutory power in a focused way rather than growing the statutory scheme into entirely new subject matter."},"complexity_factors":["Cross‑references to external instruments and lists (Poisons Standard; TGO 101; WADA Prohibited List) including a date‑fixed WADA list (definition in section 4)","Conditional logic linking ingredient content, dosage form, and advertising/presentation (Schedule 1 Part 2, item 1A)","Mixture of absolute (Part 1) and conditional (Part 2) declarations across two Schedules (requires context‑sensitive application)","Specific dosage‑form exceptions and carve outs (e.g. tablet/capsule/pill vs powder; powder wholesale exception in Schedule 1 item 4(ii))","Date triggers (goods supplied on or after 30 November 2023; Prohibited List as at 1 March 2023)","Relatively small defined list of novel \"relevant substances\" combined with a broader 'equivalent pharmacological action' clause (creates interpretive scope)","Reliance on advertising/presentation tests (‘represented (expressly or by implication)’, 'likely to be taken to be for therapeutic use') which are fact‑sensitive and increase enforcement complexity"],"plain_english_summary":"**What this instrument does (mechanically)\n\n- Declares particular products to be \"therapeutic goods\" under the Therapeutic Goods Act 1989, and declares other products not to be therapeutic goods, by listing them in schedules attached to the instrument (see section 5 and Schedule 1; section 6 and Schedule 2).\n\n- Uses two methods:\n - Absolute declarations: certain goods or classes are therapeutic goods regardless of how they are presented (Schedule 1, Part 1 — e.g. goods that are or contain Cellasene; fibre in tablet/capsule/pill form; HMB in certain dosage forms; shark cartilage in certain dosage forms).\n - Conditional declarations: some goods become therapeutic goods only when used, advertised or presented in particular ways (Schedule 1, Part 2 — e.g. oral products promoted for improving sporting performance that contain certain substances; folate products presented as \"food for special medical purposes\").\n\n- Equally, Schedule 2 lists goods that are not therapeutic goods when they are used or presented in particular ways (for example deodorant preparations for dermal use, soaps for cleansing skin, spa/mineral water when not promoted for therapeutic use).\n\n**Who is affected\n\n- Manufacturers, importers, advertisers, sponsors and suppliers of the listed products: if a product is declared a therapeutic good it falls within the TGA regime and the supplier must comply with the Act's requirements (registration/entry on the Australian Register of Therapeutic Goods (ARTG), labelling, manufacturing standards, advertising restrictions, etc.). The practical burden falls mostly on businesses that make, market, import or supply the specified products.\n\n- Consumers: the regulatory status of particular consumer products (especially sports supplements, tablets/capsules containing certain ingredients, and certain folate or iron preparations) will change the way those products are sold and labelled.\n\n- Advertisers and retailers: whether an item is treated as a therapeutic good depends not only on ingredients but on how it is represented or presented for supply (advertising claims, suggested uses, packaging, dosage form).\n\n**Key definitions and cross‑references that matter (where to look in the instrument)\n\n- Definitions are in section 4: the Order relies on definitions already in the Act and borrows defined forms from TGO 101 (tablets, capsules, pills). It also defines a frozen WADA Prohibited List reference (\"Prohibited List\" as the WADA list in force on 1 March 2023) and a short \"relevant substance\" list (dendrobium nobile; methylliberine).\n\n- The declaration that certain sport/performance products are therapeutic goods is conditional on ingredient/content tests (substances scheduled in the Poisons Standard, substances expressly on the Prohibited List as at 1 Mar 2023, the local \"relevant substances\", or substances with equivalent pharmacological action) and on presentation (e.g. supplied as tablet/capsule/pill after 30 Nov 2023) (Schedule 1, Part 2, item 1A).\n\n**Why this matters (claimed purpose and practical effects)\n\n- The instrument's stated effect is to bring certain consumer products within the therapeutic goods regulatory framework so they are regulated under the Therapeutic Goods Act (see section 5 and Schedule 1).\n\n- Practical effects and trade‑offs to note:\n - Compliance costs: manufacturers/suppliers of declared products will generally face additional compliance obligations (ARTG listing or other TGA pathways, labelling, quality/manufacturing standards, advertising restrictions). These are direct costs to producers and likely raise barriers to market entry for smaller suppliers (see the declaration mechanism in Schedule 1 and the reliance on presentation/advertising tests in Schedule 1 Part 2).\n - Behavioural substitution by industry: companies can change product form or presentation to avoid the declaration (for example, offering a powder as a wholesale ingredient rather than a packaged powder for consumer sale, or avoiding tablet/capsule forms where the declaration is specific to those dosage forms) — the instrument itself creates these incentives through its dosage‑form and presentation triggers (see Schedule 1, Part 1 and Part 2, item 1A; Schedule 1 item 4(ii) excludes powder that is a wholesale ingredient from the shark‑cartilage item).\n - Reliance on external lists and dates: the Order cross‑references the current Poisons Standard, TGO 101, and the WADA Prohibited List as at 1 March 2023. The WADA list reference is fixed to that date in the instrument, which freezes which WADA entries are relevant for the Order (section 4 definitions). That reduces automatic automaticity from later WADA changes but creates a need to monitor whether the instrument will be updated if WADA adds/removes substances.\n - Enforcement and discretionary interpretation: whether something counts as \"represented (expressly or by implication)\" for a therapeutic purpose depends on how advertising/presentation is read; this gives regulators scope to test marketing claims against the declaration (Schedule 1, Part 2 tests). That creates compliance uncertainty where claims are borderline.\n - Concentrated vs diffuse effects: the costs are concentrated on particular manufacturers/suppliers (especially sports supplement makers using tablets/capsules and sellers of Cellasene, HMB or shark cartilage in certain forms) while benefits (consumer protection, doping risk reduction) are diffused. The instrument mechanically transfers regulatory costs onto suppliers of the listed goods.\n\n**Some concrete examples from the instrument (mechanical triggers)\n\n- Any product that \"is or contains Cellasene\" is declared a therapeutic good (Schedule 1, Part 1, item 1).\n\n- A product that contains fibre and is made as a tablet, capsule or pill is a therapeutic good (Schedule 1, Part 1, item 2).\n\n- Oral products represented as for improving sporting or exercise performance and that contain: (a) a substance scheduled in the Poisons Standard, or (b) a substance expressly on the WADA Prohibited List (as at 1 Mar 2023), or (c) a \"relevant substance\" (dendrobium nobile or methylliberine), or (d) any substance with equivalent pharmacological action — and that are supplied in tablet/capsule/pill form on or after 30 Nov 2023 (except glucose-only goods) — are therapeutic goods when advertised/presented/used as for therapeutic use (Schedule 1, Part 2, item 1A).\n\n- Goods that are spa or natural mineral water are not therapeutic goods so long as they are not represented for therapeutic use (Schedule 2, Part 2, item 7). However, a specifically defined \"Trefriw Wells mineral water\" when used as a single‑use sachet iron supplement is declared a therapeutic good (definition in section 4; Schedule 1, Part 2, item 2).\n\n**Implementation risks and administrative frictions\n\n- Ambiguity in marketing claims: the test relies on how goods are \"used, advertised or presented for supply\" and on phrases like \"likely to be taken to be for therapeutic use\" (Schedule 1, Part 2). That invites case‑by‑case assessment and potential compliance disputes.\n\n- Timing and transition: the 30 November 2023 date for dosage‑form supply in item 1A sets a hard compliance trigger for certain sports performance tablets/capsules; suppliers must adjust before or after that date depending on the clause.\n\n- External list management: because the instrument links to the Poisons Standard and freezes the WADA list to a particular date, administrators and businesses must manage two different update regimes — one dynamic (Poisons Standard, which is updated regularly) and one frozen (WADA list as at 1 Mar 2023) — which complicates compliance monitoring.\n\n**Where to read the rules in the instrument**\n- The power to make the instrument: section 3 (authority under section 7 of the Act).\n- Definitions and key cross‑references: section 4.\n- Declarations making goods therapeutic: section 5 and Schedule 1 (Parts 1 & 2).\n- Declarations that goods are not therapeutic: section 6 and Schedule 2 (Part 2).\n\nThis summary focuses on how the Order changes regulatory classification and the direct legal and economic consequences of that reclassification. It does not evaluate the policy merits of the changes; it reports the mechanisms, who bears costs, what choices suppliers will face, and the principal implementation frictions (with instrument references as noted)."},"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"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-declared-goods-order-2019","history":"/api/acts/therapeutic-goods-declared-goods-order-2019/history","analysis":"/api/acts/therapeutic-goods-declared-goods-order-2019/analysis","conflicts":"/api/acts/therapeutic-goods-declared-goods-order-2019/conflicts","importantCases":"/api/acts/therapeutic-goods-declared-goods-order-2019/important-cases","documents":"/api/acts/therapeutic-goods-declared-goods-order-2019/documents"}}