Therapeutic Goods (Declared Goods) Order 2019

The Order hinges on a small set of legal concepts and cross‑references that determine whether a product is captured by the Therapeutic Goods Act 1989. Those concepts are explicitly defined or invoked in the Order itself.

• Declaration mechanism. The instrument is a statutory declaration device: s 5 declares certain goods therapeutic, s 6 declares certain goods not therapeutic. The declaration is conditional , some entries apply unconditionally to a class, others apply only when use, advertising or presentation is in a specified way (s 5(2), s 6(2)). The effect is to create jurisdictional rules by composition, dosage form and representation.

• Composition + dosage form tests. Several Part 1 items treat composition together with dosage form as the trigger. For example, goods that "contain fibre" and "are manufactured in the dosage form of a tablet, capsule or pill" are declared therapeutic goods (Schedule 1, Part 1, item 2). Similarly, goods containing shark cartilage are captured when manufactured as a tablet, capsule, pill, or as a powder that is not a wholesale ingredient for food (Schedule 1, Part 1, item 4). The Order therefore uses pharmaceutical dosage form as a proxy for intended use and regulatory treatment.

• Representation and implied representation. Several items operate where a product is "represented (expressly or by implication)" to contain certain substances, or where it is represented for therapeutic uses or in a way likely to be taken as for therapeutic use (Schedule 1, Part 2, item 1A and others). The inclusion of implied representation broadens the trigger beyond explicit claims to encompass the product’s presentation and marketing.

• External reference lists. The Order imports external lists as part of its capture test. Item 1A relies on a substance being "included in a schedule to the current Poisons Standard" or "expressly identified on the Prohibited List" (Schedule 1, Part 2, item 1A(a)(i)-(ii)). The Definitions (s 4) clarify that "Prohibited List" means the WADA Prohibited List 2023 as in force or existing on 1 March 2023. The Poisons Standard is referenced as the "current Poisons Standard" (Definitions, s 4; note that "current Poisons Standard" is a defined expression in the Act, per the Definitions note). These cross‑references make the Order’s scope contingent on other regulatory or external decision‑making fora.

• "Relevant substance" carve‑out and definition. The Order creates a small bespoke category of "relevant substance" for its purposes that operates only when the substance is not already scheduled in the Poisons Standard or named on the WADA list. The defined relevant substances are dendrobium (Dendrobium nobile) and methylliberine (Definitions, s 4). Where those specific substances are added as ingredients to goods represented for sports performance, they trigger therapeutic classification (Schedule 1, Part 2, item 1A(a)(iii)).

• Temporal rule. Item 1A(b) contains a temporal cutoff: on or after 30 November 2023, supply in dosage form of tablet, capsule or pill (other than products containing glucose only) is required for capture. That is a forward‑looking supply condition that changes the dosage‑form element of capture from that date.

• Narrow negative carve‑outs. Schedule 2 lists specific consumer or industrial goods and defines narrow circumstances in which those goods are not therapeutic goods, e.g. soaps used for cleansing or spa water not promoted for therapeutic use (Schedule 2, Part 2). These entries limit the Act’s reach in specific, enumerated contexts.

Taken together, these concepts show the Order's two technical design features. First, it uses composition and pharmaceutical dosage form to treat certain consumer supplements or products as therapeutic goods. Second, it uses representational tests and references to external schedules/lists to import other regulatory criteria (Poisons Standard, WADA Prohibited List) into the therapeutic/non‑therapeutic decision. The result is an instrument that can capture products by label, marketing, or composition and that calibrates capture using external standards and a small bespoke substance list.

The instrument allocates regulatory consequences to three principal groups, identified from the text and the mechanics of the declarations.

• Manufacturers and importers. Entities that manufacture or import goods that match the compositional and dosage‑form criteria in Schedule 1, Part 1 (for example, goods that are or contain Cellasene; fibre in tablet/capsule/pill form; isolated HMB in tablet/capsule/powder form; shark cartilage in specified dosage forms) are directly affected because such goods are declared to be therapeutic goods (Schedule 1, Part 1, items 1-4). Manufacturers and importers must be alert to whether their formulation or physical presentation (tablet/capsule/pill per TGO 101) triggers the declaration.

• Marketers, brand owners and retailers. The Order captures goods based on representation or presentation as much as composition (Schedule 1, Part 2). A product that is the same composition but is marketed in a way that implies therapeutic use or performance enhancement (for example claims relating to gaining muscle, increasing stamina, altering hormone levels or weight loss , Schedule 1, Part 2, item 1A(c)-(j)) becomes a therapeutic good. The text makes express that the product can be represented “expressly or by implication” to contain specified substances or to be for sporting performance; advertising content, packaging, websites, and point‑of‑sale materials will therefore determine whether a product is declared a therapeutic good. Retailers and online marketplaces will be affected to the extent they host such representations or supply items presented in those ways.

• Product designers and formulators (nutraceutical/dietary supplement industry). The Order specifically captures ingredients commonly associated with sports supplements and nutraceutical markets: HMB, fibre in tablet form, shark cartilage, dendrobium, methylliberine, and folate forms used in foods for special medical purposes (Schedule 1, Part 1 & Part 2). Developers must check whether formulations that were previously sold as food or supplements are captured because of dosage form or promotional language.

Other affected parties include:

• Entities handling niche sources or branded ingredients. The Order defines “Trefriw Wells mineral water” and targets that product when used as a single‑use sachet iron supplement (Schedule 1, Part 2, item 2). Suppliers of that specific source of mineral water will be affected if they market it as an iron supplement in single sachets.

• Sellers of cosmetic products intended for oral consumption. Goods “labelled or promoted for cosmetic purposes” when presented for oral consumption are declared therapeutic goods (Schedule 1, Part 2, item 1). Cosmetic producers who previously treated an orally consumed product as categorically cosmetic will need to reassess.

• Producers and sellers of goods listed as non‑therapeutic under Schedule 2 in the specified uses remain outside the Act’s coverage only to the extent they keep within those narrow, specified non‑therapeutic presentations (e.g. soaps used only for cleansing, non‑prescription spectacles used solely for magnification or sun protection). Those actors benefit from certainty only if actual use and representation are limited to the specified non‑therapeutic contexts.

Who pays: the costs and compliance burdens fall principally on the manufacturers, importers, brand owners and retailers of products that are newly declared therapeutic goods or that risk being captured by representational tests. Those parties must decide whether to change formulation, dosage form, labelling, promotional language, or supply chain arrangements to avoid or accommodate therapeutic classification.

Who decides: the instrument itself is made under the Act (s 3 declares the instrument is made under s 7 of the Act). The determining features governing capture include: composition and dosage form (objectively discernible from the product), representations (marketing and packaging), and reference lists (Poisons Standard schedules; WADA Prohibited List). In effect, commercial actors decide through choices on formulation, packaging and marketing whether a product will meet the Order’s criteria for being a therapeutic good.

What behaviour changes: parties will likely reframe marketing claims, alter dosage forms (for example avoid tablet/capsule/pill format where that element creates capture), reformulate (remove specified ingredients or replace with glucose only in the case of item 1A(b) exception), or target a different market channel where the product is not presented as for therapeutic use. The Order’s combination of composition and representation triggers makes both labelling and physical form levers for compliance.

The Order itself creates declarations rather than prescriptive duties within its text. The key legal effects in this instrument are declaratory. The text sets boundaries that change whether goods are "therapeutic goods" for the purposes of the Therapeutic Goods Act 1989. Accordingly, the principal duty arising from the Order is the obligation of affected parties to recognise whether their goods fall within the declared categories and thereby are subject to the Act.

• Duty to determine classification. Producers, importers, marketers and suppliers have the immediate duty to determine whether a product meets an item in Schedule 1 (declared therapeutic) or falls within a Schedule 2 exclusion (declared not therapeutic for specified uses). The instrument specifies objective criteria: composition (e.g. contains fibre, contains HMB, contains shark cartilage), dosage form (tablet/capsule/pill/powder), representation (express or implied claims about sports performance, therapeutic uses) and supply conditions (single‑use sachet for Trefriw Wells water). Parties must analyse their goods against these criteria (see s 5 and Schedule 1 items; see s 6 and Schedule 2 items).

• Duty to ensure representations match legal status. Because several declarations hinge on representation or presentation, there is a practical duty to ensure advertising and labelling do not create implied representations that would trigger therapeutic classification (Schedule 1, Part 2, item 1A uses the phrase “represented (expressly or by implication)” and several items refer to goods “when used, advertised, or presented for supply” in certain ways). This changes the compliance problem from a purely compositional one into one that encompasses marketing and packaging decisions.

• Duty to track external lists and dates. Item 1A imports the current Poisons Standard and the WADA Prohibited List and includes a specific temporal rule for supply in tablet/capsule/pill on or after 30 November 2023 (Schedule 1, Part 2, item 1A(b)). Parties must therefore monitor those external lists and the instrument’s date thresholds. The instrument also limits the operation of the “relevant substance” definition to substances not already scheduled or listed (Definitions, s 4).

• Rights: the Order does not create positive entitlements within the text; it creates legal status changes (therapeutic or not). Rights relevant to regulated products will be those provided by the Act once a good is declared therapeutic. The instrument does not itself set out what those rights are. It does, however, grant certainty to businesses by listing precise compositional or representational triggers that determine therapeutic classification.

• Discretion and interpretive risk. The Order uses broad language in places (for example, “represented … by implication”, “in a way that is likely to be taken to be for therapeutic use”, and identifying substances by reference to schedules, the WADA Prohibited List and “substances with equivalent pharmacological action”). These formulations create interpretive questions. Affected parties must assess not only product content but how a reasonable consumer (or regulator) would interpret the presentation or implied claim. The instrument does not itself resolve those interpretive points; the classification may turn on enforcement or regulatory guidance under the Act.

Concrete textual anchors for duties and interpretive markers include s 5(1)-(2) (declarations of therapeutic goods), s 6(1)-(2) (declarations of non‑therapeutic goods), Schedule 1 items (the specific declared goods and representational triggers), Schedule 2 items (the non‑therapeutic exclusions) and the Definitions section (s 4), which ties tablet/capsule/pill definitions to TGO 101 and defines “Prohibited List” and “relevant substance”. These texts provide the sole statutory basis for classification decisions under the Order.

The Order itself does not specify penalties, fines or enforcement procedures. It is a declaratory instrument: ss 5 and 6 change the status of goods for the purposes of the Therapeutic Goods Act 1989. The Order is made under s 7 of the Act (s 3), so the enforcement and penalty consequences for goods that become therapeutic goods will flow from the Act’s regulatory framework rather than from the Order’s text.

What the Order does supply relevant to enforcement is the criteria by which a regulator or enforcer would identify goods subject to the Act. The regulator gains an objective checklist to determine whether a product is a therapeutic good: composition, dosage form, representation and supply mode (see Schedule 1). If a good meets one of those items, it is a therapeutic good under the Act as declared by s 5. Conversely, if a product falls within Schedule 2’s narrow exclusions (and the exclusion conditions are satisfied), it is declared not to be a therapeutic good (s 6).

Because the Order cross‑references external authoritative lists (the current Poisons Standard and the WADA Prohibited List), enforcement may also require consultation of those lists to determine capture. The instrument’s Definitions (s 4) state the Prohibited List is the WADA 2023 list as it existed on 1 March 2023; the Poisons Standard reference uses the phrase “current Poisons Standard”, which is a defined expression in the Act (the Order’s Definitions note this).

The instrument’s language introduces interpretive questions that affect enforcement risk: implied representation, “likely to be taken to be for therapeutic use”, and “substance with equivalent pharmacological action” are open to fact‑specific assessment. That means enforcement actions may depend on factual findings about marketing, presentation and consumer perception.

Practical enforcement implications from the text:

• The regulator may use composition and packaging/advertising to determine status. Because the Order explicitly triggers on representation and supply presentation, regulators can base enforcement on advertising materials, websites, packaging copy and point‑of‑sale claims, as well as analysis of the product’s constituents.

• The Order creates a potential for staged or contingent enforcement. Some triggers are temporal (e.g. the on/after 30 November 2023 condition in item 1A(b)), while others depend on lists external to the Order. Enforcement will need to verify the state of the Poisons Standard and the WADA list at relevant times.

• There is no penalty text in the Order. Any contravention of duties that flow from the Act will therefore be pursued under the Act’s enforcement regimes, sanctions and penalties, which are not set out in the instrument itself. The Order supplies the boundary rules; the Act supplies the sanctions.

Because the instrument does not itself create offences or enforceable sanctions, parties should consult the Therapeutic Goods Act 1989 for the specific legal consequences of supplying declared therapeutic goods. The Order’s role is to define which goods fall within the Act’s ambit.

The Order is explicitly designed to be read with and to import other regulatory references. Its interactions are primarily with the Therapeutic Goods Act 1989 (the enabling Act) and external standards referenced within it.

• Enabling statute. The Order is made under section 7 of the Therapeutic Goods Act 1989 (s 3). Its declarations change the classification of goods for the purposes of that Act, so the Order functions as an administrative instrument that alters the Act’s remit by naming classes of goods as therapeutic or not. The Order therefore operates as an accessory to the Act: the Act sets out the legal framework for therapeutic goods, and the Order defines what falls inside or outside that framework for the purposes of regulation.

• TGO 101. The Order imports definitions for capsule, tablet and pill from TGO 101 (Definitions, s 4). That connection means the technical meaning of dosage forms used as capture criteria in this Order depends on TGO 101’s definitions and standards. Where Schedule 1 items refer to "manufactured in the dosage form of a tablet, capsule or pill", those terms have the statutory meaning conferred by TGO 101.

• Poisons Standard. Item 1A(a)(i) captures "a substance included in a schedule to the current Poisons Standard". The Order therefore looks to the Poisons Standard to determine capture for products represented as being for sports performance. The Poisons Standard is dynamically referenced as the "current" edition, meaning changes to Poisons Standard schedules will alter which substances trigger capture under this instrument.

• WADA Prohibited List. The Order explicitly uses the World Anti‑Doping Agency's Prohibited List 2023 as the "Prohibited List" for the purposes of item 1A(a)(ii) and for the definition of substances expressly identified on that list (Definitions, s 4). The Order fixes the WADA list reference point as the 2023 list "as in force or existing on 1 March 2023". The Order therefore imports the content of that external list as a determinative instrument for capture, but it fixes the version date for the list (1 March 2023).

• Relation with food law and wholesale food ingredients. The Order draws distinctions between therapeutic classification and food regulation by exempting certain powders where they are "wholesale product[s] for use as an ingredient in food" from being therapeutic goods (Schedule 1, Part 1, item 4 - shark cartilage powders). Additionally, Schedule 1, Part 2, item 3 pertains to foods represented as "food for special medical purposes, or being for dietary management of a disease, disorder or medical condition". That bridging language shows the instrument sits at the interface of food regulation and therapeutic regulation and defines capture where foods are represented in medical or disease management contexts.

• Cosmetic regulation. Schedule 1, Part 2, item 1 declares goods that are "labelled or promoted for cosmetic purposes" to be therapeutic goods when used, advertised or presented for oral consumption. This creates an interaction with the regulatory borders of cosmetics, turning an orally consumed cosmetic presentation into a therapeutic good if presented for oral consumption.

• Product‑specific source definitions. The Order defines "Trefriw Wells mineral water" and treats that specific source of naturally occurring mineral water as a captured ingredient when represented as a single‑use sachet iron supplement (Schedule 1, Part 2, item 2). That creates a narrow interaction with any laws or standards that apply to imported or labelled mineral waters.

Overall, the Order is not self‑contained: it deliberately cross‑references and fixes the operation of external legal instruments, including TGO 101, the Poisons Standard, and a specified edition of the WADA Prohibited List. The Order’s reach therefore shifts as those external instruments and market presentations change, and compliance requires attention to multiple legal texts.

The instrument identifies itself as the Therapeutic Goods (Declared Goods) Order 2019 (s 1). The text provided for analysis includes references that indicate subsequent temporal or consequential linkages that affect how the instrument is read today.

Notable textual features relevant to amendment and updating:

• External list fixings and versioning. The Order defines "Prohibited List" as the World Anti‑Doping Agency Prohibited List 2023 "as in force or existing on 1 March 2023" (s 4). That definition effectively fixes the WADA list reference in the instrument to the 2023 list as of that date. The instrument therefore contains a built‑in version anchor with the effect that later updates to WADA’s list will not, under this instrument’s text, automatically alter the category of goods captured by references to the "Prohibited List", unless the Order itself is amended.

• Temporal supply rule. Item 1A(b) contains a temporal trigger: "on or after 30 November 2023, are supplied in the dosage form of a tablet, capsule or pill". That suggests an amendment or a staged implementation embedded within the instrument itself. The presence of that date in the operative text indicates the Order contemplates a change in effect on a specified future date from the instrument’s original 2019 numbering. The instrument text, as provided, includes that date in the operative schedule, so users must read the instrument as containing both retrospective and prospective operative components.

• Cross‑instrument references. The Order incorporates definitions from TGO 101, a separate legislative instrument. Because TGO 101 is independently made and may be amended, the Order’s practical application may change when TGO 101 is changed. The instrument’s Definitions section expressly ties the meanings of capsule, pill and tablet to TGO 101, so amendment of TGO 101 potentially affects the Order’s scope without amendment to the Order itself.

• Reserved provisions for future use. Schedule 2, Part 1 is "reserved for future use". That indicates the instrument was drafted to accommodate future amendments or insertions without replacing or remaking the entire Order.

• No explicit amendment schedule within the text beyond the dates and fixed WADA list referenced above. The Order itself records no history of prior amendments within the text provided; it simply contains references to other instruments and specific dates. Any formal amendment history (whether the Order has been amended since 2019 or the dates on which amendments took effect) is not recorded in the instrument text provided. The text as presented should therefore be read as the consolidated instrument that includes the 30 November 2023 rule and the 1 March 2023 WADA reference.

Because the instrument relies on external materials (Poisons Standard, TGO 101) whose content and schedules may change, and because it fixes certain external references to a particular date (WADA 2023 as at 1 March 2023) while including a prospective supply date (30 November 2023), parties must watch both (a) amendments to this instrument and (b) amendments to the external instruments and standards it imports. The instrument itself includes structural space for future amendments (Schedule 2, Part 1 reserved) and contingency in its cross‑references that will determine practical scope over time.

The Order’s text contains no reference to judicial decisions, appeals, or litigation. It does not record any case law, judicial interpretation, or adjudication history. The instrument is declaratory in form and establishes classification rules for goods; whether those rules have been the subject of litigation is not addressed in the text provided.

Consequences of that absence in the instrument text:

• No embedded precedent in the Order. The Order itself provides the legal criteria but contains no guidance on how courts or tribunals have interpreted the phrases used (for example “represented by implication”, “likely to be taken to be for therapeutic use”, or what constitutes a substance with “equivalent pharmacological action”). Those interpretive disputes, had they occurred, would appear in case law external to the instrument. The lack of case references in the instrument means that stakeholders must rely on administrative guidance, agency practice, or subsequent judicial decisions (none of which are recorded here) for clarification of ambiguous terms.

• Enforcement and adjudication will rest on the Act and on how regulators apply the Order. The instrument supplies the categories that determine whether a product is captured by the Act. Any legal disputes over classification, enforcement or penalties would be litigated under the Act or in administrative processes using the Order as the statutory source for classification. The Order itself does not report such litigation.

For practitioners preparing for potential disputes, the absence of litigation history in the instrument means two things: (1) classification questions may be novel and fact‑sensitive, especially around implied representations and pharmacological equivalence; (2) any litigation that tests the Order’s boundaries will have to start from the instrument text and the enabling Act, and the outcome will depend on how courts construe the instrument’s language and the factual record presented.

If a user requires information on judicial interpretation or enforcement experience, they will need to consult court and tribunal records, decisions under the Therapeutic Goods Act, and administrative determinations by the regulator, none of which are included in this instrument text.

The Order contains multiple traps for the unwary because it converts ordinary commercial choices into jurisdictional triggers. The following points draw directly from the instrument text and identify specific high‑risk features that can be decisive for legal classification.

• Representation can capture identical goods that are otherwise non‑therapeutic. Schedule 1, Part 2 repeatedly uses "represented (expressly or by implication)" and "when used, advertised, or presented for supply", which means identical physical products can be therapeutic goods or not depending on labelling and marketing. For example, an oral formulation containing a listed or equivalent substance sold for sports performance will be a therapeutic good under item 1A, whereas the same formulation positioned as a food supplement without therapeutic or performance claims might not be.

• Dosage form matters and is linked to TGO 101. Where composition alone might not capture a product, manufacture in the dosage form of a tablet, capsule or pill (terms defined by TGO 101) can. Items such as Schedule 1, Part 1, item 2 (fibre in tablet/capsule/pill) and Schedule 1, Part 1, item 3 (HMB in tablet/capsule/powder) show the importance of the physical dosage form. Converting a product from tablet to a liquid or gummy may change legal status; conversely, repackaging as a tablet can create regulatory capture.

• Broad substance categories, including "equivalent pharmacological action". Item 1A(a)(iv) captures "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". That language reaches chemical analogues and derivatives even if not named on lists. Manufacturers using novel compounds must consider this potentially wide net.

• Reliance on external lists both dynamic and fixed. Item 1A(a)(i) uses the "current Poisons Standard" (a moving target), while the instrument fixes the WADA list to the 2023 version as of 1 March 2023 (Definitions, s 4). That mixture of dynamic and fixed references means a substance might move into or out of capture through changes to the Poisons Standard but not via later WADA updates unless the Order is itself amended.

• "Relevant substance" exception is narrow and only applies if the substance is not scheduled or listed. The instrument creates a separate "relevant substance" class for dendrobium (Dendrobium nobile) and methylliberine, but only where those substances are not already on the Poisons Standard schedule or the Prohibited List (Definitions, s 4). That means those named substances are captured by the instrument unless they are already regulated elsewhere.

• Temporal and composition exceptions. Item 1A(b) introduces a future date requirement: on or after 30 November 2023 supply in tablet/capsule/pill form is required for capture (other than products containing glucose only). Practitioners must track the supply date. The “glucose only” exception is narrow and may be product‑specific.

• Narrow non‑therapeutic carve‑outs require strict adherence to conditions. Schedule 2 provides non‑therapeutic status only in narrow, enumerated situations. For example, spa water is not a therapeutic good only “when the goods are not used, advertised or presented for supply for therapeutic use” (Schedule 2, Part 2, item 7). If marketing shifts, the exclusion is lost.

• Specificity for named goods. The Order defines a single source, "Trefriw Wells mineral water", and captures it when used as a single‑use sachet iron supplement (Schedule 1, Part 2, item 2). Those dealing with branded or source‑specific ingredients must check whether an apparently minor branding or sourcing decision triggers capture.

• Food for special medical purposes and folate. Schedule 1, Part 2, item 3 captures products containing folate forms when represented as food for special medical purposes or dietary management of disease, and when used/advertised/presented for therapeutic use, including prevention or treatment of depression and folate deficiency. That item shows the instrument’s reach into the interface between food‑type products and medical nutrition.

• Wholesale ingredient exemption for powders. Shark cartilage powders are excluded from therapeutic classification only where the powder is a wholesale product for use as an ingredient in food (Schedule 1, Part 1, item 4(ii)). Downstream repackaging or retail sale may remove that exemption.

• No penalties or enforcement detail in the instrument. The Order sets classification rules but does not detail penalties. Parties should not assume the Order itself prescribes sanctions; instead, any enforcement will be under the Therapeutic Goods Act.

These "gotchas" are concrete, textual features of the Order. They show that label copy, marketing channels, physical form, ingredient sourcing and even the choice to sell a product in single‑use sachets can determine whether a good falls within the Act. Because many of the triggers are fact‑sensitive and presentation‑dependent, businesses should treat small changes in packaging, claims or dosage form as potentially determinative.

Compliance under this instrument requires a structured, product‑level assessment focused on composition, dosage form, representation and supply. The Order’s text yields a clear checklist approach.

1. Product triage against Schedule 1 and Schedule 2

   • Run each SKU against Schedule 1, Part 1 items: does it contain Cellasene; does it contain fibre and is it manufactured as a tablet/capsule/pill; does it contain or is it promoted to contain isolated HMB (or salts) and is it in tablet/capsule/pill/powder; does it contain shark cartilage in a captured form? (Schedule 1 Part 1, items 1-4).
   • If the physical form or ingredient matches, class the product as a declared therapeutic good unless a defined exception in the Schedule applies (e.g. shark cartilage powder that is a wholesale ingredient in food).
   • Where composition alone does not capture the product, check Schedule 1, Part 2: is the product represented for sport/exercise performance and does it contain a substance in a Poisons Standard schedule, a substance expressly on the WADA Prohibited List (WADA 2023 as at 1 March 2023), a “relevant substance” as defined (dendrobium, methylliberine) provided not scheduled/listed, or a pharmacological equivalent (Schedule 1, Part 2, item 1A(a))? If so, and if supplied in tablet/capsule/pill form on or after 30 Nov 2023 (item 1A(b), subject to the glucose exception), classify as therapeutic.
   • Check for presentation‑dependent captures: cosmetics for oral consumption (Schedule 1, Part 2, item 1), Trefriw Wells mineral water used as single sachet iron supplement (item 2), folate‑containing FSMP or dietary management foods presented for therapeutic use (item 3).
   • Cross‑check Schedule 2 exclusions: where products fall clearly within an exclusion (e.g. deodorant for dermal application, soap used for cleansing), document and ensure marketing and presentation stay strictly within the exclusion conditions to retain the non‑therapeutic status.

2. Audit labelling, packaging and marketing

   • Because the instrument turns on “representation (expressly or by implication)” and “used, advertised or presented for supply”, audit all advertising channels (labels, package inserts, point‑of‑sale materials, websites, social media, influencer posts) for claims that could be read as therapeutic or as improving sports/exercise performance (Schedule 1, Part 2, item 1A(c)-(j) lists likely therapeutic uses).
   • Remove or reframe any verbal or visual content that implies therapeutic benefit, sports performance enhancement, hormone modification, weight loss, muscle gain, stamina improvement, or workout preparation/recovery, unless the product is intended to be regulated as a therapeutic good and the manufacturer is prepared to meet Act requirements.

3. Assess dosage form strategically

   • If a product is close to capture because of dosage form (tablet/capsule/pill), consider alternative dosage forms (liquid, powder for mixing, gummy, sachet) where those forms do not trigger Schedule 1 items, subject to TGO 101 definitions. Remember that item 1A includes a temporal element for supply on or after 30 November 2023, so timing of conversion matters.

4. Monitor external lists and dates

   • Track the current Poisons Standard (used dynamically by the instrument) to see whether ingredients used are scheduled, which would trigger item 1A(a)(i).
   • Note that the WADA Prohibited List reference is fixed to the 2023 list as at 1 March 2023 in this instrument. Where WADA’s list changes after that date, the instrument’s capture by WADA list will not automatically change without amending the instrument.
   • Observe the 30 November 2023 supply date in item 1A(b) for tablet/capsule/pill capture and plan product launches or packaging changes accordingly.

5. Document decision rationales and maintain evidence

   • Keep contemporaneous records showing why a product is considered therapeutic or not, including ingredient lists, labelling text, advertising communications, and distribution formats. For products relying on Schedule 2 exclusions, document that the product is used/presented only in the non‑therapeutic manner and monitor for any changes that could void the exclusion.

6. Consider reformulation where necessary

   • If ingredients such as dendrobium, methylliberine, HMB, shark cartilage or other captured substances create regulatory exposure, consider reformulating to remove those ingredients or substitute with ingredients that do not meet the captured categories.
   • Where HMB or similar actives are essential to the product’s value proposition, consider engaging with the regulatory pathway under the Therapeutic Goods Act rather than trying to avoid classification.

7. Engage with legal or regulatory advisers before changing presentation

   • Because many triggers involve implied representation and "equivalent pharmacological action", seek specialist regulatory advice where there is ambiguity, especially for new chemistries, novel analogues or borderline marketing claims.

8. For branded/source‑specific products, check narrow definitions

   • If using named water sources or branded ingredients (for example, Trefriw Wells mineral water), verify whether the instrument specifically defines or captures the source and whether presentation (single‑use sachet iron supplement) would trigger classification.

9. Where the business intends to market as a therapeutic good

   • If the company elects to accept therapeutic classification, it should plan to comply with the Therapeutic Goods Act 1989 requirements applicable to therapeutic goods (registration, listing, manufacturing standards, advertising limitations), keeping in mind this Order only determines classification and not the procedural requirements under the Act.

10. Operational controls for retailers and platforms

    • Retailers and online platforms should implement content‑moderation rules to prevent third parties from making therapeutic or performance claims that would create declared therapeutic goods within their inventory, unless the retailer is prepared for the regulatory consequences.

Follow these steps for each product SKU and at every point of marketing or formulation change. The Order’s combination of objective composition/dosage triggers with subjective representational triggers means compliance is both a technical product review task and an advertising/content control task. Documentation and clear decision‑making trail are essential in case the product’s status is questioned by an enforcement authority.