Australia New Zealand Food Standards Code – Standard 2.9.5 – Food for special medical purposes

Key statutory concepts in the Standard are defined by cross-reference and by express definitions in the Standard text. These concepts determine scope, compositional obligations and labelling duties.

• Food for special medical purposes (FSMP). The definition is given by cross-reference to section 1.1.2,5 (reproduced in Note 1). An FSMP is a food "specially formulated for the dietary management" of individuals with medically determined nutrient requirements or impaired capacity to use ordinary food, whose dietary management "cannot be completely achieved without the use of the food", is "intended to be used under medical supervision" and is represented as an FSMP or "for the dietary management of a disease, disorder or medical condition" (Note 1(1)). Two express exclusions apply: FSMP does not include infant formula products, nor foods formulated for overweight/obesity management unless they are a "very low energy food" (Note 1(2)).
• Responsible institution. Defined by Note 2 as hospitals, hospices, aged care, disability facilities, prisons, boarding schools or similar institutions "responsible for the welfare of its patients or residents and provides food to them" (Note 2). This feeds into sale-channel exemptions and inner-package rules (2.9.5,5 and 2.9.5,16(3)).
• Inner package and transportation outer. "Inner package" is an individual package contained and sold within another fully labelled package, not designed for individual sale other than by a responsible institution to its patients/residents. "Transportation outer" means outer packaging used for transportation; both have specific labelling regimes (Notes and 2.9.5,16 and 2.9.5,17).
• Majority seller. A person is a majority seller of a given FSMP over a rolling 24-month period if more than half of that person’s sales of the product in that period were to medical practitioners, dietitians, medical practices, pharmacies or responsible institutions (2.9.5,5(2), definition).
• Very low energy diet (VLED) and very low energy food. Note 4 (added in the VLED amendments) defines a very low energy diet as a range of FSMPs specially formulated for overweight/obesity management that provide the sole source of nutrition when consumed according to label directions. A very low energy food is a FSMP produced for consumption as part of a VLED (Note 4).
• Permitted forms and nutritive substances. Section 2.9.5,6 permits addition to FSMPs of substances listed in the Code’s tables S29,20 and S29,23, and other substances permitted elsewhere in the Code subject to those Code requirements; crucially, where the Code otherwise limits the amount of such substances, that limit "does not apply in relation to food for special medical purposes" (2.9.5,6(2).
• Compositional minima for sole-source use. Section 2.9.5,7 requires FSMPs represented as suitable for sole-source nutrition to meet minimum and, where applicable, maximum levels set out in the table to section S29,21 (2.9.5,7(1) and (3)). The Standard allows variations from those minima where a variation is required for a particular medical purpose, provided the labelling complies with 2.9.5,10(1)(g)(ii) (2.9.5,7(2)).
• Labelling and statements. Division 4 prescribes mandatory label content (2.9.5,9), including that labels must state the product be "used under medical supervision" (2.9.5,10(1)(a)); other required items include date marking, ingredient information, directions and nutrition info (2.9.5,9(1)(e)-(i)). Inner packages and transportation outers have pared-down mandatory label information (2.9.5,16 and 2.9.5,17).
• Claims constraints. Therapeutic claims are prohibited (2.9.5,4). Lactose and gluten content claims have narrowly defined permitted thresholds and required labelling information (2.9.5,14 and 2.9.5,15). Very low energy foods may not carry health claims (2.9.5,19).

These concepts function together: product classification (FSMP, VLED) triggers compositional and permitted-additive exemptions, which in turn require defined label statements and restrict the ways products may be marketed and sold. The Standard relies on cross-references to Code tables S29,20, S29,21 and S29,22 for specific nutrient lists and permitted forms; these tables are incorporated by reference and have been amended (for example substitution of S29,23 for S29,7, Amendment No. 231, 13 Sept 2024).

Who pays, who decides, and who must change behaviour flows directly from the Standard’s structure.

• Manufacturers and formulators. Entities producing FSMPs must ensure their products meet the FSMP definition (1.1.2,5) and comply with the compositional rules in Div 3. Where a product is represented as "suitable for use as a sole source of nutrition", manufacturers must meet the minimums in S29,21 unless a medical-purpose variation applies and is disclosed on the label (2.9.5,7(1)-(2)). Very low energy food producers must meet the compositional minima in 2.9.5,18 and must not make health claims about VLED products (2.9.5,18 and 2.9.5,19).
• Ingredient suppliers. The Standard permits addition of certain substances and forms set out in S29,20 and S29,23 to FSMPs (2.9.5,6(1)(a)-(b)). Suppliers and manufacturers need to confirm the form supplied is one of the permitted forms in those tables. Additionally, where the Code limits amounts of such substances elsewhere, the Standard suspends those limits in the FSMP context (2.9.5,6(2)), which affects formulation strategies and labelling.
• Distributors, pharmacies and medical practices. The sale restriction (2.9.5,5(1)) requires distributors to control the channels via which FSMPs reach consumers. Pharmacies, medical practices, registered medical practitioners and dietitians are authorised sellers. Responsible institutions may supply FSMPs directly to patients/residents. Organisations that are majority sellers (defined at 2.9.5,5(2)) also qualify to sell FSMPs directly to consumers. Businesses that previously sold similar products through general retail channels must change distribution arrangements unless they meet the majority seller test over a 24‑month window.
• Responsible institutions. Hospitals and aged care providers both distribute and receive special rules for inner packages. Where inner packages are supplied to patients/residents of a responsible institution, the inner-package labelling obligations continue to apply (2.9.5,16(3)). Responsible institutions that prepare, re-package or administer FSMPs must align with the Standard’s labelling and compositional rules.
• Clinicians (medical practitioners and dietitians). The Standard expects FSMPs to be "used under medical supervision" (2.9.5,10(1)(a)). Clinicians are therefore gatekeepers in practice: they prescribe or recommend use, they are sellers in the sense of being permitted to sell to consumers (2.9.5,5(1)(a)), and they may be the audience for the compositional and labelling disclosures that enable appropriate medical management.
• Regulators and compliance officers. The Standard is an instrument under the Food Standards Australia New Zealand Act 1991 and is applied within Australian states and territories and, via the Food Act 2014, in New Zealand (Notes 1 and 2). Regulators will need to align enforcement with state/territory food laws and the recorded transitional arrangements for each amendment. The Standard itself does not specify criminal or civil penalties; enforcement mechanisms derive from how the Code has been incorporated into domestic law and regulatory regimes.
• Marketers and in-house legal/compliance teams. Advertising, labelling and claims must avoid prohibited therapeutic, health and certain nutrient-content claims (2.9.5,4; 2.9.5,19; 2.9.5,14 and 2.9.5,15). Marketing materials and product information provided to clinicians must be drafted so the labelling mandated by the Standard is accurate, particularly where a product deviates from standard nutrient minima for a stated medical purpose (2.9.5,7(2) and 2.9.5,10(1)(g)(ii)).

Geographic and channel effects: the Standard applies throughout Australia and (by Note 2) in New Zealand where the Code is incorporated in domestic legislation. The transitional schedules mean that, for certain amendments, suppliers can sell products complying with either the prior or new requirements during stated transition windows (see the transitional tables for Items 197, 208 and 231). Those windows impose operational decisions about relabelling, re-packaging and stock rotation.

Concentrated burdens and benefits. The Standard concentrates compliance costs on specialised manufacturers, formulators and distributors that operate in clinical/medical channels and on institutions that supply FSMPs. Benefits,access to a regulated category with tailored compositional and additive exemptions,are concentrated among products able to meet FSMP definition and sell through permitted channels. Consumers obtain access to medically targeted nutritional products but only via restricted channels and under medical supervision as stated on the label (2.9.5,10(1)(a)).

State the statutory obligations and the explicit permissions the Standard confers; cite sections.

Duties (what regulated parties must do)

• Selling channel obligations. A provider must not sell an FSMP to a consumer except from or by: a medical practitioner or dietitian; a medical practice, pharmacy or responsible institution; or a person who is a majority seller of that FSMP (2.9.5,5(1)). Organisational actors must therefore control retail distribution and document sales channels to demonstrate compliance with the sales restriction.
• Labelling obligations. Where an FSMP is sold in a package, that package must bear a label complying with s 2.9.5,9 and Division 6 of Standard 1.2.1 (2.9.5,8(2), 2.9.5,9(3)). The label must include name/description (2.9.5,9(1)(a)), lot identification (2.9.5,9(1)(b)), required advisory/warning statements and declarations (2.9.5,9(1)(d)), ingredient information (2.9.5,9(1)(e)), date marking (2.9.5,9(1)(f); 2.9.5,12), directions and storage where necessary for health/safety (2.9.5,9(1)(g)), nutrition information (2.9.5,9(1)(h)) and, if applicable, very low energy food quantity information (2.9.5,9(2)).
• Mandatory statements on labels. The label must state that the food "must be used under medical supervision" (2.9.5,10(1)(a)). Labels must also indicate precautions/contraindications where applicable (2.9.5,10(1)(b)), the medical purpose and the properties making the food appropriate for that purpose (2.9.5,10(1)(c)-(d)), whether the food is intended for specific age groups (2.9.5,10(1)(e)), and whether it is suitable for sole-source nutrition (2.9.5,10(1)(f)). Additional statements are required if the food is represented as suitable for sole-source nutrition (2.9.5,10(1)(g)).
• Compositional duties for sole-source FSMPs. An FSMP represented as suitable for sole-source nutrition must contain no less than the minimum amounts and not exceed maxima (if applicable) specified in the table to section S29,21 for each vitamin, mineral and electrolyte listed (2.9.5,7(1)). Exceptions apply where a variation is necessary for a particular medical purpose and appropriately labelled (2.9.5,7(2)). Very low energy foods are exempt from s 2.9.5,7 (2.9.5,7(3)).
• VLED compositional duties. A very low energy food, when consumed per label directions, must yield an average energy intake between 1880 kJ/day and 3345 kJ/day, supply at least 50 g available carbohydrates and at least 50 g protein per day with protein quality equivalent to a PDCAAS of 1, supply specified linoleic and α‑linolenic acids and meet minimum nutrient amounts set in S29,22 (2.9.5,18(1)(a)-(f)). L‑amino acids listed in S29,20 may be added to very low energy foods only in amounts necessary to improve protein quality (2.9.5,18(2)).
• Nutrition information duties. For FSMPs that are not very low energy foods, the label must state minimum or average energy, minimum or average protein/fat/carbohydrate and amounts of any vitamins, minerals, electrolytes or nutritive substances used in the food (2.9.5,13(1)). For very low energy foods, required nutrition information is specified per serving and includes linoleic and α‑linolenic acids and substances listed in S29,22 (2.9.5,13(2)).

Rights and permissions (what the Standard permits)

• Ingredient/form allowances. The Standard permits addition of substances in forms listed in S29,20 and S29,23, and permits adding any substance that is otherwise permitted under the Code if added in accordance with the applicable Code requirement (2.9.5,6(1)(a)-(c). Importantly, where other Code provisions limit amounts of such substances, those limits "do not apply" to FSMPs (2.9.5,6(2)). That is an express permissive carve-out enabling formulations that would otherwise exceed general limits in the Code.
• Sales right for majority sellers. A person who is a "majority seller" of a particular FSMP across a 24‑month window has the right to sell that FSMP to consumers (2.9.5,5(1)(c) and definition at 2.9.5,5(2)). That right is conditional on the 24‑month sales mix test.
• Alternative ingredient-labelling pathways. The label may present ingredient information via a statement of ingredients or by complying with Articles 18-20 of EU Regulation 1169/2011 or with 21 CFR § 101.4 (2.9.5,11). This provides manufacturers operating in multiple markets with options for harmonising ingredient labelling.
• Inner-package labelling simplification. Inner packages inside a fully labelled outer package need only carry the pared-down information in 2.9.5,16 (name/description, lot id, certain declarations and date marking). That simplifies inner-package labelling for products sold within a labelled outer package or by a responsible institution to a patient/resident (2.9.5,16(1)-(3)).

Constraints and prohibitions

• Therapeutic and health claims. A claim that refers to prevention, diagnosis, cure or alleviation of disease, disorder or condition is prohibited for FSMPs (2.9.5,4). A health claim about a very low energy food is prohibited (2.9.5,19).
• Strict nutrient-claim thresholds for lactose and gluten. Lactose-free requires "no detectable lactose" and low-lactose is <=2 g lactose per 100 g (2.9.5,14(2)-(3)). Gluten-free requires no detectable gluten and no oats or oat products and no malted cereals or products (2.9.5,15(2)); low gluten is <=20 mg gluten per 100 g (2.9.5,15(3)). If such claims are made, the label must state the average quantity of the nutrient(s) per given quantity (2.9.5,14(4) and 2.9.5,15(5)).

Documentary duties. Where the product varies from compositional minima for a stated medical purpose, the label must identify modified nutrients and indicate whether each has been increased, decreased or eliminated, unless this information is provided in other documentation (2.9.5,10(1)(g)(ii)(A)-(B)).

Overall, the Standard places direct obligations on formulators and label designers, prescribes allowed ingredient forms with an express carving out of otherwise applicable quantity limits, restricts sales channels to medical/clinical routes or majority sellers, and imposes specific duties for VLEDs and claims about lactose and gluten.

The Standard itself contains no express penalty provisions or criminal sanctions. It is an instrument within the Australia New Zealand Food Standards Code (see Note 1: "This instrument is a standard under the Food Standards Australia New Zealand Act 1991 (Cth). The standards together make up the Australia New Zealand Food Standards Code"). Note 2 records that Code provisions that apply in New Zealand are incorporated in or adopted under the Food Act 2014 (NZ). Because the Standard is part of the Code, its legal enforceability depends on domestic incorporation and enforcement mechanisms in states, territories and New Zealand.

Consequence and enforcement mechanics that follow from the source text

• No penalty clauses in the Standard. The Standard sets rules and obligations but does not specify penalty quantum or enforcement procedure. The compilation explicitly lists amendments and transitional provisions but does not attach infringement or criminal penalty schedules to the Standard text itself.
• Enforcement is administered through the Code’s legal framework. The Code is made under the Food Standards Australia New Zealand Act 1991. Enforcement and penalties for non‑compliance typically arise under state and territory food acts (in Australia) and the Food Act 2014 (in New Zealand) where the Code is given effect. The Standard cross-references provisions of the Code (for labelling, ingredients, etc.), which are usually enforced under domestic food safety laws. The Standard’s own notes indicate its status as a standard under the Act (Notes 1 and 2).
• Transitional tolerance windows. For practical compliance, the amendment schedules create explicit transition windows during which products complying with either the Code as in force before the variation or the Code as amended may be sold (see the tables for Items 197, 208 and 231). These transitional provisions function as temporary enforcement tolerances: for example, the VLED Variation (Item 208) established a transition period from 1 June 2022 to 1 June 2025 during which either old or new-compliant products could be sold; Item 197 provided a transition period beginning 25 February 2021 and ending 25 February 2024 with an additional post-transition sale allowance to 26 February 2026 in some cases; Item 231 sets a transition period from 13 September 2024 to 13 September 2029. During these periods, regulators are to accept products complying with either regime for sale (see the application and transitional tables).
• Practical enforcement focus. Regulators will typically examine whether a product fits the FSMP definition (1.1.2,5), whether labelling bears the mandatory statements (2.9.5,9 and 2.9.5,10), whether claims are prohibited (2.9.5,4 and 2.9.5,19), whether lactose/gluten claims meet thresholds (2.9.5,14 and 2.9.5,15), and whether sales channels comply with 2.9.5,5. Where the Standard permits ingredient additions beyond general Code limits (2.9.5,6(2)), regulators will focus on whether such additions are appropriate to the medical purpose and correctly declared on the label.

Compliance assurance and recordkeeping. Because a "majority seller" status depends on a 24‑month sales assessment (2.9.5,5(2)), businesses must maintain records that demonstrate their sales composition. Likewise, claims such as "no detectable gluten" or "lactose free" carry an implicit lab-testing expectation; the Standard requires that labels include "average quantity" information when claims are made (2.9.5,14(4); 2.9.5,15(5)), which implies recordkeeping on analysis.

Limitations in the source. The Standard does not set out enforcement penalties, administrative fines or prosecution thresholds. Those are matters for the state/territory or national enforcement frameworks that give effect to the Code. The Standard itself, and the amendment tables included, serve to set product/label requirements and transitional tolerances; specific sanctioning regimes must be sought in the domestic legislation that enforces the Code.

The Standard is embedded in the Code and cross-references numerous other Code provisions; its legal effect therefore depends on these cross-links and on domestic food legislation.

Cross-references inside the Code

• Definition cross-reference. The FSMP definition is provided by section 1.1.2,5 and is reproduced in Note 1 to the Standard. Users must check 1.1.2,5 for the precise definitional threshold used throughout the Code (Note 1).
• Labelling frameworks. The Standard repeatedly cross-references the Code’s general labelling rules. For example, a label for an FSMP is required to comply with Division 6 of Standard 1.2.1 (2.9.5,9(3); 2.9.5,16(2)). It also references section 1.2.2,2 (name/description), 1.2.2,3 (lot identification), and 1.2.2,4 (supplier name and address) for particular labelling elements (2.9.5,9(1)(a),(b) and see 2.9.5,17(2)(c)). Required advisory, warning statements and declarations are cross-referenced to S9,2 and sections 1.2.3,2 and 1.2.3,4 (2.9.5,10(2)).
• Carve-outs from other standards. Section 2.9.5,3 expressly states that certain Code provisions do not apply to FSMPs: paragraphs 1.1.1,10(6)(b) and (f) (foods used as nutritive substances and novel foods) are excluded, and unless a contrary intention appears, Part 1.2 labelling and other information requirements do not apply (2.9.5,3(a)-(b)). The Standard also states that Standards 2.9.2 (food for infants), 2.9.3 (formulated meal replacements and formulated supplementary foods), and 2.9.4 (formulated supplementary sports foods) do not apply to FSMPs (2.9.5,3(c)). These carve-outs channel FSMPs into their own regime while isolating them from some general Code constraints.
• Reference to S29 tables. The Standard permits certain substances in specific forms as listed in S29,20 and S29,23 (2.9.5,6). Compositional minima for sole-source FSMPs are set by S29,21 (2.9.5,7) and nutrient minima for VLEDs are specified in S29,22 (2.9.5,18(1)(f)). The Standard therefore relies on those S29 tables to deliver precise numeric requirements and permitted forms.

International labelling routes

• Ingredients and labelling. Section 2.9.5,11 permits the ingredient information requirement to be satisfied by a statement of ingredients or by compliance with Articles 18-20 of EU Regulation 1169/2011 or 21 CFR § 101.4 (the U.S. FDA ingredient standard). This gives manufacturers operating in multiple jurisdictions an alternative compliance pathway for ingredient listing.

Domestic incorporation and enforcement

• Status under national and subnational law. The Standard is made under the Food Standards Australia New Zealand Act 1991 and forms part of the Code (Note 1). Application in New Zealand occurs via the Food Act 2014 (NZ) (Note 2). Enforcement of these Code obligations, and the imposition of penalties for breaches, relies on how the Code is adopted into state/territory (Australia) and national (New Zealand) food legislation. The Standard itself does not specify enforcement mechanisms; those are determined by the domestic food safety/consumer protection statutes that give effect to the Code.

Transitional interactions and regulatory grace periods

• Amendment transition rules. The Standard’s amendment history includes explicit transitional arrangements for specific variations (see the application tables). These transitional rules permit sale of products complying with either the pre-variation or post-variation Code for the stated transition period (for example Items 197, 208 and 231). Regulators and companies must therefore interpret compliance obligations in light of these windows,particularly relevant for labelling and compositional changes.

Operational frictions at interfaces

• Sales channel vs consumer law. The Standard restricts the retail channel for FSMPs (2.9.5,5). That interacts with consumer protection laws and pharmacy regulation because the permitted sellers include pharmacies and medical practices. Companies used to general retail channels must align with professional regulation and supply-chain controls.
• Conflicts and consistency checks. Because the Standard removes certain restraints in other Code provisions (for instance, lifting other Code limits on specified substances added to FSMPs per 2.9.5,6(2)), manufacturers must ensure that such deviations are consistent with domestic health, medicines and scheduling laws; in some cases, an ingredient permitted for food use in the FSMP regime might also be captured by medicines, poisons or therapeutic goods regulation depending on form, dose or representation. The Standard’s prohibition on therapeutic claims (2.9.5,4) helps to draw the line, but parties should check overlaps with therapeutic goods regulation in Australia and medicines regulation in New Zealand.

In short, the Standard’s legal effect depends on its cross-references to other Code provisions and to domestic adoption of the Code. It creates carve-outs from some general Code rules, substitutes specialised compositional and labelling rules, and provides transitional tolerances for named amendments. Users must therefore read the Standard in tandem with the referenced Code sections and with the domestic laws under which the Code is enforced.

The compilation provided is No. 5 of Standard 2.9.5 as in force on 13 September 2024 (up to Amendment No. 231). The Standard was originally published in the Food Standards Gazette No. FSC96 on 10 April 2015 as part of Amendment 154 and commenced on 1 March 2016. The compilation includes commenced amendments to that date. Relevant amendments and their mechanical effects recorded in the compilation include the following notable items.

• Amendment No. 157 (Sept 2015): Section 2.9.5,3 amended to remove a reference to Standard 1.1A.2 (commencement 1 March 2016). This was an early correction to cross-references.
• Amendment No. 161 (Feb 2016): Corrected a reference to Part 1.2 (commencement 1 March 2016).
• Amendment No. 168 (13 April 2017): Repealed and substituted section 2.9.5,3 to correct cross-references; and amended 2.9.5,11 to update a reference (commencement 13 April 2017).
• Amendment No. 197, Food Standards (Proposal P1044 - Plain English Allergen Labelling) Variation (FRL F2021L00145; Gazette 25 Feb 2021): Amended paragraph 2.9.5,9(1)(d) to include "declarations", and amended the heading and paragraph 2.9.5,10(2) to include "declarations" (commencement 25 Feb 2021). Clause 4 of that instrument established transitional arrangements: a transition period from 25 February 2021 to 25 February 2024, and a post-transition period from 26 February 2024 to 26 February 2026 for products packaged and labelled before the end of the transition period; during transition regulators accept products compliant with either regime.
• Amendment No. 208, Food Standards (Application A1230 - Very Low Energy Diets (VLED)) Variation (FRL F2022L00733; Gazette 1 June 2022): Amended several parts of the Standard including Note 1 and added Note 4; added subsection 2.9.5,7(3); repealed and substituted 2.9.5,9(2) and (3); amended 2.9.5,10(1)(g)(ii); added 2.9.5,10(1)(h); repealed and substituted 2.9.5,13; and added sections 2.9.5,18 and 2.9.5,19 (commencement 1 June 2022). Clause 4 provided a transition period from 1 June 2022 to 1 June 2025, during which products complying with either the prior Code or the amended Code could be sold.
  • The VLED variation codified the definitions of very low energy diet and very low energy food (Note 4), added compositional requirements for very low energy diets (2.9.5,18), restricted L‑amino acid additions to necessary amounts (2.9.5,18(2)), and prohibited making health claims for very low energy foods (2.9.5,19).
• Amendment No. 231 (FRL F2024L01151; Gazette 13 Sept 2024): Repealed and substituted section 2.9.5,6(1)(b), replacing a reference to "section S29,7" with "section S29,23" (commencement 13 Sept 2024). This amendment updated the S29 table cross-reference used for permitted substance forms. Item 231 also established a transitional period from 13 September 2024 to 13 September 2029 during which products could be sold compliant with either the prior or new regime.

Transitional detail and practical effect

• Transition windows. The amendment records emphasise that for each variation the Code’s usual operation (section 1.1.1,9) may not apply, and that for the duration of the stated transition periods, products compliant with either the pre-variation or post-variation Code may be sold. Examples: Item 197 transition 25 Feb 2021-25 Feb 2024 (post-transition allowance to Feb 2026 for pre-labelled stock); Item 208 transition 1 June 2022-1 June 2025; Item 231 transition 13 Sept 2024-13 Sept 2029. These windows are contractual in effect and materially affect supply-chain decisions such as relabelling and sale of existing inventory.
• Table-driven compositional changes. Several amendments adjust cross-references to S29 tables or add new compositional requirements tied to those tables (for example S29,21 for sole-source nutrients and S29,22 for VLEDs). Item 231’s substitution of S29,23 for S29,7 (13 Sept 2024) alters which permitted forms of substances are available for FSMPs; manufacturers must reconcile these catalogue changes with their formulations.
• Administrative history. The compilation records that it was prepared by Food Standards Australia New Zealand on 13 September 2024 and that it incorporates amendments up to that date. It also notes that uncommenced amendments or provisions ceasing to have effect may be reflected in the Standard as shaded boxed text in separate compilations registered on the Federal Register of Legislation.

In short, the amendment history shows iterative refinement of cross-references, the addition of a distinct VLED regime (composition and claim prohibition), updates to allergen/declaration labelling, and an S29 table substitution in 2024. Each change carries an explicit transition window that permits dual-regime sales for stated periods.

The Standard compilation and the accompanying amendment tables do not record any judicial decisions or litigation history. The instrument text and its amendment history do not cite cases, regulatory prosecutions, administrative determinations or tribunal decisions. The document itself therefore provides no jurisprudential history or precedent tied to the interpretation or enforcement of Standard 2.9.5.

Practical implications of the absence of litigation references

• No internal case law in the compilation. Because the compilation does not include litigation references, users must look to external sources,state and territory food regulators’ enforcement records, administrative tribunal decisions, and court reports,to assess how the Standard has been interpreted in enforcement actions.
• Enforcement likely administered under other statutes. Enforcement actions that give rise to litigation would ordinarily be brought under the domestic statutes that incorporate the Code (for example state food acts in Australia or the Food Act 2014 in New Zealand). Parties seeking precedent on compliance or interpretation should therefore identify cases arising under those domestic frameworks rather than expecting litigation reported in the Standard compilation itself.
• Areas likely to generate disputes. Based on the Standard’s content, likely themes for regulatory disputes (if they arise) include: whether a product meets the FSMP definition (Note 1 and 1.1.2,5), whether a product is incorrectly represented as a sole-source FSMP without meeting S29,21 minima (2.9.5,7), whether permitted additions under S29,20/S29,23 have been correctly applied and disclosed (2.9.5,6), whether a majority seller qualification has been properly calculated (2.9.5,5(2)), and whether labelling and claim rules (including prohibitions on therapeutic and health claims) have been breached (2.9.5,4; 2.9.5,19). These are logical hotspots for potential regulatory action, though no cases are referenced in the Standard itself.

Recommendation for practitioners researching litigation. To find enforcement decisions or court treatment, search: (a) state/territory food regulator enforcement and adjudication records; (b) tribunal decisions relating to food labelling and therapeutic/health claims; (c) prosecutions referencing the Food Standards Code as incorporated into domestic law; and (d) decisions about the interface between foods regulated as FSMPs and therapeutic goods/medicines regulation. The Standard compilation provides the statutory text and amendment history but not the interpretive record.

The Standard contains several provisions that can cause unexpected compliance outcomes. These are operational frictions and legal traps that practitioners and compliance teams should watch.

1. Sales-channel restriction and the "majority seller" test (2.9.5,5).

   • Trap: A business used to selling nutritional or therapeutic-type products through general retail channels cannot simply treat an FSMP as another retail product. FSMPs "must not be sold to a consumer" except from or by specified medical channels or a person who meets the majority seller test (2.9.5,5(1)). The majority seller test is retrospective: over any 24‑month period, if more than 50% of a person’s sales of that FSMP were to medical practitioners, dietitians, medical practices, pharmacies or responsible institutions, they qualify (2.9.5,5(2)). A company that does not maintain clear sales records can be exposed if regulators test channel compliance or challenge its status.
   • Operational consequence: keep granular sales ledgers by customer class and period; assess distribution channels before marketing directly to consumers.

2. Inner package vs outer package labelling (2.9.5,8(3) and 2.9.5,16).

   • Trap: Where products are sold within a fully labelled outer, inner packages need only limited information (2.9.5,16). But if an inner package is later supplied by a responsible institution to a patient, the inner-package labelling obligations continue to apply (2.9.5,16(3)). A manufacturer or institution that repackages or distributes inner packs separately may run afoul of labelling duties if it assumes outer-package labelling absolves inner-package duties.
   • Operational consequence: track how inner packs will be supplied and ensure inner packs meet 2.9.5,16 at time of eventual supply.

3. The compositional carve-out for FSMPs (2.9.5,6(2)).

   • Trap: Section 2.9.5,6(2) states that where the Code otherwise limits the amount of a permitted substance, that limit "does not apply in relation to food for special medical purposes." That is a broad permission. However, removing one Code limit does not immunise a product from other regulatory regimes such as medicines scheduling, poisons laws or therapeutic goods regulation where relevant. A manufacturer relying on 2.9.5,6(2) to exceed general food limits must still check other statutory regimes.
   • Operational consequence: perform a cross‑regulatory compliance check before formulating higher doses of substances that are otherwise limited in general foods.

4. VLED compositional specifics and labelling interaction (2.9.5,18 and 2.9.5,19).

   • Trap: Very low energy foods are excluded from the sole-source nutrient minima in 2.9.5,7(3) but are subject to 2.9.5,18’s specific energy window, macronutrient minima, essential fatty acid minima and ratio, and S29,22 micronutrient minima. In addition, health claims are prohibited for very low energy foods (2.9.5,19). Misreading the exclusions can lead to incorrect labelling or composition,for instance attempting to make a health claim about weight-loss properties on a VLED label would be prohibited.
   • Operational consequence: for VLED products ensure the formulation and the label (including recommended daily quantity per 2.9.5,9(2)) both comply; avoid health claims.

5. Narrow thresholds for lactose and gluten claims (2.9.5,14; 2.9.5,15).

   • Trap: "Gluten free" requires no detectable gluten and also no oats or oat products, and no malted cereals or products of such cereals (2.9.5,15(2)). "Low gluten" is ≤20 mg gluten/100 g (2.9.5,15(3)). "Lactose free" requires "no detectable lactose" and "low lactose" is ≤2 g/100 g (2.9.5,14(2)-(3)). Some suppliers assume "gluten free" only requires ≤20 mg/kg (EU standard); whereas here the Standard requires "no detectable gluten" and no oats,this is stricter. Also gluten testing sensitivity and the "no oats" prohibition create formulation constraints.
   • Operational consequence: obtain and retain analytical test records supporting any "no detectable" claim, ensure raw material supply chains avoid oats or malted cereals for a gluten-free claim, and include average quantity statements when claims are made (2.9.5,14(4); 2.9.5,15(5)).

6. Labelling tolerances and alternate compliance pathways (2.9.5,11).

   • Trap: The Standard permits ingredient information to comply with EU Articles 18-20 or 21 CFR §101.4 as alternatives to a statement of ingredients (2.9.5,11). A manufacturer that uses an EU or US format must ensure its label still meets the local mandatory statements in 2.9.5,9 and the Division 6 requirements of Standard 1.2.1 (2.9.5,9(3)). Using a foreign format does not excuse omission of the FSMP-specific mandatory statements (for example "must be used under medical supervision" required by 2.9.5,10(1)(a)).
   • Operational consequence: harmonise label templates carefully; do not substitute an EU/US ingredients presentation for FSMP mandatory statements.

7. Transitional windows create inventory and relabelling complexity.

   • Trap: Amendment transition windows (Items 197, 208, 231) permit sale of pre-existing stock for a stated period (e.g., Item 208: 1 June 2022 to 1 June 2025). Mis-timing relabelling or disposal of stock can create non-compliance after the transition window closes.
   • Operational consequence: map labelling and inventory timelines to the amendment transition windows and plan relabelling or sell-through accordingly.

8. Therapeutic claim prohibition vs medical representation (2.9.5,4).

   • Trap: The Standard prohibits claims that refer to "prevention, diagnosis, cure or alleviation of a disease, disorder or condition" (2.9.5,4). However, FSMPs are to be "represented as being for the dietary management of a disease, disorder or medical condition" under the FSMP definition (1.1.2,5(1)(c)). The distinction is the Standard allows representation as intended for dietary management under medical supervision but prohibits claims that would amount to therapeutic assertions about preventing or curing disease. Distinguishing permissible medical-purpose representation from impermissible therapeutic claims requires careful drafting.
   • Operational consequence: labels and promotional materials should emphasise dietary management under supervision and describe properties that make the food appropriate for that purpose without asserting prevention/cure claims.

These "gotchas" flow from the text. Where risk exists that a formulation or label could overlap with therapeutic regulation or other statutory regimes, parties should undertake a cross‑regulatory check because the Standard does not immunise a product from non‑food statutory regimes.

This section sets out practical, source-grounded steps and checkpoints for manufacturers, distributors, responsible institutions and clinicians to align with Standard 2.9.5. It assumes reading the exact text and the S29 tables referenced by the Standard.

1. Confirm product classification

   • Read and apply the FSMP definition at 1.1.2,5 (reproduced in Note 1). Verify the product is "specially formulated" for dietary management of medically determined nutrient requirements or functional limitations in digestion/absorption, that dietary management "cannot be completely achieved without the use of the food", and that it is "intended to be used under medical supervision" and is represented as such (Note 1(1)(a)-(c)).
   • Confirm exclusions: the product is not an infant formula product and is not a food formulated for overweight/obesity management unless it is a "very low energy food" (Note 1(2)).

2. Decide and document sales channels

   • If you intend to sell to consumers, ensure sales occur only via permitted channels: medical practitioners/dietitians, medical practices, pharmacies, responsible institutions, or by an entity qualifying as a "majority seller" for that FSMP under 2.9.5,5(2).
   • Maintain sale records by customer class for rolling 24‑month periods to support a majority seller claim. Ensure invoices and customer categorisation permit ready audit.

3. Compositional compliance and permitted additions

   • For FSMPs represented as suitable as a sole source of nutrition, check S29,21 for minimums and maxima and ensure your formula meets the table requirements (2.9.5,7(1)).
   • If the product is a very low energy food, ensure it meets the compositional criteria in 2.9.5,18: energy range 1880-3345 kJ/day, ≥50 g available carbohydrate, ≥50 g protein/day with PDCAAS = 1, essential fatty acid minima and ratio, and S29,22 micronutrient minima (2.9.5,18(1)(a)-(f)). Limit additions of L‑amino acids to amounts necessary to improve protein quality (2.9.5,18(2)).
   • Where you intend to include substances listed in S29,20 or S29,23, ensure the specific form you use appears in Column 2 of those tables (2.9.5,6(1)(a)-(b)). Note that 2.9.5,6(2) removes certain Code quantity limits for such substances in FSMPs,nevertheless, document the medical rationale for the chosen levels and check for non-food regulatory overlap.

4. Labelling and mandatory statements

   • For packaged FSMPs, ensure labels contain the items in 2.9.5,9(1): name/description (1.2.2,2), lot id (1.2.2,3), required advisory/warning statements and declarations (2.9.5,10; cross-ref S9,2 and 1.2.3 rules), ingredient information (2.9.5,11), date marking per Standard 1.2.5 (2.9.5,12), directions for use/storage where necessary (2.9.5,9(1)(g)), nutrition information per 2.9.5,13, and any additional info required by inner-package or transportation-outer rules (2.9.5,16 and 2.9.5,17).
   • Add the mandatory statement "must be used under medical supervision" (2.9.5,10(1)(a)). If the product is to be used as a sole source, include the required statements (2.9.5,10(1)(g)), including statements identifying any modified nutrients and whether they are increased, decreased or eliminated (2.9.5,10(1)(g)(ii)(A)-(B)), unless that information is in other documentation.
   • For very low energy foods, state the recommended daily quantity of all very low energy foods to be consumed in order to provide the sole source of nutrition (2.9.5,9(2)) and include the additional statements required by 2.9.5,10(1)(h) (adequate fluid, not for pregnant/nursing/infants/children/adolescents/elderly except under medical supervision, and suitability as sole-source when consumed per directions).

5. Nutrition information and claims

   • For non-VLED FSMPs, include nutrition information per 2.9.5,13(1): minimum or average energy and minimum or average protein/fat/carbohydrate and specified vitamin/mineral/electrolyte and nutritive substance amounts. For VLEDs, include the per-serving nutrition data mandated by 2.9.5,13(2).
   • Do not make therapeutic claims referring to prevention, diagnosis, cure or alleviation of disease (2.9.5,4). Do not make health claims for very low energy foods (2.9.5,19).
   • For lactose and gluten claims, follow the thresholds in 2.9.5,14 and 2.9.5,15: "lactose free" = no detectable lactose; "low lactose" ≤2 g/100 g; "gluten free" = no detectable gluten and no oats/oat products or malted cereals/products; "low gluten" ≤20 mg gluten/100 g. When a claim is made, include average quantity information per 2.9.5,14(4) and 2.9.5,15(5).

6. Ingredient listing options

   • Provide ingredient information either as a statement of ingredients or follow EU Articles 18-20 (Reg 1169/2011) or U.S. 21 CFR §101.4 (2.9.5,11). Regardless of format, ensure FSMP mandatory statements and Division 6 of Standard 1.2.1 requirements are present (2.9.5,9(3)).

7. Inner packages and transportation outers

   • If the product uses inner packages inside a fully labelled outer, ensure inner packages carry name/description, lot id, any declaration required by 1.2.3,4 and date marking (2.9.5,16(1)). For transportation outers, either the outer or a package visible through the outer must show name/description, lot id and supplier name/address unless supplied in accompanying documentation (2.9.5,17).

8. Recordkeeping and testing

   • Maintain analytical evidence for any "no detectable" claims (gluten/lactose) and average quantity calculations used on labels (2.9.5,14(4); 2.9.5,15(5); 2.9.5,13). Keep retention of test results, method detection limits and chain-of-custody.
   • Maintain sales records by customer type for the 24‑month majority seller calculation (2.9.5,5(2)). Preserve documentary evidence showing that a product is used under medical supervision, such as clinician prescriptions or institution purchasing protocols.

9. Assess cross-regulatory risks

   • Before exceeding other Code limits under 2.9.5,6(2), check for interactions with medicines, therapeutic goods, poisons and scheduling laws. A high-dose nutrient or bioactive substance might attract regulation as a therapeutic good depending on representation, formulation and dose, even where the FSMP Standard permits higher amounts.
   • Engage regulators or legal counsel where there is doubt about overlaps with therapeutic goods regulation.

10. Track amendments and transitional windows

• Map product labelling and stock to the transition windows noted in the amendment tables. For example: Item 208 (VLED Variation) transition 1 June 2022-1 June 2025; Item 197 transition 25 Feb 2021-25 Feb 2024 with post-transition sale allowances; Item 231 transition 13 Sept 2024-13 Sept 2029. During those windows regulators accept products complying with either the old or new Code. Plan relabelling, sell-through and inventory disposal accordingly.

11. Practical label drafting checklist (minimum)

• Prominent statement: "To be used under medical supervision" (2.9.5,10(1)(a)).
• Medical purpose and describing properties (2.9.5,10(1)(c)-(d)).
• Date marking per Standard 1.2.5 (2.9.5,12).
• Ingredient statement or EU/US-compliant alternative (2.9.5,11).
• Nutrition information per 2.9.5,13.
• Lactose/gluten claim wording consistent with 2.9.5,14 and 2.9.5,15.
• For VLEDs: recommended daily quantity and the 2.9.5,10(1)(h) advisory statements.

12. Consult regulators early for borderline products

• Where classification is uncertain (e.g., products that straddle FSMP and formulated meal replacements or therapeutic goods) consult FSANZ advice or state/territory food regulators. The Standard excludes certain other Standards (2.9.5,3(c)), so confirm the correct product class before launching.

Following these steps, with detailed documentary evidence for sales composition, analytical testing and formulation rationales, will materially reduce compliance risk. The Standard’s cross-references to S29 tables mean practitioners should consult those tables for precise numeric obligations, and monitor amendment instruments (Items 197, 208, 231) and their transition windows when planning labelling and inventory actions.