Food Standards (Application A1230 – Very Low Energy Diets (VLED)) Variation

The instrument introduces two defined terms. A very low energy diet (VLED) is a range of food for special medical purposes that is specially formulated for the dietary management of overweight and obesity and which provides the sole source of nutrition when consumed according to the label directions. A very low energy food (VLF) is a food for special medical purposes produced for consumption as part of a VLED. The definition deliberately ties the diet to the concept of a “range” of foods (plural) that together supply total nutrition, not a single meal replacement. The energy range is prescribed: no less than 1880 kJ per day and no more than 3345 kJ per day when consumed as directed. That is roughly 450‑800 kcal, consistent with international definitions of very low calorie diets. The composition must include at least 50 g of available carbohydrates and 50 g of protein with a protein digestibility corrected amino acid score (PDCAAS) of 1, plus specific minimum amounts of linoleic acid (3 g), α‑linolenic acid (0.5 g), and a linoleic‑to‑α‑linolenic ratio between 5 and 15. The instrument also adopts a table in new section S29‑22 that sets minimum daily intakes for vitamins (A, D, E, C, B6, B12, niacin, riboflavin, thiamin, folic acid) and minerals (calcium, phosphorus, iron, iodine, magnesium, copper, zinc, potassium, sodium). These are mandatory for each daily intake of the diet. Another key concept is that VLED foods are exempt from the general prohibition under subsection 2.9.5‑7(1) (the exact content of that prohibition is not fully reproduced in the instrument, but the exemption is explicit). They are also excluded from the health‑claim regime: section 2.9.5‑19 prohibits any health claim about a VLED food. This means that even if a VLED food meets the scientific criteria for a health claim under Standard 1.2.7, it cannot be labelled or advertised with such a claim. The category also removes the possibility for VLED foods to use the general FSMP labelling exemptions found in section 2.9.5‑9(2) (which formerly allowed “serve” or “daily intake” labelling without specifying the sole‑source role). Now VLED labels must state the recommended daily quantity of all VLED foods to be consumed to provide the sole source of nutrition, and must also carry warnings about not being suitable for pregnant, nursing, or lactating women, or for infants, children, adolescents, and the elderly except under medical supervision, and a statement urging adequate fluid intake.

The variation directly affects any business that manufactures, imports, or distributes a food product intended for use as a total meal replacement for weight‑reduction purposes. This includes companies that previously relied on the FSMP classification for their meal replacement shakes, bars, soups, or powders. The new rules also affect retailers and online sellers because they must ensure that any VLED product they stock complies with the amended labelling requirements before the end of the transition period. Healthcare professionals who prescribe or recommend VLED products (such as dietitians and obesity‑medicine specialists) may need to update their knowledge of the regulatory status and the required advisory statements to give accurate advice to patients. Consumers who purchase these products should be aware that only products meeting the VLED definition can now be marketed as FSMP for weight loss; other weight‑management foods are now ordinary food, with potentially less regulated nutrient profiles. The variation also indirectly affects manufacturers of non‑VLED weight‑loss products that were previously sold as FSMP. Those products must now be reformulated or relabelled to comply with general food standards, or else be withdrawn from the market. Importers of international meal‑replacement brands will need to check whether their formulations match the Australian mandatory minimum nutrient levels (especially for linoleic acid, α‑linolenic acid, and the listed vitamins and minerals). If they do not, the product cannot lawfully be sold as a VLED and may not be sold as an FSMP at all. State and territory food enforcement agencies are affected because they must now enforce a distinct set of rules for this narrow category. The transition period of 36 months from gazettal (ending 1 June 2025) gives businesses time to adjust, but enforcement action could still be taken against products that do not comply after that date. The variation does not apply to infant formula products (excluded by the amended subsection 1.1.2‑5(2)), so manufacturers of infant formula are not directly affected. Similarly, the instrument does not affect products that are not specially formulated for the dietary management of overweight and obesity; it only targets those that claim such a purpose.

Manufacturers and suppliers of VLED foods have a set of positive duties imposed by the amended Code. First, they must ensure that when the food is consumed according to the manufacturer’s directions the diet falls within the prescribed energy range (1880‑3345 kJ/day) and meets all the compositional requirements in section 2.9.5‑18. That means the VLED must contain at least 50 g available carbohydrate, 50 g protein with a PDCAAS of 1, the specified fatty acids, and all nutrients at or above the minima in table S29‑22. The L‑amino acid rule in subsection 2.9.5‑18(2) restricts the addition of free amino acids to the amount necessary to improve protein quality, overriding the general permission in subsection 2.9.5‑6(2) that allows broader use of L‑amino acids in FSMP. Second, the label must state the recommended daily quantity of all VLED foods to be consumed to achieve sole‑source nutrition (new subsection 2.9.5‑9(2)). It must also include three advisory statements: maintain adequate fluid intake; not recommended for pregnant, nursing, or lactating women or for infants, children, adolescents, and the elderly (except under medical supervision); and a statement that the food is suitable as a sole source of nutrition when used as directed (new paragraphs 2.9.5‑10(1)(h)(i)‑(iii)). Third, the nutrition information panel must comply with new subsection 2.9.5‑13(2), which requires the average quantity per serving, average energy per serving, and minimum amounts or average quantities per serving of protein, fat, carbohydrate, linoleic acid, α‑linolenic acid, and any other vitamin, mineral, electrolyte, or substance used as a nutritive substance or for which a nutrition content claim is made. Fourth, a total prohibition on health claims applies: a health claim must not be made about a VLED food (section 2.9.5‑19). This removes the possibility of making any function claim or disease‑risk‑reduction claim, even if the product technically qualifies under Standard 1.2.7. The positive right that businesses have is to sell VLED products under the new regulatory framework, provided they meet the requirements. They also retain the right to sell non‑VLED weight management foods as ordinary foods, but those products cannot be labelled or marketed as FSMP. During the transition period, a food product may comply with either the old Code or the amended Code (clause 4(2)). This gives manufacturers the flexibility to sell existing stock without immediate reformulation, but also allows early adopters to use the new rules.

The instrument itself does not specify penalties. Enforcement occurs under the broader food regulatory system in Australia and New Zealand. In Australia, the Food Standards Code is enforced by state and territory food safety authorities under their respective food acts (e.g., the Food Act 2003 (NSW) or the Food Act 1984 (Vic)). Penalties for selling food that does not comply with the Code can include fines, injunctions, and product recall orders. The maximum penalty for a contravention of a standard under most state food acts is typically 1000‑2000 penalty units for a body corporate and lower for individuals (a penalty unit in 2025 is $313, so fines can exceed $300,000). In New Zealand, the Food Act 2014 and the Australia New Zealand Joint Food Standards Agreement apply, and penalties for non‑compliance can include fines up to NZ$500,000 for a body corporate. Although the instrument does not create a specific offence, it changes the standards against which compliance is measured. For example, if a manufacturer sells a product as a VLED that does not meet the energy or nutrient requirements, it may be prosecuted for selling food that does not comply with the Code. Similarly, making a health claim on a VLED food after the end of the transition period would be a breach. The prohibition on health claims is absolute; no defence of reasonable reliance on scientific evidence is available. The enforcement risk is heightened for products that straddle the line between VLED and ordinary FSMP. The old subsection 2.9.5‑9(2) required FSMP to state either “serve” or “daily intake”; the new version requires VLED foods to state a recommended daily quantity. A product labelled under the old rules may have a transition‑period grace, but after that it must be relabelled. Because the instrument is a variation to the Code, it is automatically enforceable by the same mechanisms that apply to all other Code standards. No additional administrative scheme is established.

This variation operates within the Australia New Zealand Food Standards Code. It amends Standard 1.1.2 (Definitions used throughout the Code), Standard 2.9.5 (Food for Special Medical Purposes), Standard 2.9.6 (Transitional standard for special purpose foods), and Schedule 29 (Special Purpose Foods). It also cross‑references Standard 1.2.1 (Labelling and information) because new subsection 2.9.5‑9(3) requires the label to comply with Division 6 of that Standard (which covers country‑of‑origin labelling). The variation does not amend Standard 1.2.7 (Nutrition, health and related claims), but it overrides it in part: section 2.9.5‑19 prohibits health claims on VLED foods, meaning that even if a VLED food meets the conditions in Standard 1.2.7 for a health claim, it cannot make one. This creates a hierarchy where the FSMP standard takes priority. The variation also interacts with the general prohibition on misleading or deceptive conduct under the Australian Consumer Law (Sch 2 of the Competition and Consumer Act 2010). A product that is labelled as a VLED but does not meet the compositional requirements may be considered misleading, and the ACCC could take action separately from food enforcement. In New Zealand, similar provisions exist under the Fair Trading Act 1986. The variation does not affect the Therapeutic Goods Act 1989 or the regulation of medicines. A VLED product that makes therapeutic claims (e.g., “treats obesity”) might be captured as a therapeutic good and require approval from the TGA. However, the prohibition on health claims in the Food Standards Code may reduce the risk of such products being classified as medicines, because they cannot make any health claims. The interaction with Standard 2.9.6 (Transitional standard) is explicit: a provision of that standard ceases to have effect in relation to a VLED food three years after commencement. That means any transitional exemptions for outdated requirements will no longer apply to VLED foods after June 2025. The exclusion of non‑VLED weight management foods from the definition of FSMP means that those products are now governed solely by the general food standards (e.g., Standard 2.9.1 for formulated meal replacements? Actually Standard 2.9.1 is for infant formula; meal replacements for weight loss are not specifically covered elsewhere, so they fall under general compositional requirements and labelling rules). This may create a gap: there is no mandatory nutrient minimum for ordinary weight‑loss products, which could lead to significant variation in quality.

This instrument is a variation to the Australia New Zealand Food Standards Code made under section 92 of the Food Standards Australia New Zealand Act 1991. It was gazetted on 1 June 2022 (Food Standards Gazette No. FSC 148). It is the first time the Code has contained a specific definition and requirements for very low energy diets. Before this variation, VLED products were regulated as food for special medical purposes under the general FSMP provisions in Standard 2.9.5, without any unique compositional or labelling rules. The application was assigned number A1230 and went through the standard FSANZ assessment process (including public consultation). There is no indication in the instrument of any earlier amendments to the same provisions; this is a standalone change. The instrument itself does not amend any other Act or regulation outside the Code. It is a legislative instrument of the Commonwealth and is automatically incorporated into the Food Standards Code as maintained by FSANZ. Subsequent amendments to the Code after 2022 may affect these provisions, but the instrument does not address that. The transition period of 36 months means that the final compliance date is 1 June 2025. After that date, the old FSMP rules for weight‑loss products cease to apply to VLED foods, and only the new rules remain in force. The instrument does not contain a sunset or review clause; the new provisions are permanent unless amended later. This variation also amended Standard 2.9.6 to note that provisions of that transitional standard cease to have effect in relation to VLED foods three years after commencement, effectively bringing VLED foods under the permanent regime sooner than other special purpose foods that may still rely on transitional provisions.

The instrument does not reference any litigation, and no cases are cited in the source. At the time of writing, there is no publicly recorded litigation specifically concerning the VLED variations in the Food Standards Code. However, broad enforcement actions under state food laws have occurred for other FSMP labelling breaches in the past. The absence of reported cases does not guarantee that compliance actions have not been taken privately by regulators. The prohibition on health claims and the strict compositional requirements create potential grounds for legal challenge by manufacturers who might argue that the prohibition is ultra vires the parent Act or that it unreasonably restricts trade. Under section 92 of the FSANZ Act, the Board must have regard to certain criteria (including the protection of public health and safety, and the provision of adequate information). A court could be asked to review the validity of the variation if it is alleged that the Board failed to consider economic impacts or that the definition of VLED is impermissibly narrow. No such challenge has been reported to date. Additionally, the instrument’s application in New Zealand may be subject to challenge under the Trans‑Tasman food regulatory framework. Given the technical nature of the compositional requirements (e.g., the PDCAAS calculation method referenced from a 1991 FAO publication), disputes could arise over calculation methods. The litigation history is therefore null at present, but potential future disputes could centre on the meaning of “range of food” in the definition, or on whether a product that provides sole nutrition but does not meet the exact energy range can be marketed as “VLED style” without falling foul of the prohibition.

Several provisions in the variation contain traps for the unwary. First, the definition of “very low energy diet” requires that the food be “specially formulated for the dietary management of overweight and obesity”. If a manufacturer markets a very low energy product primarily for other uses (such as pre‑surgery fasting) it may not meet the definition and could fall outside the VLED category, potentially losing FSMP status altogether. Second, the energy range of 1880‑3345 kJ per day is absolute. A product that provides, say, 1700 kJ per day when consumed according to directions cannot be a VLED, even if it contains all the required nutrients. This may force reformulation. Third, the requirement that the VLED “provide the sole source of nutrition” means that the directions for use must be sufficient for total energy and nutrient needs. If the label suggests consuming the product alongside other foods, it is not a VLED and cannot be sold as one. Fourth, the prohibition on health claims is absolute. A manufacturer cannot make any health claim, including a general “well‑being” claim or a claim about weight loss. Even a claim like “supports energy levels” could be seen as a health claim if it refers to a physiological effect. This may limit marketing options. Fifth, the labelling must state the recommended daily quantity of all VLED foods to be consumed to provide the sole source of nutrition. If the product is one component of a range, the label must be clear about the total quantity of all VLED foods needed. This is a departure from the usual per‑serve declarations. Sixth, the advisory statements about pregnancy, lactation, and age groups are mandatory. Omitting them is a breach even if the product is rarely used by those groups. Seventh, the nutrition information required per serving for VLED foods includes linoleic acid and α‑linolenic acid. Many manufacturers may not have previously analysed for these fatty acids; new testing or formulation adjustments will be needed. Eighth, the PDCAAS requirement is calculated according to a 1991 FAO document. The method may be outdated, but the instrument legally requires its use. Manufacturers using a different protein quality calculation method (e.g., DIAAS) are not compliant. Ninth, the transition period allows sale under either old or new rules, but only for the entire product. A manufacturer cannot mix and match provisions; they must choose one regulatory regime. If they choose the old regime, they must still ensure that the product is not caught by the new exclusion of non‑VLED weight‑loss foods from FSMP. That is, a product that was an FSMP under the old definition but is not a VLED under the new definition cannot be sold as an FSMP after the transition period ends. Tenth, the L‑amino acid rule in subsection 2.9.5‑18(2) overrides the general FSMP permission. Manufacturers who had been adding amino acids for non‑protein reasons (e.g., flavour or marketing) will need to remove them or justify their addition as necessary to improve protein quality. This may affect product taste and production cost.

Businesses that wish to sell a VLED product in Australia or New Zealand must take several steps. First, they should determine whether their product meets the definition: it must be specially formulated for the dietary management of overweight and obesity and must be intended to provide the sole source of nutrition. If the product is a meal replacement that does not claim to be sole source, it is not a VLED and should not be labelled as such. Second, the formulation must be calculated to deliver the required daily intakes when consumed according to the manufacturer’s directions. This means using the energy range and nutrient minima as a daily target. The product should be tested or formulated to ensure that the daily intake (the total amount of all VLED foods used per day) supplies at least 1880 kJ and no more than 3345 kJ. The available carbohydrates must be at least 50 g, and the protein at least 50 g with a PDCAAS of exactly 1 (using the 1991 FAO method). The fatty acid content must meet the linoleic and α‑linolenic minima and the ratio requirement. The full list of vitamins and minerals in table S29‑22 must be present at or above the listed minimum amounts per daily intake. If any nutrient falls short, the product is non‑compliant. Manufacturers must consider whether the L‑amino acid addition rule restricts their current recipe. Third, the label must be redesigned to include the mandatory statements. It must state the recommended daily quantity of all VLED foods to be consumed for sole‑source nutrition. It must include the three advisory statements exactly as set out in paragraphs 2.9.5‑10(1)(h)(i)‑(iii). The nutrition information panel must be reformatted to comply with new subsection 2.9.5‑13(2), which requires the average quantity per serving, average energy per serving, and minimum amounts or average quantities for the specified nutrients, including linoleic acid and α‑linolenic acid. The label must also comply with Division 6 of Standard 1.2.1 (country of origin). Fourth, the product must not bear any health claim. All existing health claims must be removed from the label and any promotional material. This includes implied claims through imagery or endorsements. Fifth, during the transition period (1 June 2022 to 1 June 2025), a manufacturer may choose to comply with either the old Code or the new Code. If the old Code is chosen, the product must still meet the old FSMP definition, which may be problematic because the old definition did not exclude non‑VLED weight‑loss foods. However, after the transition period, only the new Code is permissible. Therefore, manufacturers should use the transition to test, reformulate, and relabel. Sixth, importers should verify that overseas formulations meet the Australian minima, especially for fatty acids and micronutrients, as international products might not be formulated to these levels. Seventh, record‑keeping is essential: manufacturers should retain calculations showing that the daily intake meets the energy range and nutrient minima, as these may be requested by enforcement officers. The PDCAAS calculation method should be documented. Laboratory analyses for linoleic acid, α‑linolenic acid, and each listed vitamin/mineral should be kept. Finally, businesses should monitor any further amendments to the Code that may adjust the table in S29‑22 or the energy range, and should also check state‑specific labelling requirements (e.g., Health Star Rating, country of origin). Compliance is a continuous process; even after labelling is updated, manufacturers must ensure that future batches remain consistent with the compositional requirements.