TGA · AHPRA · FSANZ · ACCC

Last reviewed: September 2025

Health Food & Functional Beverage Advertising Compliance Australia 2025 — FSANZ · TGA · ACCC

1. The regulatory framework: FSANZ vs TGA — which one applies?

The fundamental compliance question for any health food or functional beverage brand is whether the product is classified as a food or a therapeutic good. The classification determines the primary regulatory framework, the permitted claims, and the enforcement agency.

The product is a food (FSANZ governs): A product is a food if it is sold and represented as a food — it is intended for consumption, it is positioned in the category and channel appropriate to food, and its claims fall within the scope of FSANZ Standard 1.2.7. Health claims on food are permitted, subject to Standard 1.2.7's pre-approved claim lists and conditions.

The product is a therapeutic good (TGA governs): A product is a therapeutic good if it is presented as having a therapeutic purpose — preventing, diagnosing, treating, curing, or alleviating disease or illness. Once a product is captured by the therapeutic goods definition, TGA rules apply: ARTG registration (AUST L or AUST R), the Therapeutic Goods Advertising Code, mandatory statements, and prohibition on claims that exceed approved indications.

The same product can be both: A product that is inherently a food but makes therapeutic claims becomes a therapeutic good for the purposes of those claims. This is the food-medicine interface problem: a protein powder sold as a food that claims to "support recovery from injury" has made a therapeutic claim that subjects it to TGA advertising requirements for that claim — even though the underlying product remains food-classified.

2. The food-medicine interface — the FMIGT determination

The TGA administers the Food-Medicine Interface Guidance Tool (FMIGT) to help brands determine whether a specific product, with its specific intended purpose and claims, sits on the food side or the therapeutic goods side of the interface. Using the FMIGT before publishing claims is one of the most important compliance steps a health food brand can take.

How the FMIGT works: The FMIGT requires consideration of the product's: physical form, concentration of active ingredients, recommended dosage, marketing representation, and intended purpose as a whole. The outcome is a determination of whether the product, as marketed, would be classified as a therapeutic good or a food. The FMIGT determination is not legally binding — it is guidance — but it is evidence of due diligence and represents the TGA's position on how equivalent products have been treated.

Products most at risk of interface issues:

• Protein powders and amino acid supplements marketed for muscle recovery, injury support, or sports performance
• Greens powders and superfood blends marketed for "detox", "immunity", or "cellular energy"
• Herbal teas and botanical beverages marketed for relaxation, sleep, or stress relief
• Collagen drinks marketed for joint health, gut health, or skin repair
• Kombucha, kefir, and probiotic beverages marketed for immune or gut health
• Energy drinks marketed with functional claims beyond caffeine

The interface trigger: therapeutic language The claim that triggers interface scrutiny is one that attributes a specific physiological or therapeutic mechanism to the product. "Contains antioxidants" is a nutrient content claim that can remain in food territory. "Antioxidants that combat cellular damage" attributes a mechanism — this is likely therapeutic language that moves the product toward TGA classification.

3. FSANZ Standard 1.2.7 — health claims permitted on food

FSANZ Standard 1.2.7 establishes a nationally consistent framework for health claims on food products and in food advertising in Australia and New Zealand. It creates three distinct claim categories, each with different pre-approval requirements.

Nutrition content claims Statements about the presence, absence, or quantity of nutrients in the food. Permitted where the food meets the relevant criteria in the Standard (e.g. "high fibre", "low sodium", "source of calcium"). These are not health claims under the Standard but are subject to the criteria in Schedule 1.

General level health claims Claims that link a food or food component to general health or health-related function, without referencing a serious health condition. For example: "Calcium supports bone health." These are permitted for specific relationships listed in Standard 1.2.7 Schedule 4, provided the food meets the nutrient profiling score (NPS) — a scoring system that prevents health claims on foods that are nutritionally poor overall.

High level health claims Claims that link a food or food component to a serious health condition (disease, disorder, or condition). For example: "Diets rich in omega-3 fatty acids may reduce the risk of heart disease." These require pre-approval and must use only relationships listed in Schedule 5. The claim must be worded as indicated in the Schedule — paraphrase that changes the scope or meaning of the approved relationship is not permitted.

4. General-level vs high-level health claims

The practical distinction between general-level and high-level claims is critical for health food marketing — getting it wrong in either direction is a breach.

General level examples that are permitted (Schedule 4):

High level examples that require Schedule 5 pre-approval:

The grey zone — claims that are likely high-level but commonly published as general:

• "Supports immune function" — general-level claim in some contexts; high-level where it implies protection from or reduced risk of infection
• "Promotes gut health" — general-level if referring to digestive function; moves toward high-level if implying disease risk reduction for conditions like IBS or Crohn's
• "Supports cognitive performance" — general-level claim; high-level if implying risk reduction for neurological conditions

The NPS requirement cuts across both levels: a food that fails the nutrient profiling score cannot carry health claims at all, regardless of whether the claim itself is pre-approved. A high-sugar, high-sodium functional food cannot legally carry a health claim even if the specific nutrient it claims to deliver is genuine.

5. Nutrient content claims — permitted and prohibited

Nutrient content claims describe a specific nutrient's presence or quantity without linking it to a health outcome. They are subject to Standard 1.2.7 conditions (Schedule 1) but are simpler to navigate than health claims.

Permitted nutrient content claims (examples):

• "High fibre" — requires ≥4g fibre per serve for solid food
• "Low sodium" — requires ≤120mg sodium per 100g
• "Source of vitamin C" — requires ≥10% of the recommended daily intake
• "Reduced fat" — requires at least 25% less fat than the reference food

Prohibited or misleading nutrient content claims:

• "Rich in probiotics" — probiotics are not recognised as a measurable nutrient under Standard 1.2.7 in the way vitamins and minerals are; a claim about probiotic count requires care about implied therapeutic benefit
• "High in antioxidants" — antioxidants are not a regulated nutrient with a defined claim criterion; this phrase cannot be used as a nutrient content claim under Standard 1.2.7
• "Contains collagen" — collagen is not a nutrient with a defined permitted claim; presence alone is a composition statement, but attributing health benefits to it (for skin, joints, gut) typically crosses into therapeutic or health claim territory
• "Gut-healing ingredients" — "healing" is therapeutic language; even if the ingredients are food ingredients, the claim moves the product toward TGA classification

6. When a health food brand crosses into TGA territory

The TGA's classification of a product as a therapeutic good is not determined by what the product IS — it is determined by how it is MARKETED. A protein powder marketed as a food with FSANZ-compliant nutrient content claims is a food. The same protein powder marketed with claims about "healing leaky gut", "treating inflammation", or "supporting recovery from autoimmune conditions" is a therapeutic good — and the marketing alone has created that classification.

Claims that trigger TGA classification:

• References to specific diseases, disorders, or conditions by name
• Claims about treating, preventing, or alleviating illness
• References to therapeutic mechanisms ("anti-inflammatory", "immunomodulatory", "adaptogenic" in a specific context)
• Claims about specific physiological effects that are medical in nature ("regulates cortisol", "balances hormones")

What happens when TGA classification applies: Once a product's marketing has triggered TGA classification, the full suite of TGA obligations applies: ARTG registration (the product must have an AUST L or AUST R number), the Therapeutic Goods Advertising Code (mandatory statements, indication-matching), and potential criminal liability for continuing to market without registration.

The practical issue for functional food brands: A brand may have a product with genuine FSANZ-compliant health claims that it has been marketing for years. If the brand then creates social content, a blog post, or an influencer campaign that uses therapeutic language about the same product, it has — through that marketing — triggered TGA obligations for that product without realising it.

7. Compliant vs non-compliant examples

8. ACL obligations — "natural", "superfood", and efficacy claims

ACL s.18 (misleading or deceptive conduct) and s.29 (false representations about goods) apply to all health food and functional beverage advertising independently of FSANZ and TGA classification. Several specific claim types in this sector attract ACCC scrutiny.

"Natural" claims: A product claiming to be "natural" creates a reasonable consumer expectation that it does not contain artificial ingredients, flavours, colours, or preservatives. Where a product carries the "natural" label but contains highly refined ingredients, artificial flavours, or synthetic additives, the claim may be misleading under ACL s.29. The ACCC has taken action against "natural" claims in the food and beverage sector in both Australia and comparable markets.

"Superfood" claims: "Superfood" has no legal definition in Australia — it is an unregulated marketing term. Using it is not automatically a breach, but where it creates a specific misleading impression (e.g. that a product has clinically proven health benefits it cannot demonstrate), it may be an ACL breach. The risk is increased where "superfood" is used alongside specific efficacy claims that imply a standard of evidence that does not exist.

"Clinically proven" and "scientifically formulated": These phrases imply a standard of clinical evidence — controlled trials, peer-reviewed research — that most health food brands cannot demonstrate for their specific product. "Clinically proven" for a functional beverage requires clinical evidence specific to that product formula. General scientific literature about an ingredient does not substantiate a "clinically proven" claim for the finished product. Where this evidence does not exist, the claim is a misleading representation under ACL s.29.

Sports nutrition: Sports nutrition products marketed to consumers and athletes face additional ACCC scrutiny for efficacy claims. A protein powder claiming to "build 30% more muscle than standard protein" requires head-to-head comparative clinical evidence for that specific product.

9. Common compliance mistakes

MISTAKE — Publishing therapeutic claims on food-positioned products without checking the FMIGT PROBLEM — A greens powder marketed on Instagram as "fighting inflammation and healing your gut" has made therapeutic claims. The product may be ARTG-unregistered. Marketing an unregistered therapeutic good is a Therapeutic Goods Act breach regardless of how the product is classified in the supply chain. FIX — Run every claim through the FMIGT before publishing. Where claims use therapeutic language, either change the language to FSANZ-compliant food claim territory or register the product with the TGA as a Listed Medicine.

MISTAKE — Using unapproved health claim language on food products PROBLEM — A functional snack bar with the claim "maintains healthy blood pressure" uses a relationship that, while intuitive, is not in Standard 1.2.7 Schedule 4 or Schedule 5 for a general snack bar. Even if the bar contains potassium, the approved claim relationship requires specific wording and nutrient criteria that must be verified before use. FIX — Cross-reference every health claim against Standard 1.2.7 Schedules 4 and 5. Use only the approved claim language and verify the food meets the associated nutrient criteria. The FSANZ website maintains a searchable version of both schedules.

MISTAKE — Publishing "clinically proven" claims based on ingredient research rather than product-specific trials PROBLEM — "Clinically proven omega-3 formula for heart health" on a functional beverage implies clinical evidence for the specific product. Research establishing omega-3's general cardiovascular benefits does not substantiate a "clinically proven" claim for a specific beverage formula at the specific dose it delivers per serve. FIX — Remove "clinically proven" from all product advertising unless product-specific clinical evidence exists. Use "contains [nutrient], which [FSANZ-approved relationship]" — for example, "contains omega-3 fatty acids, which contribute to heart health" where the relevant Schedule 4 relationship applies and the food meets NPS criteria.

10. How CompliGUARD automates this check

CompliGUARD reviews health food and functional beverage marketing content — product pages, social content, email campaigns, influencer briefs, and packaging copy — against FSANZ · TGA · ACCC simultaneously. For food-positioned products, CompliGUARD checks health claims against Standard 1.2.7 Schedule 4 and 5 relationships and the NPS requirement. For claims that approach the food-medicine interface, CompliGUARD applies FMIGT classification logic to identify therapeutic language that may trigger TGA obligations. For TGA-registered products, copy is cross-referenced against the product's ARTG-approved indications. Every review returns a clause-cited compliance report, a risk rating, and a compliant rewrite.

11. Penalty reference

12. Pre-publish checklist

Food-medicine interface check

FSANZ Standard 1.2.7 — Health claims

TGA — Where product is a Listed Medicine

ACCC / ACL

13. Key takeaways

1. The classification of a health food or functional beverage as a food or therapeutic good is determined by how it is marketed — not just what it is. Therapeutic claims on food products trigger TGA obligations including ARTG registration and the Advertising Code.
2. FSANZ Standard 1.2.7 permits health claims on food only for specific pre-approved food-health relationships in Schedules 4 and 5. Claims not on these lists are either not permitted or require pre-approval.
3. The TGA Food-Medicine Interface Guidance Tool (FMIGT) is the correct first step before publishing any health claim that references specific physiological effects, conditions, or mechanisms.
4. "Clinically proven" on a functional food product requires clinical evidence for that specific product — not general ingredient research. This phrase should be avoided in consumer advertising unless that evidence exists.
5. Nutrient content claims ("high fibre", "low sodium") are subject to Standard 1.2.7 Schedule 1 criteria — the food must meet the prescribed threshold before the claim can be made.

14. Related guides

→ Supplement & VDS Brand Advertising Compliance → Online Pharmacy Advertising Compliance → What is the food-medicine interface and how does it affect advertising? → What does FSANZ Standard 1.2.7 allow on food product labels?

15. Regulatory references

• FSANZ Food Standards Code, Standard 1.2.7 (nutrition, health and related claims) — Schedules 1, 4, 5
• Therapeutic Goods Act 1989 (Cth), s.42DL (prohibited advertisements — scheduled medicines)
• Therapeutic Goods Advertising Code 2021 (Cth), ss.8, 14–16, 17, 20–21
• TGA Food-Medicine Interface Guidance Tool (FMIGT) — current version
• Australian Consumer Law (Schedule 2, Competition and Consumer Act 2010), ss.18, 29
• ACCC Advertising and Selling Guide 2021

CompliGUARD provides compliance insights based on TGA, FSANZ, ACCC and AHPRA guidance as current at the time of review. The Therapeutic Goods Advertising Code is currently under formal review by the TGA (2025–26). This output does not constitute legal advice.