TGA · AHPRA · FSANZ · ACCC

    Last reviewed: September 2025

    Supplement & VDS Brand Advertising Compliance Australia 2025 — TGA · FSANZ · ACCC

    1. Regulatory framework for supplement advertising

    Supplement and VDS brands in Australia operate under one of the most specific advertising frameworks in any consumer category. The TGA classifies most vitamins, minerals, herbal medicines, and nutritional supplements as Listed Medicines — therapeutic goods that are self-assessed by their sponsors against TGA standards and included on the ARTG with an AUST L number. That classification creates advertising obligations that most supplement marketers significantly underestimate.

    RegulatorWhat they governKey instrumentRisk level
    TGAAdvertising claims for ARTG-listed therapeutic goodsTherapeutic Goods Advertising Code 2021Very High
    ACCC / ACLMisleading or deceptive conduct; false product representationsAustralian Consumer Law, ss.18, 29High
    FSANZHealth claims on food products and food-positioned supplementsStandard 1.2.7, Food Standards CodeMedium–High
    AHPRAWhere a registered health practitioner endorses or promotes a productAHPRA Advertising GuidelinesMedium

    The "I didn't know" defence does not work. All four regulators treat advertiser ignorance as no defence. TGA issued 4,806 removal requests in 2023–24 and 147 infringement notices totalling $2.20M — a significant proportion targeting supplement and VDS brand digital content.

    2. ARTG indications — the ceiling of your claims

    Every Listed Medicine (AUST L) on the ARTG has a set of approved indications — the specific health statements the TGA has accepted as appropriate for that product. These are not suggestions. They are the legal ceiling of what that product can be advertised to do.

    Marketing copy on any channel — product pages, social captions, email subject lines, search ads, influencer briefs — constitutes advertising under the Therapeutic Goods Advertising Code if it promotes a Listed Medicine. All of that copy must stay within the product's ARTG-approved indications.

    What this means in practice:

    • A product with the approved indication "to support immune system health" cannot be advertised as "clinically formulated to protect you from infection" — that implies disease prevention, which exceeds the indication
    • A magnesium product approved for "relief of muscle cramps" cannot be described as "the solution for restless leg syndrome" without a separate approved indication for that condition
    • Ingredient-level claims that exceed the product indication are a breach even if the underlying science supports them — it is the product's approved indication that governs, not ingredient research

    To check a product's approved indications, search the ARTG at artg.tga.gov.au using the product name or AUST L number. Cross-reference every advertising claim against the indications listed there before publication.

    3. Permitted Indications — how the pre-approved claim list works

    The TGA maintains a Permitted Indications Database for Listed Medicines — a publicly available list of pre-approved indication statements that do not require individual TGA assessment. If a claim appears in the Permitted Indications list and is included in the product's ARTG entry, it can be used in advertising.

    How to use the Permitted Indications Database:

    1. Search the database at tga.gov.au for your product's therapeutic area (e.g. "immune", "energy", "digestive")
    2. Find indications that match the product's formulation and evidence base
    3. Cross-reference against what is included in the product's ARTG entry
    4. Use only claim language that mirrors the approved indication — paraphrasing that changes the meaning or scope is a breach

    Claims that are NOT in the Permitted Indications list require either a higher standard of substantiation or are prohibited. A claim that your product "treats", "cures", "prevents", or "eliminates" a condition is virtually never a Permitted Indication for a Listed Medicine — these are restricted representations requiring either Registered Medicine status or Secretary pre-approval.

    4. Mandatory statements in supplement advertising

    The Therapeutic Goods Advertising Code requires specific mandatory statements in consumer-directed advertising for Listed Medicines. These are not optional disclosures — their omission is a breach, and their presence in fine print that consumers are unlikely to read is insufficient.

    Required mandatory statements (ss.14–16 of the Advertising Code):

    • The product's AUST L number (e.g. AUST L 123456)
    • The name of the sponsor (as registered on the ARTG)
    • "Always read the label and follow the directions for use"

    Where mandatory statements must appear:

    • All product pages and product listings on direct-to-consumer sites
    • Paid advertising (Meta, Google, programmatic) — note that character limits in ad formats do not excuse omission; use the landing page if the ad itself cannot accommodate the statement
    • Email promotions that name a specific product
    • Influencer content briefed to include product health claims

    One commonly overlooked obligation: retailer product listings on third-party marketplaces (Amazon, iHerb, Chemist Warehouse online) are advertising for the purposes of the Advertising Code. Supplement brands are responsible for ensuring that product copy on these platforms includes mandatory statements and stays within approved indications — even though the brand does not directly control the platform.

    5. Compliant vs non-compliant examples

    ❌ NON-COMPLIANT

    "Our immune formula is clinically proven to stop colds and flu before they start. Scientifically formulated with zinc and vitamin C to prevent infection."

    ✅ COMPLIANT

    "Formulated with zinc and vitamin C to support immune system health. AUST L 123456. Always read the label and follow the directions for use."

    ❌ NON-COMPLIANT

    "Customers say: 'This product completely cured my joint pain — I haven't needed pain medication since starting it.' ⭐⭐⭐⭐⭐"

    ✅ COMPLIANT

    "Formulated to support joint health and mobility. Always read the label and follow the directions for use. AUST L 123456."

    ❌ NON-COMPLIANT

    "The #1 weight loss supplement — helps you burn fat and drop kilos fast. Clinically tested formula that delivers results."

    ✅ COMPLIANT

    "Formulated to support healthy weight management as part of a balanced diet and exercise program. AUST L 123456. Always read the label and follow the directions for use."

    6. Restricted representations — serious condition claims

    Section 20–21 of the Advertising Code prohibits restricted representations — claims that refer to serious conditions — unless the advertiser has received pre-approval from the Secretary of the Department of Health or can demonstrate a Registered Medicine (AUST R) pathway.

    Conditions that are restricted representations for Listed Medicines:

    • Cancer and malignant conditions
    • Cardiovascular disease and cardiac conditions
    • Mental illness and psychiatric conditions
    • Diabetes and insulin resistance
    • HIV/AIDS
    • Sexually transmitted infections
    • Serious neurological conditions (dementia, Parkinson's, MS)
    • Serious eye and ear conditions

    Supplement brands frequently breach s.20–21 by making indirect claims that imply a therapeutic effect on a serious condition — for example, describing an omega-3 product as "supporting cardiovascular health" where the surrounding context implies treatment or prevention of heart disease rather than general health maintenance. The distinction is assessed by how a reasonable consumer would understand the overall advertising, not by the technical meaning of individual words.

    7. Social media, influencer, and email compliance

    Social media: Every social media post that promotes a Listed Medicine is advertising under the Advertising Code. Instagram captions, TikTok product endorsements, Facebook product posts, and Pinterest pins are all subject to mandatory statement requirements, the prohibition on testimonials, and the indications ceiling. The platform's own approval of an ad does not indicate TGA compliance.

    Influencer content: If an influencer receives free product, payment, or any benefit in exchange for posting about a supplement, that content is advertising for the purposes of the Advertising Code — regardless of whether the influencer discloses the relationship. The brand is responsible for ensuring the influencer's content stays within the product's approved indications. This means:

    • Influencer briefs must specify what claims can and cannot be made
    • Influencer content must be reviewed before posting wherever possible
    • Content that exceeds approved indications is a TGA breach attributed to the brand, not the influencer

    Email marketing: Promotional emails naming specific Listed Medicines must include mandatory statements (AUST L number, sponsor name, always read the label) in the email body — not just on the landing page. Subject lines that make health claims are advertising and subject to the same rules.

    8. Common compliance mistakes

    MISTAKE — Ingredient-level claims that exceed the product's approved indication PROBLEM — "Contains turmeric, which clinical studies show reduces inflammation" attributes a specific therapeutic effect to an ingredient. If the product's approved indication is "to support healthy inflammatory response" rather than "reduces inflammation", the claim exceeds the indication. FIX — Align all ingredient-level claims with the product's approved indication. "Formulated with turmeric to support a healthy inflammatory response" stays within a typical Permitted Indication.

    MISTAKE — Publishing influencer content without reviewing it against ARTG indications PROBLEM — Influencers describe products using language drawn from general internet research rather than the product's approved indications. A food and wellness influencer describing a probiotic as "curing" gut issues is a TGA breach attributed to the brand. FIX — Provide influencers with a one-page claim guide specifying the exact indication language, mandatory statements, and prohibited terms for each product. Review content before it goes live.

    MISTAKE — Missing mandatory statements on retailer product listings PROBLEM — Brands ensure mandatory statements appear on their own website but don't audit third-party retailer listings (iHerb, Amazon, Chemist Warehouse online). The brand is responsible for mandatory statements wherever the product is advertised. FIX — Conduct quarterly audits of all third-party product listings. Provide retailers with compliant product copy that includes mandatory statements.

    9. How CompliGUARD automates this check

    CompliGUARD reviews supplement and VDS brand marketing content — product pages, social captions, email copy, influencer briefs, and retailer listing copy — against TGA · AHPRA · FSANZ · ACCC simultaneously. For ARTG-listed products, CompliGUARD cross-references marketing copy against the product's specific approved indications, flagging claims that exceed the registered scope or omit mandatory statements. Every review produces a clause-cited compliance report, a risk rating, a compliant rewrite, and a timestamped record stored in a tamper-evident audit vault. For brands managing dozens or hundreds of active SKUs, CompliGUARD reviews content at the speed of publication.

    10. Penalty reference

    RegulatorOffence typeIndividual maxCorporate max
    TGAInfringement notice$19,800$19,800
    TGACivil/court penalty$220,000$1.1M
    TGACriminal offence (s.42DL)12 months imprisonment—
    ACCC / ACLMisleading or deceptive conduct$2.5M$50M
    ACLFalse product representations$2.5M$50M

    11. Pre-publish checklist

    TGA — Therapeutic Goods Advertising Code

    Before you publish, check:

    • □All claims match or stay within the product's ARTG-approved indications
    • □No claims exceed the Permitted Indications for this product category
    • □AUST L/R number included in all advertising
    • □Sponsor name included in all advertising
    • □"Always read the label and follow the directions for use" included in all advertising
    • □No testimonials attributing health outcomes to the product
    • □No restricted representations (serious condition claims) without Secretary pre-approval
    • □Retailer product listings reviewed against mandatory statement requirements

    ACCC / ACL

    Before you publish, check:

    • □All efficacy claims are substantiated by evidence
    • □No "clinically proven" claims without specific, applicable evidence
    • □No misleading comparative claims ("better than", "#1")
    • □No misleading outcome claims ("cures", "eliminates", "guarantees")

    FSANZ (for food-positioned products)

    Before you publish, check:

    • □If positioned as a food, health claims comply with Standard 1.2.7
    • □Nutrient content claims use approved formats
    • □No general-level health claims that are not pre-approved by FSANZ

    Influencer content

    Before you publish, check:

    • □Influencer brief specifies permitted and prohibited claim language
    • □Content reviewed against product ARTG indications before posting
    • □Mandatory statements included in or adjacent to influencer content

    12. Key takeaways

    1. All advertising claims for Listed Medicines must match the product's ARTG-approved indications — the Permitted Indications Database defines the ceiling of what can be said.
    2. Mandatory statements (AUST number, sponsor name, always read the label) are required on all consumer-directed advertising including product pages, email, and social posts.
    3. Testimonials attributing health outcomes to a supplement are prohibited under the Therapeutic Goods Advertising Code, s.17.
    4. Influencer content briefed by the brand is the brand's advertising — the brand is responsible for TGA compliance of that content.
    5. Retailer product listings on third-party platforms are advertising — mandatory statements and indication compliance apply there too.

    → Health Food & Functional Beverage Advertising Compliance → Online Pharmacy Advertising Compliance → What free tools do the TGA and AHPRA provide? → What mandatory statements are required on supplement advertising?

    14. Regulatory references

    • Therapeutic Goods Advertising Code 2021 (Cth), s.8 (prohibited representations — general)
    • Therapeutic Goods Advertising Code 2021 (Cth), ss.14–16 (mandatory statement requirements)
    • Therapeutic Goods Advertising Code 2021 (Cth), s.17 (testimonial restrictions)
    • Therapeutic Goods Advertising Code 2021 (Cth), ss.20–21 (restricted representations — serious conditions)
    • Therapeutic Goods Act 1989 (Cth), s.42DL (prohibited advertisements)
    • TGA Permitted Indications for Listed Medicines (current)
    • Australian Consumer Law (Schedule 2, Competition and Consumer Act 2010), ss.18, 29
    • FSANZ Food Standards Code, Standard 1.2.7 (nutrition, health and related claims)

    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.

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