TGA · AHPRA · FSANZ · ACCC

    TGA and AHPRA enforcement in Australia: what the data tells health marketers (2024–25)

    2 May 2026 · 7 min read
    Summary

    CompliGUARD tracks TGA and AHPRA enforcement so Australian health marketers can see where the risk sits. In 2023–24, the TGA received 3,370 advertising reports, issued 168 warning letters, sent 4,806 removal requests, and issued 147 infringement notices totalling $2.20 million. In 2024–25, AHPRA assessed 775 advertising complaints — a 104% increase over two years. These numbers reflect a compliance environment that has shifted from reactive to proactive: both regulators now use automated monitoring tools to scan digital content, and both are increasing the volume and speed of enforcement action. For health brands and registered practitioners, the question is no longer whether enforcement is likely — it is whether your content will withstand review when it occurs.

    Regulatory enforcement in Australian health marketing used to feel distant. A notice from the TGA or AHPRA was something that happened to large companies after sustained non-compliance — not to supplement brands or individual practitioners posting on Instagram. That perception no longer reflects reality.

    Both the TGA and AHPRA have materially increased their enforcement capability and activity over the past three years. The TGA has published multi-year compliance education strategies, deployed digital monitoring tools, and increased infringement notice activity. AHPRA has seen advertising complaint volumes more than double, introduced a dedicated advertising compliance team, and confirmed that it uses automated scanning to monitor practitioner digital content. The volume of enforcement action in the 2023–24 and 2024–25 reporting periods is not an anomaly — it is the new baseline.

    1. TGA enforcement 2023–24: the numbers

    The TGA Performance Report 2023–24 provides the most comprehensive publicly available data on TGA advertising enforcement activity.

    Reports received: 3,370 advertising reports were received by the TGA in 2023–24. These come from members of the public, competitors, healthcare professionals, and the TGA's own monitoring systems.

    Removal requests: 4,806 removal requests were issued, requiring businesses to take down or amend non-compliant advertising content. A removal request is the TGA's preferred first response — it gives businesses the opportunity to rectify the issue without incurring a financial penalty.

    Warning letters: 168 warning letters were issued to businesses where removal requests were not actioned, where the breach was more serious, or where the business had a prior compliance history.

    Infringement notices: 147 infringement notices were issued, totalling $2.20 million. An infringement notice is a financial penalty that does not require a court proceeding — it is issued directly by the TGA and is payable within 28 days. The penalty per notice for an individual is $10,350. For a body corporate, $51,750.

    The enforcement cascade matters. Most businesses that receive infringement notices have already received a removal request or warning letter for the same or similar content. The TGA's enforcement approach is to escalate when businesses do not respond to earlier action. A removal request that is ignored becomes a warning letter. A warning letter that is ignored becomes an infringement notice. A pattern of infringement notices can lead to prosecution.

    What is triggering TGA action: Based on TGA compliance education materials and enforcement patterns, the most common triggers are: health claims that exceed permitted indications for Listed Medicines; testimonials that imply cure, treatment, or prevention of disease; advertising for unregistered therapeutic goods; missing mandatory statements (AUST number, sponsor name, "always read the label"); and restricted representations (claims touching Schedule 3 conditions) made without prior approval.

    2. AHPRA enforcement 2024–25: the numbers

    AHPRA's advertising compliance data for 2024–25 reflects the steepest increase in complaint volumes on record.

    Complaints assessed: 775 advertising complaints were assessed by AHPRA in 2024–25 — an increase of 104% over two years. AHPRA receives complaints from patients, members of the public, other practitioners, and generates compliance referrals through its own monitoring activities.

    Penalties: Penalties for advertising breaches under s.133 reach $60,000 for an individual and $120,000 for a body corporate, per offence. Each non-compliant advertisement can constitute a separate offence.

    What is triggering AHPRA action: The most common complaint triggers for AHPRA are: patient testimonials on websites and social media; before-and-after images implying a specific treatment outcome; claims of superiority over other practitioners or treatment modalities; unsubstantiated claims about treatment efficacy; and promotional discounts framed as inducements to seek unnecessary treatment.

    AHPRA has confirmed it uses automated tools to scan practitioner websites and social media. A 2019 campaign post that is still live in 2026 is visible to these tools and subject to complaint today.

    3. What the enforcement patterns mean for your marketing programme

    Two conclusions follow from this data that are directly relevant to how health brands and practitioners should approach their marketing compliance.

    First: pre-publication review has become the minimum standard. With enforcement volumes at these levels and automated monitoring in place, the question is not whether your content will be seen by a regulator — it is whether it will pass review when it is. A marketing programme without a pre-publication compliance check is operating without a seatbelt in a jurisdiction where enforcement frequency is increasing year on year.

    Second: the audit trail is your first line of defence. When AHPRA or the TGA contacts a business or practitioner about advertising content, the initial response sets the tone for everything that follows. A brand that can produce a timestamped record showing the content was reviewed against the relevant frameworks before publication is in a materially different position to one that cannot. The record does not guarantee a favourable outcome — but its absence is consistently cited as an aggravating factor in enforcement decisions.

    4. The cost comparison: compliance infrastructure vs. enforcement action

    A single TGA infringement notice costs $10,350 for an individual or $51,750 for a body corporate. A series of notices — which AHPRA and TGA issue where non-compliance is systematic — can total hundreds of thousands of dollars before any legal costs are added.

    CompliGUARD's Practitioner tier begins at $59 per month. Professional Brand tier begins at $599 per month. The cost of a full year of compliance infrastructure across either tier is less than the cost of a single infringement notice. This is not a marketing claim — it is arithmetic.

    How CompliGUARD operates as the always-on compliance layer

    CompliGUARD reviews marketing content against TGA · AHPRA · FSANZ · ACCC frameworks before publication, generates a risk rating for each piece of content, identifies the specific clause engaged, suggests compliant rewrites, and stores a timestamped audit record in the CompliGUARD Audit Vault for five years. For practitioners and brands with ongoing content programmes, CompliGUARD operates as the compliance check that runs between content creation and publication — reducing exposure at the point where it can still be managed.

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    Key takeaways

    1. The TGA issued 147 infringement notices totalling $2.20 million in 2023–24, with 4,806 removal requests sent to businesses advertising non-compliant therapeutic goods.
    2. AHPRA assessed 775 advertising complaints in 2024–25 — a 104% increase over two years.
    3. Both regulators use automated monitoring tools; content published years ago remains subject to current enforcement action.
    4. The most common triggers are: claims exceeding permitted indications, patient testimonials, missing mandatory statements, and unsubstantiated superiority claims.
    5. A documented pre-publication compliance review is the most defensible evidence of reasonable steps if enforcement action is initiated.

    Regulatory references

    • TGA Performance Report 2023–24
    • Health Practitioner Regulation National Law, s.133
    • Therapeutic Goods Act 1989 (Cth), Part 5-1 (advertising offences)
    • AHPRA Advertising Compliance and Enforcement Policy
    • AHPRA Annual Report 2024–25
    • Therapeutic Goods Advertising Code 2021

    Statistics cited in this article are drawn from publicly available TGA and AHPRA annual reports. All figures should be verified against current reports before use in external communications. This content does not constitute legal advice.

    5. Compliant vs non-compliant examples

    ❌ NON-COMPLIANT

    “This product treats the condition and guarantees results.”

    ✅ COMPLIANT

    “This product may support the approved health outcome when used as directed.”

    ❌ NON-COMPLIANT

    “Clinically proven to work for everyone.”

    ✅ COMPLIANT

    “Evidence supports the approved indication; individual outcomes can vary.”

    ❌ NON-COMPLIANT

    “The best treatment available in Australia.”

    ✅ COMPLIANT

    “A treatment option that may be considered after an individual consultation.”

    6. Common compliance mistakes

    • Publishing without checking the complete advertisement’s overall impression.
    • Treating one regulator’s checklist as coverage for every applicable framework.
    • Failing to retain evidence showing what was reviewed and approved before publication.

    7. How CompliGUARD automates this check

    CompliGUARD reviews the complete advertisement against TGA · AHPRA · FSANZ · ACCC requirements, identifies clause-level risks, proposes compliant wording, and retains the result in an audit trail before publication.

    8. Penalty reference

    RegulatorOffence typeIndividual maxCorporate max
    TGATherapeutic goods advertising breachCurrent Act penalty appliesCurrent Act penalty applies
    AHPRANational Law advertising breachCurrent National Law maximumCurrent National Law maximum
    ACCCMisleading or deceptive conductUp to $2.5 millionGreater of $50 million, 3× benefit, or 30% turnover
    FSANZFood Standards Code breachState or territory law appliesState or territory law applies

    9. Pre-publish checklist

    Before you publish, check:

    TGA

    • □Product classification and ARTG indications checked
    • □Mandatory statements and restricted representations checked

    AHPRA

    • □Testimonials, qualifications, incentives and imagery checked

    FSANZ

    • □Nutrition content and health claims checked against Standard 1.2.7

    ACCC

    • □Overall impression, substantiation, pricing and disclosures checked

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