What does TGA s.42DLB require of an Australian telehealth or DTC health platform's marketing?
Section 42DLB of the Therapeutic Goods Act 1989 prohibits advertising any therapeutic good containing a Schedule 4 (prescription-only) or Schedule 8 substance to the public. For a telehealth or DTC platform, that means the medicine cannot be named, pictured, or pointed at through a condition-led claim — direct or indirect references both engage the section. The TGA requested removal of more than 13,700 unlawful advertisements in 2024–25 and the category is on the priority focus list for 2026–27.
Reviewed 2026-05-03Therapeutic Goods Act 1989 (Cth), s.42DLB.
A person must not, by any means, advertise … a therapeutic good … that contains, or consists of, a substance that is included in Schedule 4 or 8 to the current Poisons Standard … unless the advertisement is directed exclusively to persons who are health practitioners …
The substance, in plain English.
Section 42DLB binds the entity that places, authorises or causes the advertisement. For a telehealth platform that means the operating company, the prescriber featured in the creative and the agency or affiliate placing the media can each be liable. The notice arrives at the platform's registered office regardless of whether the agency drafted the copy. The Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 sits beneath the Act and governs mandatory statements, prohibited representations, testimonials, endorsements and undue alarm; the TGA's social media advertising guidance applies the Code to Meta, TikTok, YouTube and creator content.
Direct references are the easy half — naming Ozempic, Saxenda, semaglutide, tirzepatide, Wegovy, Mounjaro, finasteride, sildenafil or any other Schedule 4 substance in consumer-facing creative is a breach on the first impression. The harder half is indirect references. A landing page that names a condition ("medical weight loss", "erectile dysfunction", "hair loss treatment"), points the user at a specific molecule by visual cue (the pen, the blister, a side-by-side body comparison) or implies the medicine via dose schedule and outcome claim is captured by the same section.
The bright line for the category is substance-side versus consultation-led. Marketing the consultation, the prescriber, the clinical pathway and the conditions the platform treats — without naming the medicine and without indirect references that point to it — is permitted. Marketing the medicine, in any form a reasonable consumer would identify it, is not. Brand-name platforms that operate condition-forward funnels ("speak to a doctor about weight management") sit on the durable side; platforms that run substance-named retargeting from a US playbook do not.
Penalty exposure is significant. The maximum civil penalty is 5,000 penalty units for an individual and 50,000 penalty units for a body corporate. At the current penalty-unit value of $330 (since 7 November 2024), that is $1,650,000 and $16,500,000 per breach respectively. Each non-compliant advertisement is a separate matter. Infringement notices issued in lieu of prosecution are routinely $13,320 per individual contravention and $66,600 per corporate contravention.
From 1 January 2026 weight-loss medications and erectile-dysfunction medications are both on the TGA's 12-area priority focus list for 2026–27. The category is under active surveillance. Compliance posture is set in the spec, not retrofitted to creative — once a platform finds the consultation-led side of the line, the same creative system carries through audits, code clarifications and platform reviews without redraw.
Maximum penalty: 5,000 penalty units for an individual ($1,650,000 at the current $330 unit value); 50,000 penalty units for a body corporate ($16,500,000). Each non-compliant advertisement is a separate breach. Criminal counterpart in s.42DL..
Recent enforcement under this provision:
- 2025
Midnight Health Pty Ltd (Youly, Stagger, hub.health)
Paid $198,000 across 10 infringement notices in September 2025 for advertising semaglutide and tirzepatide on its DTC telehealth brands between June 2024 and January 2025, and gave the TGA a one-year enforceable undertaking to comply with the advertising rules.
TGA — Midnight Health Pty Ltd issued infringement notices for unlawful advertising
- 2024
TGA July 2024 telehealth sweep — four businesses, three individuals
Combined $319,260 across 21 infringement notices issued to four telehealth businesses and three individuals for alleged unlawful advertising of weight-loss and erectile-dysfunction medicines including Ozempic, Saxenda and Viagra.
TGA — Telehealth businesses fined over $300,000 for alleged unlawful advertising
- 2026
Prime Medic Group Pty Ltd
Paid $19,800 (Prime Medic Group) and $3,960 (associated individual) in January 2026 for alleged unlawful advertising of Ozempic and Mounjaro on its online telehealth consultation platform.
- 2025
TGA digital takedown programme 2024–25
TGA requested removal of more than 13,700 unlawful advertisements from digital platforms in 2024–25, with cosmetic injectables and weight-loss medicines the dominant categories. Weight-loss and erectile-dysfunction medications both placed on the 2026–27 priority focus list.
A worked example.
An Australian men's health platform runs a Meta carousel headlined "Lose weight with semaglutide — first month $99", with frame two showing a stylised injection pen and frame three a before/after silhouette. The retargeting funnel then drops users on a landing page titled "Ozempic via telehealth" with a quiz CTA. Three separate s.42DLB breaches before the consult is booked: the substance is named in the headline, indirectly referenced through the pen visual, and named again on the landing page. The TGA social-media surveillance picks the carousel up, the platform receives infringement notices at the corporate maximum, and the public media release names the brand. The compliant rebuild keeps the funnel — same audience, same offer, same payback — but reframes around the condition and the consultation: "Medical weight management with an Australian-registered doctor", clinical pathway shown, no medicine named, no medicine pictured. Same conversion, durable.
The questions that come next.
Can we name the medicine if the page sits behind a login or post-consult?
Behind authenticated, post-consult patient surfaces, naming the prescribed medicine to the patient who has been prescribed it is not advertising for s.42DLB purposes — it is patient communication. The breach line is the public-facing surface: the pre-consult landing page, the paid creative, the SEO page, the affiliate post, the influencer caption. If a non-patient can reach the substance reference without being prescribed, it is in scope.
What about generic category names — "GLP-1", "compounded weight-loss medicine"?
The TGA treats indirect references that a reasonable consumer would resolve to a Schedule 4 substance as captured by s.42DLB. "GLP-1" in a weight-loss context is widely understood to refer to semaglutide or tirzepatide and the TGA has issued notices on that basis. The safer pattern is naming the condition and the consultation, not the molecule class.
Can a prescriber post about the medicine on their personal social account?
Section 42DLB applies to advertising directed at the public. A prescriber's public post that names a Schedule 4 substance and points patients to a platform engages both s.42DLB (substance reference) and AHPRA s.133 (testimonial / advertising rules for the practitioner). Health-practitioner-only forums and closed peer education are different. Public posts are advertising regardless of who drafts them.
Does platform approval (Meta, Google) mean we are clear on s.42DLB?
No. Meta's Health and Wellness ad standard and Google's restricted-vertical review for telehealth are separate, weaker checks against platform policy. An ad that runs without platform rejection can still breach s.42DLB and lead to TGA infringement notices and an enforceable undertaking. The platform never signs the TGA notice.
What is the response window once the TGA contacts us?
The TGA generally requests removal of the specific advertisement first and may seek voluntary undertakings before escalating to infringement notices or civil-penalty proceedings. Same-day removal of the flagged creative and a documented compliance review of the wider campaign is the cleanest position. Repeat or systemic breaches escalate to formal action and a public media release naming the entity.
Read it for yourself.
Brief us with the regulator already in line one.