What does TGA s.42DLB prohibit when a cosmetic clinic advertises injectables?
Section 42DLB of the Therapeutic Goods Act 1989 prohibits any consumer-facing advertisement that refers to a Schedule 4 prescription substance — directly, by trade name, or by lookalike euphemism. Cosmetic injectables (botulinum toxin, most dermal fillers regulated as medicines) are Schedule 4. The TGA requested removal of more than 13,700 unlawful advertisements in 2024–25 alone, with civil penalties up to $1.65M per breach for individuals and $16.5M for corporations.
Reviewed 2026-05-03Therapeutic Goods Act 1989, s.42DLB(1) — Civil penalty relating to advertisements.
A person contravenes this subsection if … the person advertises, by any means, therapeutic goods; or … causes the advertising, by any means, of therapeutic goods; and … subsection (2), (3), (4), (5), (6), (7), (8) or (9) applies to the advertisement.
Source: Therapeutic Goods Act 1989 — s.42DLB (federal register)
The substance, in plain English.
Subsection 42DLB(7) is the cosmetic-injectables limb. It bites whenever an advertisement refers to substances, or goods containing substances, in Schedule 3, 4 or 8 of the Poisons Standard. Cosmetic injectables — botulinum toxin and the dermal fillers regulated as medicines — are Schedule 4. Direct trade-name references (Botox, Dysport, Xeomin, Juvederm where regulated as a medicine) sit squarely inside the prohibition.
Lookalike euphemisms have been pulled inside the prohibition. The TGA's updated guidance treats non-specific terms such as "wrinkle reducing injections", "anti-wrinkle injectables" or "the injectable starting with B" as references to the underlying Schedule 4 substance and therefore as captured advertising. The earlier industry workaround of trading the brand name for a euphemism is now itself the breach.
Promoting a health service as a route to a prescription medicine is an indirect breach. A landing page that markets "injectables consultations from $99" while making the underlying substance obvious from context falls inside s.42DLB. The TGA's compliance position is that the substance need not be named — if a reasonable consumer would understand the service as a route to a Schedule 4 medicine, the advertisement is captured.
Section 42AA carves out advertising directed exclusively to health professionals, pharmacists and other named groups. Practitioner-facing trade publications, peer-only education content, and conference materials are outside the s.42DLB prohibition. Public-facing social media is not — even if the post is tagged as "educational".
Consequences sit at multiple levels. The TGA can request removal of unlawful advertisements (it requested 13,700+ removals in 2024–25), issue infringement notices up to $13,320 per contravention for individuals and $66,600 for body corporates, and seek civil penalties up to $1.65 million per breach for individuals and $16.5 million for corporations. Multiple advertisements give multiple contraventions; a year of non-compliant content compounds quickly.
Maximum penalty: Civil penalty up to $1.65 million per breach for individuals and $16.5 million per breach for body corporates. Infringement notices up to $13,320 per contravention for individuals and $66,600 for body corporates. Each non-compliant advertisement is a separate contravention..
Recent enforcement under this provision:
- 2025
TGA — 13,700+ unlawful advertisements removed in 2024–25
The TGA requested removal of more than 13,700 unlawful advertisements from digital platforms in the 2024–25 financial year, addressing the surge in social-media promotion of prescription-only medicines including cosmetic injectables and Ozempic-class GLP-1s.
- 2024
Queensland individual — counterfeit botulinum toxin + advertising
TGA issued two infringement notices totalling $7,716 to a Queensland-based individual for the alleged unlawful importation of counterfeit botulinum toxin type A and the unlawful advertising of cosmetic injectables.
TGA — Infringement notices (compliance actions and outcomes)
- 2024
Two registered nurses — cosmetic injectables advertising
TGA issued infringement notices of $13,656 to two registered nurses for allegedly importing unapproved cosmetic injectables and advertising prescription-only medicines on social media in breach of s.42DLB.
TGA — Infringement notices (compliance actions and outcomes)
A worked example.
A Brisbane cosmetic clinic runs a Meta campaign with the caption "Botox special — $9 per unit, book this week" and a TikTok piece tagged "#antiwrinkleinjections" featuring a creator describing her "baby B" treatment. Both pieces breach s.42DLB(7). The Botox reference is a direct trade-name breach. The "#antiwrinkleinjections" tag and the "baby B" euphemism are captured by the TGA's updated guidance on indirect references. Each ad-set delivery is a separate contravention. At the infringement-notice tier the exposure is $13,320 per contravention for the practitioner and $66,600 per contravention for the corporate entity; civil-penalty escalation reaches $1.65M / $16.5M per breach. The clean version: a service-page that promotes "non-surgical facial treatments — book a consultation" without naming the substance, the brand or any euphemism for it, with all clinical language reserved for the post-consultation, behind-login patient context.
The questions that come next.
Can we say "botulinum toxin" instead of "Botox" on our website?
No. Botulinum toxin is the active ingredient in a Schedule 4 medicine. Naming the substance is the same breach as naming a brand. The TGA's compliance position is that the prohibition captures references to the substance, the brand, and lookalike euphemisms equally.
What about "anti-wrinkle injections" — surely that's generic?
The TGA's updated guidance treats "anti-wrinkle injections", "wrinkle reducing injections" and similar non-specific terms as captured references to the underlying Schedule 4 substance. The pre-2024 industry workaround of trading the brand name for a euphemism is now itself the breach.
Can we discuss the substance with a patient who has already booked?
Yes — practitioner-to-patient communication inside an established clinical relationship is not consumer-facing advertising for the purposes of s.42DLB. The line is the public-facing surface. Consultation notes, post-procedure aftercare emails and behind-login patient portals are outside the prohibition; a public service page or social post that names the substance is inside it.
Is a Google Search ad bidding on the brand name a breach?
Yes. Bidding on a Schedule 4 brand keyword and serving an ad — even if the ad copy avoids the brand — is the kind of indirect promotion the TGA captures. The substance does not need to appear in the ad copy if the keyword targeting and landing page make the substance the obvious subject.
Does the prohibition apply to a closed-group Facebook page or a paywalled email list?
If the closed group or list is a member-of-the-public audience, yes. The s.42AA carve-out is limited to advertising directed exclusively to health professionals and certain other professional groups. "Closed" or "members-only" does not, on its own, take the audience outside the prohibition unless the audience is verifiably a health-professional group.
Read it for yourself.
Brief us with the regulator already in line one.