Regimen
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19 September 2025· by Bader Eddeen

Midnight Health pays $198,000 across ten infringement notices for advertising semaglutide and tirzepatide

The TGA hit Midnight Health Pty Ltd — operator of telehealth brands Youly, Stagger and hub.health — with ten infringement notices in September 2025 for advertising weight-loss prescription medicines to consumers between June 2024 and January 2025. The company also signed a one-year enforceable undertaking to comply with the advertising rules. It's the largest single-operator action under s.42DLB the TGA has published, and it confirms the regulator's 2026–27 priority focus on weight-loss and erectile-dysfunction medicines is operational, not aspirational.

  • TGA
  • Telehealth
  • Cosmetic

Midnight Health operates a portfolio of DTC telehealth brands aimed at men's health, women's health and weight management. Across the period the TGA reviewed, those brands ran consumer-facing advertising that named or directly referenced the active ingredients of Schedule 4 prescription products — semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro). Section 42DLB of the Therapeutic Goods Act 1989 prohibits any advertisement of a Schedule 4 substance to the public, by any means.

The infringement notices total $198,000, paid by the corporate entity. The enforceable undertaking adds a 12-month compliance regime — the operator must maintain processes, training and review steps that prevent repeat breaches, and report to the TGA on compliance steps taken.

The pattern that drew the action is the one most DTC telehealth platforms still run: condition-led headlines that pair with substance-named or substance-implied creative, often layered into retargeting flows seeded from category-page visitors. The platforms read this as one continuous funnel; the TGA reads each surface as a separate advertisement. Each non-compliant ad is, structurally, a separate breach.

What changed this round is the enforcement signal. The TGA published the action on its public media releases page, named the operator and the brands, and slotted weight-loss medications onto the 12-area priority focus list for 2026–27. Two months earlier, the regulator had already fined four telehealth businesses and three individuals $319,260 across 21 notices for similar advertising. In January 2026 Prime Medic Group paid a smaller $19,800 + $3,960 for the same shape of breach. Three operators in eight months. The category is under sustained surveillance.

The platforms are not the cause; the TGA is the regulator. But the platforms are also not a defence. Meta and Google approved most of the creative this enforcement caught — platform approval is a separate, weaker check. An ad that runs without rejection can still draw a six-figure infringement notice from the TGA the same day.


The take
If your DTC telehealth funnel names the molecule anywhere a consumer can see it — landing page, retargeting, email, podcast pre-roll — assume the TGA has it on a queue. Move to consultation-led marketing this quarter. The operators paying six-figure fines were running creative their agencies and platforms had both signed off.

Sources

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