The Therapeutic Goods Administration (TGA) has issued 10 infringement notices, totalling $198,000, to Midnight Health Pty Ltd (Midnight Health) for the alleged unlawful advertising of prescription-only weight-loss medicines in contravention of the Therapeutic Goods Act 1989 (the Act).
Midnight Health paid the infringement notices in September 2025.
Midnight Health operated telehealth platforms such as Youly, Stagger, and hub.health where it advertised prescription-only weight-loss medicines to the public between June 2024 and January 2025. The websites allegedly promoted the use and supply of Schedule 4 prescription-only medicines, including tirzepatide and semaglutide.
The advertising of prescription-only medicines directly to the public is prohibited under the Act as it can create inappropriate demand and undermine the relationship between patients and their treating medical practitioners.
The advertisements also made unapproved references to the treatment of serious diseases or conditions, such as anxiety and stroke, which are considered prohibited and restricted representations under the Act. Prohibited and restricted representations are not permitted in advertising for therapeutic goods without prior approval or permission from the TGA.
The TGA has also accepted a court enforceable undertaking from Midnight Health, who acknowledges that the websites likely contravened relevant advertising rules.
The undertaking is enforceable for a period of one year and requires Midnight Health to:
- ensure it does not advertise therapeutic goods, including referring to individual prescription-only medicines in a way that breaches the Act
- engage a compliance and legal consultant to advise on relevant therapeutic goods regulatory procedures
- report actions taken to comply with the enforceable undertaking to the TGA.
Breaching any term of the undertaking may result in the Federal Court imposing further orders on the company, including financial penalties or compensation.
Health services that advertise or supply therapeutic goods to the public are responsible for understanding their legal obligations under the Act.
The TGA will continue to take action where serious non-compliance with the Act is identified in accordance with our regulatory compliance framework. This may include issuing infringement notices, directions and prevention notices, or civil or criminal proceedings.
If you suspect non-compliance in relation to therapeutic goods, or their advertising, you can report it to the TGA at any time.
