TGA fines Midnight Health over unlawful prescription medicine ads

The Therapeutic Goods Administration has issued ten infringement notices, totalling $198,000, to Midnight Health Pty Ltd for alleged breaches of the Therapeutic Goods Act 1989 relating to the advertising of prescription-only weight management medicines.

Midnight Health operates a number of telehealth platforms, including Youly, Stagger, and hub.health. Between June 2024 and January 2025, these sites are alleged to have promoted prescription-only medicines, including tirzepatide and semaglutide, directly to the public.

Under the Act, advertising prescription-only medicines to consumers is prohibited as it can encourage inappropriate demand and interfere with the clinical relationship between patients and their treating health professionals.

The advertising also allegedly included references to serious conditions such as anxiety and stroke. These are classified as “prohibited” and “restricted” representations under the Act and cannot be used in therapeutic goods advertising without prior TGA approval or permission.

In addition to the infringement notices, the TGA has accepted a court-enforceable undertaking from Midnight Health. The undertaking, which will remain in place for one year, requires the company to:

• stop advertising therapeutic goods in ways that breach the Act, including naming prescription-only medicines

• engage a compliance and legal adviser to review its regulatory procedures

• provide the TGA with reports on its actions to meet the terms of the undertaking.

If the company breaches the undertaking, the Federal Court may impose further orders, including financial penalties or compensation.

The TGA has reiterated that businesses advertising or supplying therapeutic goods to the public are responsible for understanding their obligations under the Act. It also confirmed it will continue to take enforcement action where serious non-compliance is identified.