The Therapeutic Goods Administration (TGA) has issued 10 infringement notices totalling $71,280 to Gezond Pty Ltd and 3 registered pharmacists, for the alleged unlawful importation of unapproved melatonin products in contravention of the Therapeutic Goods Act 1989 (the Act).
The Queensland-based company was issued with 2 infringement notices totalling $39,600. Three pharmacists, from Victoria and New South Wales, were issued with 8 infringement notices totalling $31,680. All 3 are registered with the Australian Health Practitioner Regulation Agency.
The infringement notices were paid in July and August 2026.
Under the Act, therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully imported and supplied, unless an approval or exemption applies. The imported products were not in the ARTG and had no exemptions or approvals that permitted their importation into Australia.
Therapeutic goods which have not been entered in the ARTG have not been assessed by the TGA for quality, safety and efficacy and may pose a health risk. The TGA has previously warned consumers about imported melatonin products containing different amounts of melatonin than that stated on the labelling.
Professor Anthony Lawler, Deputy Secretary of the Department of Health, Disability and Ageing and head of the TGA, said these actions undermine public confidence in health professionals and the regulatory system.
"Attempting to supply unapproved therapeutic goods to the public is unacceptable. The unlawful import and supply of such products may put public health at risk.
"The TGA will continue to take strong compliance and enforcement action where businesses and individuals do not meet their legal obligations," Professor Lawler said.
Individuals, health practitioners and businesses must understand their legal obligations under the Act before importing therapeutic goods. Consequences of non-compliance may include infringement notices, direction or prevention notices, or civil or criminal proceedings.
This action reflects the TGA's ongoing compliance and enforcement activities for therapeutic goods and medical devices, as outlined in the TGA's Compliance Principles 2026 and 2027.
If you suspect non-compliance in relation to therapeutic goods, or their advertising, you can report it to the TGA at any time.
