TGA issues $71,280 in penalties over alleged unlawful melatonin imports
20 Aug 2026
Gezond Pty Ltd received two notices worth $39,600, while three pharmacists from Victoria and New South Wales received eight notices totalling $31,680. All three pharmacists are registered with the Australian Health Practitioner Regulation Agency.
The notices were paid in July and August 2026.
Under Australian law, therapeutic goods generally need to be listed on the Australian Register of Therapeutic Goods (ARTG) before they can be legally imported or supplied, unless an exemption or approval applies.
The melatonin products involved were not listed on the ARTG and did not have an applicable exemption or approval for import into Australia.
The TGA said unapproved therapeutic goods have not been assessed for quality, safety or effectiveness and may pose health risks. It has previously warned about imported melatonin products that contained different amounts of melatonin from those stated on their labels.
Professor Anthony Lawler, Deputy Secretary of the Department of Health, Disability and Ageing and head of the TGA, said supplying unapproved therapeutic goods was unacceptable and could put public health at risk.
The TGA said it would continue taking compliance and enforcement action against businesses and individuals who fail to meet their legal obligations.
Possible consequences for non-compliance include infringement notices, direction or prevention notices, and civil or criminal proceedings.
TGA issues $71,280 in penalties over alleged unlawful melatonin imports
Source: Therapeutic Goods Administration (TGA), Australian Government