Australian Centre for Functional Medicine paid $59,400 over unapproved melatonin imports

The Therapeutic Goods Administration issued 12 infringement notices totalling $126,720 to 2 companies and 5 individuals for the alleged unlawful importation and advertising of prescription-only medicines, per its 6 October 2026 media release. The largest single recipient was The Australian Centre for Functional Medicine Pty Ltd, which received 3 notices amounting to $59,400 for importing unapproved melatonin products.

The products were not entered in the Australian Register of Therapeutic Goods (ARTG) and had no approval, authority or exemption permitting their importation — meaning they had never been assessed by the TGA for quality, safety or efficacy. The notices were paid between July and September 2026.

The same sweep penalised Chan and Khin Pty Ltd and a Queensland health practitioner $47,520 for advertising prescription medicines including lovastatin, baricitinib and ketamine, and several individuals for importing Mounjaro pens, prescription-only erectile dysfunction medicines and cosmetic injectables. TGA head Professor Anthony Lawler said goods must meet regulatory requirements before importation to protect consumers from products that may be unsafe, ineffective or of poor quality.

$59,400 in infringement notices (3 notices), paid between July and September 2026 — the largest single slice of a $126,720 sweep against 2 companies and 5 individuals.

A healthcare business built its offering on products that had never been assessed for Australian quality, safety or efficacy.

The clinic kept importing despite the requirement that therapeutic goods be ARTG-entered unless a specific exemption applies.

The infringement route let the TGA resolve the matter without prosecution — but at the highest per-entity amount in the sweep.

Buying therapeutic goods overseas does not transfer the compliance duty: the importer answers for ARTG entry, and 'it works for my patients' is not an exemption.

The notices were paid between July and September 2026, closing the infringement action. The TGA flagged that non-compliance can escalate to direction or prevention notices, civil penalties or criminal prosecution, and said it will continue strong enforcement where businesses do not meet their obligations.