TGA acts on melatonin imports

The Therapeutic Goods Administration (TGA) has issued 5 infringement notices totalling $99,000 to Acacia Pharmacy Pty Ltd for the alleged unlawful importation of unapproved melatonin products, in contravention of the Therapeutic Goods Act 1989 (the Act).

The infringement notices were paid in June 2026.

Importing, supplying and/or giving away counterfeit melatonin products is illegal and poses a significant public health and safety risk.

The TGA has published an updated safety advisory regarding counterfeit melatonin products, as there has been an increase in their importation.

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 included in the ARTG and had no exemptions or approvals that permitted their importation or supply in Australia.

Therapeutic goods which have not been included in the ARTG have not been assessed by the TGA for quality, safety and efficacy and may pose a health risk.

Individuals, health practitioners and businesses must understand their legal obligations under the Act before importing therapeutic goods. Consequences for 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.

Contact for members of the media:

• Email: news@health.gov.au  
• Phone: 02 6289 7400