The Therapeutic Goods Administration (TGA) has taken compliance action against Acacia Pharmacy Pty Ltd, issuing five infringement notices totalling $99,000 for the alleged unlawful importation of unapproved melatonin products. The infringement notices were paid in June 2026.
The TGA has also updated its safety advisory following an increase in the importation of counterfeit melatonin products.
The regulator reminds health practitioners, businesses and consumers that importing, supplying or distributing unapproved or counterfeit therapeutic goods is unlawful and may pose significant risks to public health.
Under the Therapeutic Goods Act 1989, therapeutic goods must generally be included in the Australian Register of Therapeutic Goods (ARTG) before they can be legally imported or supplied in Australia, unless a relevant approval or exemption applies. Products that are not listed on the ARTG have not been assessed by the TGA for quality, safety or efficacy.
The TGA encourages practitioners and businesses to understand their legal responsibilities when importing therapeutic goods. Failure to comply with the legislation may result in enforcement action, including infringement notices, regulatory directions, or civil or criminal proceedings.
This enforcement action forms part of the TGA’s ongoing compliance and regulatory activities to help ensure therapeutic goods and medical devices supplied in Australia meet legislative requirements, in line with its Compliance Principles 2026–2027.
Members who become aware of suspected non-compliance involving therapeutic goods or their advertising can report their concerns directly to the TGA.
Source: Therapeutic Goods Administration (TGA), TGA acts on melatonin import.
