TGA issues penalties over unlawful melatonin imports

TGA issues penalties over unlawful melatonin imports

15 Jul 2026

The TGA said importing, supplying or distributing counterfeit melatonin products is illegal and may pose a serious risk to public health. It has also released an updated safety advisory following an increase in the importation of these products.

Under Australian law, therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be legally imported or supplied, unless a specific approval or exemption applies. The melatonin products involved were not listed on the ARTG and did not have the required approvals or exemptions.

The TGA warned that products not assessed for inclusion in the ARTG have not been evaluated for their quality, safety or effectiveness, meaning they may present health risks to consumers.

The regulator is reminding individuals, healthcare professionals and businesses to understand their legal responsibilities before importing therapeutic goods. Failure to comply with the legislation may result in infringement notices, regulatory directions, or civil and criminal enforcement action.

The enforcement action forms part of the TGA's ongoing compliance activities under its Compliance Principles 2026–2027.

TGA issues penalties over unlawful melatonin imports

Source: Therapeutic Goods Administration (TGA)

 

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