TGA acts on melatonin imports with infringement notices totalling $99K

Laboratory testing of several imported unregistered melatonin products has confirmed them to be counterfeit under the Therapeutic Goods Act 1989. Now, the Therapeutic Goods Administration (TGA) has issued five infringement notices totalling $99,000 to a company for the alleged unlawful importation of unapproved melatonin products.

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

The TGA said this action reflects its ongoing compliance and enforcement activities for therapeutic goods and medical devices, as outlined in the TGA’s Compliance Principles 2026 and 2027.

Noting an increase in their importation, the TGA has published an updated safety advisory regarding counterfeit melatonin products, which you can read here.

The infringement notices were paid in June 2026.

Image credit: iStock.com/David McCue. Stock image used is for illustrative purposes only.