The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued two infringement notices totalling $26,640 to Perth-based company Bajaria Global Pty Ltd (Bajaria Global) for alleged unlawful importation of therapeutic goods containing betel nut under the Therapeutic Goods Act 1989 (the Act).
Bajaria Global allegedly imported two Pan Masala therapeutic goods for use in humans that contained betel (areca) nut. At the time of importation, the products were not included in the Australian Register of Therapeutic Goods (ARTG) and were neither exempt nor excluded from the operation of the Act. Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the ARTG before they can be lawfully imported into Australia.
Betel nut is the seed of the Areca palm (Areca catechu) and is a Schedule 4 (prescription only) medicine because it contains arecoline and related substances (see the Poisons Standard). The Indian Journal of Medical and Paediatric Oncology published a review of the systemic adverse effects of betel nut. The journal article indicates betel nut is an addictive substance associated with a range of harmful health effects, including mouth and throat cancer. Consuming betel nut while pregnant may also be harmful to the unborn baby.
The TGA’s highest priority is to protect the health and safety of the Australian public through the regulation of therapeutic goods.
The TGA takes action against breaches of the Act
The regulatory scheme is critical to the safety of Australian consumers, and the TGA investigates suspected illegal activity in relation to therapeutic goods. A range of compliance and enforcement tools are available and may include criminal or civil court proceedings, which can result in substantial penalties, fines or imprisonment.
If you suspect non-compliance, you can report illegal or questionable practices online to the TGA.