Australia's lice treatment device regulation

Abstract Background Before 2002, products for head lice were entered in the Australian Register of Therapeutic Goods (ARTG) as Registered or Listed Medicines, depending on the active ingredients. Since 2002, the Australian definition of a medical device has been consistent with that of the European Union, allowing many lice treatments and prevention products to be included in the ARTG as a Class 1 medical device (C1MD). Aim To analyse C1MD entries in the ARTG that incorporate the term ‘lice’ in their title, ingredient list, or indications. Method The ARTG was searched for entries using the term ‘lice’. Each entry's Public Summary was reviewed and C1MD entries were classified using Global Medical Device Nomenclature codes. Additional information about C1MD entries was sought by enquiry of sponsors, review of product websites, and examination of products at point of sale. Ethics approval was not required for this research as it involved publicly available information and did not involve human participants or human data. Results For only 20 of 31 C1MD entries for lice treatment or prevention were a complete list of ingredients or an active ingredient found from multiple information sources. Five C1MD entries had novel ingredients not in any medicine on the ARTG, and others contained an ingredient seemingly for a purpose not permitted in Listed Medicines. Conclusion In Australia, C1MDs designated for head lice treatment or prevention can be lawfully supplied without disclosure of their ingredients to the regulatory authority. Some C1MDs contained ingredients not found in any medicine on the ARTG. Additionally, some uses and indications of ingredients did not align with those permitted for Listed Medicines.