Generally, listed head lice products are unscheduled, meaning they can be sold freely in retail outlets and advertised to the public. Since 19 April 2000 (the date of introduction of the new Therapeutic Goods Advertising Code) listed products may only make “general” or “medium” level claims
head lice
Concerns about the safety and efficacy of currently available head lice treatments, and the suitability of the current system of regulation of these treatments, including the suitability of labelling guidelines, are the subjects of the Review.

There is a paucity of good-quality evidence supporting the effectiveness of many head lice treatments. In particular, there is very little published evidence on the efficacy of herbal head lice treatments. The Review recommends that the TGA seek evidence of efficacy from sponsors of these products for evaluation. Evidence suggests that currently available head lice preparations result in few side effects when used as directed, and additional restrictions or safety warnings are not warranted.
Head lice remedy,
There is little information in the literature regarding the effect of formulation on product efficacy. What evidence there is suggests that efficacy is formulation dependant, and therefore applications for new product registrations should be supported by clinical data on the formulation intended for marketing. In vitro data is not considered suitable in most
cases.
The Review considers that there are significant difficulties in translating the results of in vitro studies to conditions in the field.
There is evidence to suggest that resistance to the majority of active ingredients in head lice preparations either has or will develop in Australia as it has overseas. Further research into this issue is required, however, clinical studies undertaken overseas may not be applicable in Australia, as resistance patterns are likely to vary in different locations.

Current labelling guidelines, developed in the early 1990s, are in some areas out of step with evidence currently available in the literature. The Review recommends changes to the labelling guidelines, to restrict misleading or confusing claims, to enhance treatment effectiveness, and to provide additional evidence-based advice to consumers.

Chemical treatment is only one aspect of treating head lice infestation, and there is a clear need for good quality, authoritative information on all aspects of head lice infestation to be made available to the public.

In general, head lice products containing herbal ingredients such as melaleuca oil,lavender oil and eucalyptus oil are required to be listed on the ARTG. These products do not undergo evaluation for efficacy prior to listing, but product sponsors are required to possess evidence to support the claims made on the product label, and this evidence can be requested for assessment by the TGA. Listed products may only contain approved ingredients, which have been previously assessed for safety and quality.
Natural head lice treatments,

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