Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2008-09-014 Moov Head Lice Foaming Gel

Meeting held 20 November 2008

1.      The complaint concerned an internet advertisement published at the website www.egopharmaceuticals.com.au.

2.      The advertisement included a number of claims, including the claim that the advertised product is “perfect to be used at regular intervals to prevent infestation.”

3.      An excerpt of the advertisement can be viewed in the relevant Appendix to this determination.

4.      The advertisement promoted the Moov Head Lice range of products.

5.      The advertiser was Ego Pharmaceuticals Pty Ltd.

6.      The complainant requested anonymity.

7.      The complainant alleged that the advertisement breached section 42DM(1) of the Act and sections 4(2)(a) and 4(2)(f) of the Code.

8.      The complainant argued that the use of the word “prevent” in relation to head lice “creates an unrealistic expectation and may promote excessive use by consumers.”

9.      The advertiser stated that, in response to the complaint, the website had been amended to state “perfect to be used at regular intervals to help prevent infestation.”

10.  A TGA review of the regulation of head lice treatments, conducted by the Medicines Evaluation Committee in 2003, clarifies that Listed products for head lice may only make claims related to aiding in the management/control of head lice infestation, relieving the symptoms of head lice infestation, or aids in the removal of head lice and/or their eggs. They may not make claims relating to the prevention of head lice infestation.

11.  Section 4(2)(a) of the Code prohibits representations that are “likely to arouse unwarranted and unrealistic expectations of product effectiveness”. In the absence of any relevant submission from the advertiser, the Panel agreed with the complainant that the claim of “prevention” was likely to arouse unwarranted and unrealistic expectations of product effectiveness in breach of section 4(2)(a) of the Code. This aspect of the complaint was therefore justified.

12.  The Panel also noted that this problem was not corrected by the change made to the advertisement in response to the complaint, and that the word “helps” did not appear to alter the underlying meaning of the claim of “prevention”.

13.  Section 4(2)(f) of the Code prohibits representations that “encourage inappropriate or excessive use” of therapeutic goods. The Panel did not accept that the advertisement went so far as to encourage inappropriate or excessive use of the product. This aspect of the complaint was therefore not justified.

14.  Section 42DM(1) of the Act includes a requirement that advertisements for therapeutic goods comply with the Code. In view of the breach of section 4(2)(a) of the Code (above), this aspect of the complaint was justified.

15.  The Panel requests Ego Pharmaceuticals Pty Ltd, in accordance with subregulation 42ZCAI(1) of the Therapeutic Goods Regulations 1990:

a)      to withdraw the advertisement from further publication;

b)      to withdraw any representations that the advertised product can prevent head lice infestation;

c)      not to use the representations in (b) above in any other advertisement unless Ego Pharmaceuticals Pty Ltd satisfies the Panel that the use of the representation would not result in a contravention of the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 or the Therapeutic Goods Advertising Code;

d)      where the representation has been provided to other parties such as retailers or website publishers, and where there is a reasonable likelihood that the representation has been published or is intended to be published by such parties, to advise those parties that the representation(s) should be withdrawn; and,

e)      within 14 days of being notified of this request, to provide evidence to the Panel of its compliance, such as copies of instructions to advertising agents or publishers, or correspondence with retailers and other third party advertisers.

16.  The advertiser’s attention is drawn to the provisions of sub-regulations 42ZCAI(3) and (4) which permit the Panel to make recommendations to the Secretary in the event of non-compliance with this request, including a recommendation that the inclusion of the goods on the Register be cancelled.

Dated 12 January 2009

For the Panel

Jason Korke

Chairman

In this determination, unless otherwise specified:

a)      “the Act” means the Therapeutic Goods Act 1989;

b)      “the Regulations” means the Therapeutic Goods Regulations 1990;

c)      “the Code” means the Therapeutic Goods Advertising Code;

d)      “the Register” means the Australian Register of Therapeutic Goods;

e)      “any other advertisement” appearing in sub-regulation 42ZCA1(1)(d) is not confined to advertisements in specified or broadcast media (in relation to which complaints may be made to the Panel under Regulation 42ZCAB).