Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2010-02-010 and -011 Neutralice

Meeting held 15 April 2010

1.      The complaint concerned two print advertisements. The first advertisement was published in the 23 January 2010 edition of New Idea magazine. The second advertisement was published in the 15 February 2010 edition of Woman’s Day magazine.

2.      The advertisements were substantially similar. Both were headed “NeutraLice – The NEW benchmark in head lice treatment” and included claims such as “New clinical research has proven that NeutraLice Lotion and NeutraLice Advance are almost 98% effective in KILLING head lice”, “this is the highest cure rate reported in the scientific literature for rigorous head lice study”, “kills head lice”, “clinically proven”, “visit www.neutralice.com.au for helpful hints and fun stuff for kids”, and “fast 10-minute application”.

3.      The advertisements also included a table, which stated that the NeutraLice Lotion and Spray Kit had a “% Cure Rate” of 97.62 percent, while the NeutraLice Advance Kit had a “% Cure Rate” of 97.56 percent.

4.      The second advertisement included an additional graphic stating, “STOP PRESS New in-vivo ovicidal study confirms NeutraLice Advance & Lotion also KILL EGGS”, and replaced the words “kills head lice and eliminates eggs (nits)” (from the first advertisement), with the words “kills head lice & eggs” on product images.

5.      An excerpt of the advertisements can be viewed in the relevant Appendix to this determination.

6.      The advertisement promoted the NeutraLice Natural Lotion Kit, the NeutraLice Natural Spray Kit, the NeutraLice Advance Lotion Kit, and NeutraLice Conditioner Shampoo.

7.      The advertiser was Key Pharmaceuticals Pty Ltd.

8.      The complainant, in relation to both complaints, requested anonymity but acknowledged representing a commercial competitor of the advertiser.

9.      The complainant raised substantially similar concerns in relation to both advertisements:

a)      That the words “the NEW benchmark in head lice treatment” breached section 4(5) of the Code by implying that the advertised product “provides the highest or equal highest cure rates for head lice when compared to any other head lice treatments on the market”;

b)      That the words “new clinical research has proven that NeutraLice Lotion and NeutraLice Advance are almost 98% effective in KILLING head lice” breached sections 4(2)(a) and 4(4) of the Code, because they “round[ed] the cure rates “up rather than down” and because the manner in which the research was conducted was not stated in the advertisement;

c)      That the references to “3 treatments” and “fast 10 minute application” breached sections 4(2)(a), 4(2)(c), and 4(4) of the Code because “the advertisement conveys the idea that you will only need 3 x 10 minute treatments to get a cure rate of >97%, when in fact the manufacturer’s instructions require the use of NeutraLice Conditioner Shampoo Lice Egg Remover daily between treatments, and a ‘treatment’ including the use of the included plastic lice comb to remove the dead headlice and their eggs”, and that “the presentation of the treatment regime only involving 3 x 10 minute treatments is misleading, not an accurate presentation of what a ‘treatment’ involves, and is likely to arouse unrealistic expectations of the products performance”;

d)     That the words “this is the highest cure rate reported in the scientific literature for a rigorous head lice study” breached section 4(1)(b), 4(2)(a), 4(2)(c), and 4(4) of the Code because they “implied that all scientific literature worldwide has been reviewed and that the cure rates reported in the advertisement for NeutraLice are higher than any found”, but that “it would not be physically possible to do such a review”, and furthermore that the same words implied “that the data presented in the advertisement for NeutraLice has itself been published in the scientific literature, and hence the study has been peer reviewed for scientific validity”;

e)      That the claim of a “97.62% cure rate” breached section 4(4) of the Code because it represented results relating to the lotion product as being applicable to the spray product, when the “two different delivery techniques... could conceivably alter the efficacy of the spray formula in relation to the lotion”;

f)       That the offer of free stickers in each pack, and the words “visit www.neutralice.com.au for helpful hints and fun stuff for kids” breached section 4(2)(j) of the Code; and,

g)      That the advertisements breached sections 6(3)(c), 6(3)(d), and 6(4) of the Code by lacking certain mandatory requirements.

10.  The complainant raised additional concerns in relation to the second advertisement as follows:

a)      That it included reference to a “new in-vivo ovicidal study” but that “no details about how the study was conducted are given in the advertisement” and “no details in regards to the researcher or financial sponsor of the ‘in-vivo ovicidal study’” were included, in breach of section 4(4) of the Code;

b)      That the claim that the advertised product can “kill eggs” is unacceptable for a Listed medicine and “is likely to arouse unwarranted and unrealistic expectations of product effectiveness and mislead the consumer”, in breach of sections 4(2)(a) and 4(2)(c) of the Code; and,

c)      That the claim that the NeutraLice Lotion product can “kill eggs”, combined with the footnoted words “Spray is an identical formulation to Lotion” conveyed an implication that the Spray product can also kill eggs, and that this representation is unacceptable for a Listed medicine and “is likely to arouse unwarranted and unrealistic expectations of product effectiveness and mislead the consumer”, in breach of sections 4(2)(a) and 4(2)(c) of the Code.

11.  By way of background, the advertiser advised the Panel of the following:

a)      That they had sponsored two studies, on relating to the pediculicidal efficacy of the advertised Lotion and Advance products, and one relating to the ovicidal efficiency of the same products; and,

b)      That the advertisements did not promote Listed medicines as alleged by the complainant, but rather promoted kit products which were included on the Register as medical devices.

12.  The advertiser argued that the “new benchmark in head lice treatment” should correctly be read in conjunction with the statements relating to 98% effectiveness and “the highest cure rate reported in the scientific literature”. The advertiser argued that when qualified by these additional statements, the “new benchmark” claim was “not an unqualified comparison of NeutraLice against all head lice products and/or an assertion that NeutraLice is the most effective product available but rather a comparison of the reported efficacy of NeutraLice against other head lice treatments which have been tested in like manner and reported in the scientific literature.” The advertiser also argued that the term “benchmark” is “a point of reference against which excellence is measured” and “is not an act of measurement or a statement of the known boundary of achievement”, and that the claim therefore only made the “assertion that the excellence or otherwise of other products will be measured (when they come to be measured) by reference to the standard obtained by NeutraLice”.

13.  In relation to the words “new clinical research has proven that NeutraLice Lotion and NeutraLice Advance are almost 98% effective in KILLING head lice”, the advertiser argued that the use of the word “almost” ought to allay any concern about the “rounding up” of the relevant figures, and that “it is not necessary or appropriate for advertisements of this kind to publish the study methodology in order to achieve balance and to avoid being misleading.”

14.  In relation to the references to “3 treatments” and “fast 10 minute application”, the advertiser stated that the efficacy rates cited in the advertisements had been obtained using three treatments as described in the table, and that any supplementary treatment with the Shampoo product would only enhance that level of efficacy.

15.  In relation to the words “this is the highest cure rate reported in the scientific literature for a rigorous head lice study”, the advertiser noted that these words were a quote from the relevant study, which was authored by “an internationally recognised expert who has authored many papers, is a referee of 50 international journals, and is a member of the 2005 Cochrane Review of Interventions for Treating Head Lice”. On the alleged implication “that the data presented in the advertisement for NeutraLice has itself been published in the scientific literature, and hence the study has been peer reviewed for scientific validity”, the advertiser stated, “when the advertisements were prepared it was never intended to imply that the studies had already been published”, but acknowledged that “some readers could conceivably draw that unintended conclusion.” The advertiser “under[took] to ensure that this is clarified in future advertising”, unless the study comes to be published.

16.  In relation to the complainant’s concern regarding the applicability of the research results to the Spray product, the advertiser stated as follows: “The NeutraLice Spray is simply the NeutraLice Lotion, sprayed onto the head rather than poured on the head. The products are identical in formulation.” The advertiser stated that the only difference in the instructions for use of the respective kits was that the Lotion product used the words “Apply a generous amount”, while the Spray product used the words “Spray a generous amount”. In both cases the directions advised users to “ensure hair is completely wet with lotion.”

17.  In relation to the alleged breach of section 4(2)(j) of the Code, the advertiser argued that the publications in which the advertisements appeared, and the language and focus of the advertisements, were such that the advertisements were clearly not directed to minors.

18.  In relation to the alleged breaches of sections 6(3)(c), 6(3)(d), and 6(4) of the Code, the advertiser acknowledged the breaches of sections 6(3)(c) and 6(3)(d) of the Code, but argued that no breach of section 6(4) had occurred because the advertisements were not in fact required to  be pre-approved.

19.  In relation to the additional matters raised by the complainant in relation to the second advertisement, the advertiser argued:

a)      That the advertised products are not Listed medicines but rather Class I procedure packs;

b)      That the findings of the ovicidal study “fully support the claim that NeutraLice Lotion and NeutraLice Advance are ovicidal”, killing 44.4 percent and 68.3 percent of eggs respectively;

c)      That the ovicidal claim would be understood by an ordinary consumer in an accurate fashion, and that the ovicidal claim was not unbalanced, misleading, or likely to arouse unwarranted expectations.

20.  As a preliminary matter, the Panel noted that the advertised Lotion, Spray, and Advance products were, as the advertiser stated, kits that were included in the Register as medical devices and not as medicines.

the words “the NEW benchmark in head lice treatment”

21.  Section 4(5) of the Code requires that comparisons made in advertisements must be balanced and must not be misleading or likely to be misleading, and prohibits the inclusion in advertisements of comparisons that “imply that the therapeutic goods, or classes of therapeutic goods, with which comparison is made, are harmful or ineffectual.”

22.  The Panel was satisfied that the words “NEW benchmark in head lice treatment” would be interpreted by an ordinary and reasonable consumer as meaning that the advertised products represented new, better products than any other products presently available. In representing a measure of results to constitute a “NEW benchmark”, the advertisement implied that the results exceeded any results which had gone before. Such an interpretation was supported by other words in the advertisement, such as the claim that the advertised products exhibited “the highest cure rate reported in the scientific literature.”

23.  The “NEW benchmark” claim was therefore a claim of absolute superiority over all other available products. On the basis of the material before it, the Panel concluded that this absolute claim was not balanced, and was misleading. This aspect of the complaint was therefore justified.

the words “new clinical research has proven that NeutraLice Lotion and NeutraLice Advance are almost 98% effective in KILLING head lice”

24.  Section 4(2)(a) of the Code prohibits representations that are “likely to arouse unwarranted and unrealistic expectations of product effectiveness”. Section 4(4) of the Code requires scientific information to be “presented in a manner that is accurate, balanced and not misleading”, and requires that publication of scientific research results should “identify the researcher and financial sponsor of the research.”

25.  The Panel did not accept the argument of the complainant that the words “almost 98%” were misleading because they “rounded up” the actual rates of effectiveness reported in the relevant study. It is entirely consistent with ordinary usage to describe figures of 97.63 percent and 97.56% as “almost 98%”. Moreover, the advertisement included the actual rates in a table very close to the “almost 98%” text.

26.  The table also showed that three treatments were required to achieve the relevant “cure rate”. The Panel did not accept the argument of the complainant that the claims were not accompanied by sufficient detail as to the methodology of the research, or misrepresented (for example, by omission of details as to “any missed eggs”) the outcomes of the research.

27.  The Panel was satisfied that adequate information identifying the researcher and sponsor of the research had been included in the advertisements.

28.  The Panel therefore found that these aspects of the complaint were not justified.

the references to “3 treatments” and “fast 10 minute application”

29.  Section 4(2)(c) of the Code prohibits representations that “mislead directly or by implication or through emphasis, comparisons, contrasts or omissions”.

30.  On the basis of the material before it, the Panel was satisfied that the representation of “cure rate” results arising from “three treatments” accurately represented the results obtained in the relevant study. The Panel noted that the lice combing component of the treatment process was not used in achieving the results reported in the study, as this could have confounded a comparison with other products that did not use combing.

31.  The Panel therefore did not agree that these references breached sections 4(2)(a), 4(2)(c), or 4(4) of the Code, and these aspects of the complaint were not justified.

the words “this is the highest cure rate reported in the scientific literature for a rigorous head lice study”

32.  Section 4(1)(b) of the Code requires that advertisements for therapeutic goods “contain correct and balanced statements only and claims which the sponsor has already verified.”

33.  The Panel noted that these words were based on text from the study referred to in the advertisement, and were qualified by reference to studies “that included the protocol elements advocated by the Therapeutic Goods Administration and Cochrane reviews”, and that such a qualification meant that conducting a suitable literature review would be less difficult.

34.  Critically, however, the Panel noted that the complainant was a commercial competitor of the advertiser, and therefore ought to have had little difficulty in providing the Panel with a study demonstrating that the claim in the advertisement was factually incorrect. On balance, and in the absence of any such submission from the complainant, the Panel was not satisfied that the “highest cure rate reported” claim breached sections 4(1)(b), 4(2)(a) or 4(4) of the Code as alleged by the complainant. These aspects of the complaint were therefore not justified.

35.  The Panel noted the additional argument of the complainant that the words “this is the highest cure rate reported in the scientific literature for a rigorous head lice study” could “imply that this data has in fact been peer reviewed and accepted for publication in the scientific literature”. The Panel agreed with the complainant that the words clearly conveyed such an implication, and that such an implication was misleading. The Panel therefore found that the words breached section 4(2)(c) of the Code, and this aspect of the complaint was justified.

the applicability to the Spray product of results relating to the Lotion product

36.  The complainant alleged that the advertisements breached section 4(4) of the Code by claiming that results obtained in relation to the Lotion product could also be expected in relation to the Spray product.

37.  While the Panel agreed with the complainant that, as a general proposition, differences in delivery methods could be of great significance in expected efficacy, in the present case the Panel was satisfied with the explanation provided by the advertiser. In particular, the Panel noted that in the case of both the Spray product and the Lotion product, the directions for use advised users to “ensure hair is completely wet with lotion” which, in the Panel’s view, strongly suggested that the hair being treated would be wet with lotion in the same way regardless of the delivery system. In the absence of a clear argument from the complainant (a commercial competitor of the advertiser) as to why the different delivery systems should yield different results in the case of the Spray product, the Panel found that this aspect of the complaint was not justified.

the alleged breach of section 4(2)(j) of the Code

38.  Section 4(2)(j) of the Code prohibits advertisements for therapeutic goods that are directed to minors, subject to some exceptions which were not applicable in the present case.

39.  The Panel did not agree with the complainant that the advertisements were directed to minors. While the products were obviously ordinarily intended for use on minors, the advertisements were in the Panel’s view directed to parents of minors, or other persons caring for minors. The fact that the products included stickers which were intended to appeal to minors did not mean that the advertisements were directed to minors. Such inclusions may be of assistance to parents or carers in making the administration of treatment more appealing to children and are not inappropriate.

40.  The Panel did not consider whether material on the website www.neutralice.com.au, such as a “colour in The Neutralizer!” game, could constitute advertising were directed to minors, as this material did not form part of the advertisements that were the subject of the complaint, and the question was not raised by the complainant.

41.  The Panel therefore found that this aspect of the complaint was not justified.

the alleged breaches of sections 6(3)(c), 6(3)(d), and 6(4) of the Code

42.  As the advertiser acknowledged, the advertisements breached sections 6(3)(c) and 6(3)(d) of the Code because the required statements “always read the label”, “use only as directed”, and “if symptoms persist consult your healthcare professional” were not included. These aspects of the complaint were therefore justified.

43.  The advertisements did not, however, breach section 6(4) of the Code as the complainant alleged, since the regulatory status of the advertised products (as included devices, and not as listed medicines), meant that they did not in fact require pre-approval. This aspect of the complaint was therefore not justified.

the reference to a “new in-vivo ovicidal study”

44.  The complainant alleged that the additional material in the second advertisement, concerning a “new ovicidal study” that “confirms NeutraLice Advance and Lotion also KILL EGGS” breached sections 4(2)(a), 4(2)(c), and 4(4) of the Code.

45.  The Panel was satisfied that this information breached sections 4(2)(a) and 4(2)(c) of the Code, but not for the exact reasons cited by the complainant. In the Panel’s view, by including the claim that the advertised products “also KILL EGGS” in a context where the “kill rate” or “cure rate” for head lice was explicitly and emphatically stated to be “almost 98%”, “97.62%”, and “97.56%”, the advertisement conveyed that lice eggs would also be killed at a rate approaching 98 or 100 percent. This was far from true, as the rate found in the relevant study was, according to the advertiser, 44.4 percent and 68.3 percent of eggs for the Lotion and Advance products respectively. In the Panel’s view the claim relating to the killing of eggs ought to have been suitably qualified to make it clear to consumers that the kill rate was significantly lower for eggs than for head lice. These aspects of the complaint were therefore justified.

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