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Date of Meeting: 02/08/12
Code: 2012/04/001
Product: NitWits
Complainant: Requested anonymity
Respondent: SI&D (Aust) Pty Ltd
Finding: Justified
Sections Found Justified: Act section 42DL(1)(g); Code sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d), 4(4), 4(5), 4(7)
Sections Found Not Justified: None
Action: Withdrawal of representations, Withdrawal of advertisement
Panel Determination:
COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2012-04-001 NitWits

Meeting held 2 August 2012

 




































Complaint summary^


Complainant


Requested anonymity


Advertiser


SI&D (Aust) Pty Ltd


Subject matter of complaint


Website advertisement


Type of determination


Final


Sections of the Code, Regulations or Act found to have been breached*


Act section 42DL(1)(g)

Code sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d), 4(4), 4(5), 4(7)


Sections of the Code, Regulations or Act found not to have been breached*


None


Sanctions

 


Withdrawal of representations

Withdrawal of advertisement


 

 

 

 

 

 

 

 


* only sections of the Code, Act, or Regulations that were part of the complaint or were raised by the Panel are listed
The advertisement(s)^


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

2.      The parts of the advertisement that were the subject of the complaint covered several pages. The pages included representations such as “head lice are the most common ailment in Primary Schools outside the common cold”, “head lice can be treated quickly and effectively”, “NitWits Natural have developed a range of head lice products, free from potentially harmful pesticides, using natural ingredients to effectively tackle head lice and their eggs. Products include treatments, defence sprays, and combs – to help you win the fight against nits”, “there are also products based on malathion, an organophosphate, and on synthetic pyrethrins. Some treatments also contain piperonyl butoxide and benzyl benzoate. These are all hazardous chemicals that are potentially harmful to the human health, and particularly harmful to children, babies and pregnant mothers”, “head lice prevention isn’t difficult, just simple steps applied to your daily routine to stop head lice infesting your children”, and many other claims.

3.      The advertisement referred to “a study conducted in Brisbane, Australia in 1997 [which] showed that head lice prevalence has risen to nearly 38%, and that the success rate of the common insecticide permethrin has dropped from 95% to about 60%”.

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


The product(s)


5.      The advertisement promoted NitWits Anti-Lice & Detangling Spray, NitWits Head Lice Comb, NitWits All-in-One Head Lice Action Cream, NitWits Head Lice Foam, and NitWits Combing Solution. However, the complaint was primarily concerned with the parts of the advertisement that promoted NitWits Anti-Lice & Detangling Spray and NitWits Head Lice Foam.


The advertiser(s)


6.      The advertiser was SI&D (Aust) Pty Ltd.


The complaint^


7.      The complainant requested anonymity.

8.      The complainant alleged that the advertisement breached section 4(2)(d) of the Code because of the representations “Nitwits Natural have developed a range of head lice products, free from potentially harmful pesticides”, “there are also products based on malathion, an organophosphate, and on synthetic pyrethrins. Some treatments also contain piperonyl butoxide and benzyl benzoate. These are all hazardous chemicals that are potentially harmful to the human health, and particularly harmful to children, babies and pregnant mothers”, and “free from potentially harmful pesticides”.

9.      The complainant alleged that the advertisement breached section 42DL(1)(g) of the Act because the advertised Anti-Lice & Detangling Spray product was not included in the Register.


Additional matters raised by the Panel


10. Under sub-regulation 42ZCAH(1), the Panel is empowered to raise matters other than those specified in the complaint, where the Panel is satisfied that the advertisement to which the complaint relates contains matter that is not mentioned in the complaint, which may contravene the Act, Regulations, or the Code in other ways. The Panel was so satisfied and raised the following additional matters:

 

a)      Possible breaches of section 4(5) of the Code because the advertisement may convey that other head lice products are harmful or ineffectual;

 

b)      Possible breaches of sections 4(4) and 4(2)(c) of the Code because representations about a study in Brisbane may be misleading or may not present scientific information or research results in a way that is balanced and accurate;

 

c)      Possible breaches of sections 4(7), 4(1 )(b), 4(2)(a), 4(2)(c) of the Code because of a testimonial stating that “all [lice were] dead on combing”;

 

d)     Possible breaches of sections 4(1 )(b), 4(2)(c) of the Code because of implicit representations that the advertised product is free from pesticides or is not a pesticide.

 


The advertiser’s response to the complaint^


11. The advertiser argued that in referring to “potentially harmful pesticides” they had ‘purposely included the word “potentially” as a qualifier’ and had not intended to cause alarm in consumers “but rather to draw attention to the fact that the products do not contain ‘pesticides’ according to the common usage of the word”.

12. In relation to the references to “hazardous chemicals that are potentially harmful to the human health”, the advertiser stated that they had amended the website to remove the words “hazardous chemicals” and “particularly harmful to children, babies, and pregnant mothers”.

 

13. In relation to the alleged breach of section 42DL(1)(g) of the Act, the advertiser argued that “this matter has been dealt with previously”, and referred to a “previous similar complaint considered by the Panel”.

14. In relation to the 1997 “Brisbane study”, the advertiser argued that the representations about it “are in accord with accepted opinion that resistance to permethrin (and indeed most insecticides with a long history of use) is common” and that “while degrees of resistance, and geographical locations of pockets of resistance, are subject to change, an acceptance of the concept of resistance to pediculocides is well established in the literature.” To further support this argument, the advertiser provided copies of an “updated study” published in 2003 that was said refer to the Brisbane study and, to support the concept of resistance, a 2006 paper investigating the mechanisms of resistance in head lice.

15. In relation to the testimonial material in the advertisement, the advertiser stated that the testimonial did not “necessarily lead to ‘unwarranted and unrealistic expectations of product effectiveness’” and that the testimonial stating that “all [lice were] dead on combing” reflected a “realistic treatment outcome”. The advertiser referred to a study on an earlier formulation of the advertised product in support of this.

16. The advertiser “concede[d] that any substance capable of killing pests… is strictly a pesticide” but they argued that they had used the term “in the common sense… that the product is free from ‘household’ synthesised chemical pesticides”. They stated that “to help clarify the intent of the statement”, they were prepared to use “alternate wording such as ‘free from chemical pesticides’ in place of the current statement.”



 


Findings of the Panel


17. Therapeutic goods are defined in the Act to include goods that are represented in any way to be for therapeutic use. Therapeutic use is defined to include use in or in connection with preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons, or influencing, inhibiting, or modifying a physiological process in persons.

18. The Panel was satisfied that head lice infestation constituted an “ailment”, and noted that the advertisement itself stated that “head lice are the most common ailment in Primary Schools outside the common cold”. The advertised Anti-Lice & Detangling Spray was promoted on a page headed “head lice prevention”, and included representations such as “prevention is a lot easier than what can be a frustrating experience to treat headlice”, “use a daily defence spray to ward off lurking head lice” (and the underlined words acted as a hyperlink to a page dedicated to the Anti-Lice & Detangling Spray product), “if there is a case at your child’s school pick up a NitWits Natural Anti-Lice & Detangling Spray. The natural repellents leave a protective shield warding off head lice”, and other claims. The same page included the words “always read the label” and “use only as directed”.

19. Moreover, the full range of NitWits products was stated to be “a range of head lice products… using natural ingredients to effectively tackle head lice and their eggs” and to include “treatments, defence sprays, and combs – to help you win the fight against nits”.

20. The Panel was satisfied that the advertised Anti-Lice & Detangling Spray was clearly represented in the advertisement to be for use in the prevention of an ailment, namely head lice infestation, and therefore to be for therapeutic use. In the context of the advertisement and complaint, the Anti-Lice & Detangling Spray therefore constituted therapeutic goods as defined in the Act.

21. Section 42DL(1)(g) of the Act prohibits the publication of advertisements for therapeutic goods that are not included in the Register. The Anti-Lice & Detangling Spray is not included in the Register. The advertisement therefore breached section 42DL(1)(g) of the Act, and this aspect of the complaint was justified.

22. Section 4(2)(d) of the Code prohibits advertisements which “abuse the trust or exploit the lack of knowledge of consumers or contain language which could bring about fear or distress.”

23. The complainant alleged that the advertisement breached this provision because of the representations “Nitwits Natural have developed a range of head lice products, free from potentially harmful pesticides” and “there are also products based on malathion, an organophosphate, and on synthetic pyrethrins. Some treatments also contain piperonyl butoxide and benzyl benzoate. These are all hazardous chemicals that are potentially harmful to the human health, and particularly harmful to children, babies and pregnant mothers”

24. The Panel was satisfied that such representations were likely to cause fear or distress in consumers, in relation to head lice products other than those promoted in the advertisement. This aspect of the complaint was therefore justified.

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

26. The Panel raised with the advertiser the possibility that representations about the “Brisbane study” could breach these provisions. The advertisement stated that the study “showed that head lice prevalence has risen to nearly 38%, and that the success rate of the common insecticide permethrin has dropped from 95% to about 60%.” These words appeared under the heading “natural head lice treatment”.

27. It should be noted that the advertiser did not provide a copy of the Brisbane study in response to the complaint, but rather provided an “updated study” published in 2003 that was said refer to the Brisbane study, which was conducted earlier.

28. The Panel found that an ordinary and reasonable consumer reading the advertisement would conclude that a study had been conducted in 1997 that involved the treatment of head lice infestation, that it had been large and comprehensive, and that the results (such as “the success rate of the common insecticide permethrin has dropped from 95% to about 60%”) could appropriately be extrapolated to the entire Australian community to which the advertisement was directed.

29. The 2003 study provided by the advertiser did not involve the treatment of head lice infestation, but rather the application of a number of pesticides to head lice in an in vitro setting. It did not disclose a clear pattern of resistance to permethrin but rather (as the authors of the study put it), showed that “the degree of susceptibility to these insecticides varied substantially among schools. Thus, a pediculicide that controlled lice at one school in Brisbane would not necessarily control head lice at another school in the same city.” The Panel accepted that, as a general proposition, it could be said that head lice can develop, and in some cases have developed, resistance to particular head lice treatments. However, the Panel did not find that the evidence provided by the advertiser could support the very specific claim that “the success rate of the common insecticide permethrin has dropped from 95% to about 60%”. This was especially so given that the evidence showed that the actual degree of resistance is highly variable even in locations that are quite close to one another.

30. The Panel was therefore satisfied that the claim that a scientific study had “show[n] that head lice prevalence has risen to nearly 38%, and that the success rate of the common insecticide permethrin has dropped from 95% to about 60%” was not accurate and balanced, and was misleading, in breach of sections 4(2)(c) and 4(4) of the Code. These aspects of the complaint were therefore justified.

31. 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.” The Panel was satisfied that the advertisement made comparisons with other head lice treatments, and represented them to be both harmful (because of references to harmful or pesticides), and ineffectual (because of the claim that permethrin has only a 60 percent “success rate”).

32. It should be noted that the Panel found the words “potentially harmful” to convey essentially the same meaning as “harmful” in the context of the advertisement and the complaint.

33. These aspects of the complaint were therefore justified.

34. 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.”

35. The Panel raised with the advertiser the possibility that the advertisement could breach sections 4(1)(b), 4(2)(c) of the Code because of implicit representations that the advertised product is free from pesticides or is not a pesticide. In response, the advertiser “concede[d] that any substance capable of killing pests… is strictly a pesticide” but argued that they had used the term “in the common sense… that the product is free from ‘household’ synthesised chemical pesticides”.

36. While the Panel understood the distinction that the advertiser intended to draw, the Panel did not find that the advertisement conveyed this distinction accurately. The Panel was satisfied that the advertised product was in fact a pesticide and that it was inaccurate and misleading to state that it was not a pesticide or was free of pesticides. These aspects of the complaint were therefore justified.

37. The Panel noted that the advertiser had proposed “alternate wording such as ‘free from chemical pesticides’”. While the Panel is unable to review proposed new advertisements, the Panel noted that, just as it was misleading to claim that the product was not a pesticide or was free of pesticides, it appeared to be equally misleading to claim that it was free of chemicals.

38. Section 4(2)(a) of the Code prohibits representations that are “likely to arouse unwarranted and unrealistic expectations of product effectiveness”. Section 4(7) of the Code requires that testimonials included in advertisements for therapeutic goods “must be documented, genuine, not misleading and illustrate typical cases only.”

39. The Panel raised with the advertiser the possibility that the advertisement could breach sections 4(1)(b), 4(2)(a), 4(2)(c), and 4(7) of the Code because of a testimonial. The testimonial stated: “I just want to say thank you for giving me the solution to horrible lice. I've tried them all, but yours is the best!! All dead on combing, very impressive!! Thanks for saving my mind!!”.

40. The evidence material provided by the advertiser in relation to this aspect of the complaint was an unpublished in vitro study. This was not, in the Panel’s view, adequate in type or scope to support a claim of 100 percent effectiveness in killing head lice in real world circumstances. The advertiser did not provide other evidence that the testimonial itself was documented, genuine, illustrative of typical cases only, and not misleading.

41. Moreover, given that the evidence provided by the advertiser, the Panel was not satisfied that equal effectiveness could be expected to be “typical” in relation to all head lice populations around Australia.

42. These aspects of the complaint were therefore justified.


Sanctions


43. The Panel requests SI&D (Aust) 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 Anti-Lice & Detangling Spray product is for any therapeutic use, including use in the prevention of head lice;

c)      to withdraw any representations that the advertised products are free of pesticides or are not pesticides, or that other head lice products may be harmful or ineffectual, together with the representation that a scientific study has “shown that head lice prevalence has risen to nearly 38%, and that the success rate of the common insecticide permethrin has dropped from 95% to about 60%” and the representations conveyed by the testimonial in the advertisement;

d)     not to use the representations in (b) and (c) above in any other advertisement*;

e)      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,

f)       within 14 days of being notified of this request, to provide evidence to the Panel of its compliance, including a response in writing that they will comply with the Panel’s sanctions, and where appropriate, supporting material such as copies of instructions to advertising agents or publishers, or correspondence with retailers and other third party advertisers.

44. 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.

Dated 30 October 2012

For the Panel

 

Jason Korke

Chairman




Appendix A:    Definitions and footnotes


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). It should be noted that HTML metatags and other information which can be retrieved by internet search engines, whether or not it is ordinarily viewed directly by consumers, constitutes advertisement material.

 

^Readers of the determination should note that the sections “complaint summary”, “the advertisement(s)”, “the complaint”, and “[a party]’s response to the complaint”, are summaries that are intended to aid readers of this document. In reaching its decision, the Panel considered all of the material before it, including material that may not be mentioned specifically in the summaries. The summaries do not form part of the Panel’s reasoning.

*Under regulation 42ZCAI of the Regulations, the Panel may request that a representation not be used in any other advertisement unless the advertiser 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. Under the Panel’s procedures, the Panel will not ordinarily give additional consideration to such a matter unless significant new material that was not available at the time of the Panel’s determination has become available, or until at least 12 months have passed since the Panel’s request was made.




Appendix B:     Excerpt of the Advertisement


 

 

 
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