Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2010-02-30 Nicabate

Meeting held 18 March 2010

1.      Readers of this determination should be aware that the material provided by both parties was extensive and is only summarised here. In particular, the parties provided material related to prior correspondence between them in relation to the same subject matter as the complaint, and material from a United Kingdom industry body concerning similar claims, neither of which the Panel regarded as relevant.

2.      The complaint concerned advertisements in different media including print, television, radio, and internet.

3.      The representation that was central to the complaint was generally worded as follows:

“Nicabate Mini 4mg lozenges release their full dose of therapeutic nicotine 3 times faster than gum.”

4.      The advertisements included a clarifying “disclaimer” which stated “speed of release does not infer speed of craving relief.”

5.      Excerpts of some of the advertisements can be viewed in the relevant Appendix to this determination.

6.      The advertisement promoted Nicabate Mini 4mg lozenges.

7.      The advertiser was GlaxoSmithKline Australia Pty Ltd.

8.      The complainant was Johnson & Johnson Pacific Limited, a commercial competitor of the advertiser.

9.      The complainant alleged that the advertisements breached sections 4(2)(a), 4(2)(c), and 4(5) of the Code.

10.  The complainant argued that there was a “take-out claim” from the advertisements which was “beyond that which is capable of support.” The complainant argued that “consumers reading the Claim without the disclaimer (whether because the Disclaimer is completely absent or simply not sufficiently prominent) would understand it to mean that:

·         the Minis lozenge format releases all nicotine from the lozenge three times faster than gum; and

·         as a result, the Nicabate Minis product will alleviate cravings, or begin to alleviate cravings, three times faster than NRT gum.”

11.  The complainant also argued that “the Claim clearly is intended to, and will be understood by consumers to convey, a corresponding benefit as a result of the lozenge’s increased rate of total release; given the emphasis on ‘3 times faster’, the Claim must be understood to mean that the product ‘works’ (that is, begins to alleviate or completely alleviates cravings) three times faster than gum”.

12.  The complainant argued that no representation regarding “the speed at which this dose is supported into the bloodstream, or the speed at which the product provides craving relief” was supported by the facts. The complainant stated that, at best, the facts only supported a claim about the speed at which the advertised product released “the full dose of therapeutic nicotine into the mouth”.

13.  The complainant also argued that the means by which the factor of “3 times” had been arrived at was misleading, since it compared a time of 10 minutes for the advertised product with 30 minutes for gum products, when in fact it should have compared a time of 10-13 minutes with 30 minutes. The complainant also argued that it was inappropriate to compare the time taken for the advertised lozenges to release their “full dose” with the time taken for gum products to release only part of their dose. The complainant argued that a claim of “1.5 to 3 times” or “2.3 to 3 times” faster release would be accurate, depending on which data was relied upon.

14.  The complainant also argued that “the Disclaimer does not properly qualify the Claim”.

15.  The complainant included a range of supporting material including a “consumer survey” which was purported to demonstrate that consumers had a particular view of the “3 times faster” claim.

16.  The advertiser stated that the “disclaimer” had been added to the advertisement “to reach a resolution” with the complainant prior to the complaint, and that they had not accepted that the claim was misleading.

17.  The advertiser noted that some of the advertisements provided by the complainant were no longer current.

18.  The advertiser argued that the “claim being communicated... to consumers is expressing the length of time taken for the 4mg Nicabate Mini lozenge to dissolve thereby releasing its nicotine, and for gum to be chewed thereby releasing its nicotine.” The advertiser stated that this was “purely a convenience claim”, but argued that “there are no published data that show that 4mg Nicorette gum relieves cravings in less than 15-20 minutes” and that “in comparison, Nicabate 4mg Minis are bioequivalent to 4mg Nicabate Lozenge which has been shown to relieve cravings in 5 minutes.”

19.  The advertiser reiterated that the claim was “quite clearly a convenience claim” and “is specifically communicating the convenience benefit of 10 minutes versus 30 minutes use by the consumer” and stated that they did not agree “that there is any other ‘take out’ from this claim.”

20.  The advertiser argued that the disclaimer was prominently displayed in the television and radio advertisements but stated that, nonetheless, they would “investigate ways of increasing the prominence of this statement in... advertising.”

21.  The advertiser took issue with the “consumer survey” conducted by the complainant and provided an analysis of the survey prepared by an expert in such surveys.

22.  The Panel did not give consideration to matters surrounding prior agreement between the parties as to the use of the disclaimer, nor to any decisions made by overseas industry bodies.

23.  The central question raised by the complaint was whether or not the claim that the “lozenges release their full dose of therapeutic nicotine 3 times faster than gum” (with or without minor variations in wording) breached sections 4(2)(a), 4(2)(c), and 4(5) of the Code, in the context of the advertisements in which the claim was made, including a context where the disclaimer “speed of release does not infer speed of craving relief” accompanied the claim.

the consumer survey

24.  As a preliminary matter, the Panel noted that the “consumer survey” provided by the complainant was unhelpful. The question relevant to the complaint asked survey respondents to “select the one benefit you think most accurately describes what this claim is trying to say about Nicabate Mini Lozenge.” Of the four benefits which could be selected, none conveyed the “take-out claim” which the advertiser argued was the “only” take-out claim supported by the facts. This meant that it was not possible for survey respondents to provide a response which matched the complainant’s view of the facts.

25.  The “consumer survey” therefore did not influence the Panel’s conclusions regarding the claim.

the evidence relating to the relative speed of nicotine release

26.  Although there was some dispute about the precise accuracy of the number three, it was apparent that both parties essentially agreed that the advertised product would release its nicotine content in approximately ten minutes, while gum products with which it was compared would require approximately 30 minutes of chewing if consumed according to their directions for use. Given its overall findings, the Panel did not consider it necessary to decide whether the precise factor for this time difference was 3, 2.3, 1.5, or some other number.

the “three times faster” claim

27.  Section 1(3) of the Code states that the Code should be interpreted with an emphasis on the object and the principles of the Code, and the total presentation and context of the advertisement. Section 3(2) of the Code states that the conformity of an advertisement with this Code should be assessed in terms of its probable impact upon the reasonable person to whom the advertisement is directed.

28.  After lengthy consideration, the Panel was satisfied that the words “Nicabate Mini 4mg lozenges release their full dose of therapeutic nicotine 3 times faster than gum” could, in a very narrow and technical sense, be regarded as true (subject to the issue noted in paragraph 26 above). It appeared to the Panel, based on the evidence provided by the parties, that the lozenge would no longer contain its dose of nicotine after approximately ten minutes, as it would have been released into the mouth, and that the corresponding time period for a gum product would be approximately 30 minutes.

29.  This did not, however, satisfy the question of whether the claim caused the advertisements to breach sections 4(2)(a), 4(2)(c), and 4(5) of the Code.

30.  Section 4(2)(a) of the Code prohibits representations that are “likely to arouse unwarranted and unrealistic expectations of product effectiveness”. Section 4(2)(c) of the Code prohibits representations that “mislead directly or by implication or through emphasis, comparisons, contrasts or omissions”. Section 4(5) of the Code requires, inter alia, that comparisons made in advertisements must be balanced and must not be misleading or likely to be misleading.

31.  A statement that is true in a narrow or technical sense may nonetheless be misleading, lack balance, or be likely to arouse unwarranted and unrealistic expectations in relation to a product’s effectiveness. The Panel was satisfied that the words “Nicabate Mini 4mg lozenges release their full dose of therapeutic nicotine 3 times faster than gum” would arouse in any reasonable consumer an expectation that the lozenges product would have an effect three times sooner than a competing gum product. Leaving the disclaimer aside, it appeared to the Panel that the “three times faster” claim would, on its own, breach sections 4(2)(a), 4(2)(c), and 4(5) of the Code.

32.  Moreover, other contextual elements of some of the advertisements were, in the Panel’s view, likely to reinforce such an interpretation on the part of consumers. The Panel noted that the television advertisement, for example, conveyed an impression that control of cravings was immediate – the advertisement’s protagonist replaced a cigarette with a lozenge and appeared to experience immediate craving relief. The “one cigarette at a time” motif running through many of the advertisements also suggested that relief was immediate. These contextual elements, in the Panel’s view, directed consumers minds to the speed of craving relief, and not merely to the speed with which nicotine was released, making consumers likely to connect the “three times faster” claim with the speed of craving relief.

the effect of the disclaimer

33.  The Panel reviewed the advertisements and noted that, generally, the disclaimer was not prominently displayed. In particular, the Panel noted that in the television advertisement, the disclaimer was virtually unreadable and appeared for an extremely brief period of time.

34.  Given its findings in relation to the “three times faster” claim, it was apparent that the necessary function of the disclaimer, “speed of release does not infer speed of craving relief”, was not merely to modify the claim in some minor way for clarification or precision. Rather, the necessary function of the disclaimer (if the disclaimer were to be effective) was to radically transform the likely interpretation made by consumers viewing the advertisements. In other words, to prevent the “three times faster” claim from being misleading and inaccurate by omission, the disclaimer would need to replace the consumer’s likely interpretation of the claim with a drastically different one.

35.  The Panel did not accept that the disclaimer fulfilled this function. In order to do so, the disclaimer would, in the Panel’s view, need to be of equal prominence to the claim itself – by appearing in the same general location, at the same size, and by being spoken in the same way.

36.  As the disclaimer was not prominent in this manner, the Panel was satisfied that the “three times faster” claim, even in advertisements where the disclaimer was present, breached sections 4(2)(a), 4(2)(c), and 4(4) of the Code. The complaint as a whole was therefore justified.

37.  As noted above, the Panel did not form a view as to the precise accuracy of the claim of “three times faster” release of nicotine. The precise factor of three was not in the event relevant to the Panel’s decision.  For this reason, the Panel advises the advertiser to ensure that the “three times faster” claim is supported by good evidence if it is used in future advertising, even if it is accompanied by a suitably prominent disclaimer.

38.  The Panel requests GlaxoSmithKline Australia Pty Ltd, in accordance with subregulation 42ZCAI(1) of the Therapeutic Goods Regulations 1990:

a)      to withdraw the advertisements from further publication;

b)      to withdraw the representation that the advertised product releases its nicotine three times faster than gum, unless that representation is suitably qualified by an equally prominent statement which makes it clear that the claim relating to the speed of nicotine release does not relate to the speed of craving relief;

c)      not to use the representation in (b) above in any other advertisement unless GlaxoSmithKline Australia 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, 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.

39.  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 28 April 2010

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).