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Date of Meeting: 16/08/12
Code: 2012/04/023
Product: OmegaGen Cardio
Complainant: Requested anonymity
Respondent: Invida Australia Pty Ltd
Finding: Justified
Sections Found Justified: Act section 22(5); Code sections 4(2)(a), 4(2)(b), 4(2)(c), 4(2)(d), 4(2)(e), 4(7), 5(2)
Sections Found Not Justified: Code sections 4(4), 4(5), 5(1)
Action: Publication of a retraction, Withdrawal of representations, Withdrawal of advertisement
Panel Determination:
COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2012-04-023 OmegaGen Cardio

Meeting held 16 August 2012

 




































Complaint summary^


Complainant


Requested anonymity


Advertiser


Invida Australia Pty Ltd


Subject matter of complaint


Website and television advertisements


Type of determination


Final


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


Act section 22(5)

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


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


4(4), 4(5), 5(1)


Sanctions

 


Publication of a retraction

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 a television advertisement broadcast on Prime Television in April 2012, and an internet advertisement published at the website www.omegagencardio.com.

2.      The television advertisement consisted partly of testimonial material which contained representations such as “controlling my cholesterol has been a struggle for years… My bad cholesterol is down, good cholesterol is up”, “I wanted a natural solution so I turned to Omegagen Cardio, and it’s the first thing that actually worked for me”, and “I began taking Omegagen Cardio, and now my cholesterol levels are within the normal range”. It also included narration stating, “it’s the naturally sourced, clinically tested phospholipids in Omegagen Cardio that help support healthy cholesterol levels”, and “Take a natural strike at cholesterol with Omegagen Cardio”.

3.      The television advertisement also included a graphical animation, showing a capsule entering a stylised artery, which was shown to be connected to a heart. The inner wall of the artery was lined with a thick layer of a yellow substance that appeared to represent “cholesterol”.

4.      The internet advertisement included similar testimonial material (and included a hyperlink by means which the television advertisement could be viewed), together with representations such as “clinically tested, naturally sourced”, “help maintain healthy cholesterol levels and improve the HDL/LDL ratio within the normal range”, and other claims.

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


The product(s)


6.      The advertisement promoted the product Omegagen Cardio.


The advertiser(s)


7.      The advertiser was Invida Australia Pty Ltd.


The complaint^


8.      The complainant requested anonymity.

9.      The complainant alleged that the testimonials in the advertisements breached sections 4(2)(a), 4(5), 4(7), and 5(2) of the Code. The complainant also alleged that the testimonials “exceed the Listed indications”, which the Panel took to be an allegation of a breach of section 22(5) of the Act.

10. The complainant also alleged that the words “take a natural strike at cholesterol” caused the advertisements to breach section 5(2) of the Code, and that the words “clinically tested” caused the advertisements to breach sections 4(2)(a) and 4(4) of the Code.

11. The complainant alleged that a research paper published within the website advertisement referred to hyperlipidaemia, arteriosclerotic disease, and stroke, and therefore caused it to breach sections 4(2)(a), 4(2)(b), 4(2)(c), 4(2)(d), 5(1), and 5(2) of the Code. The complainant did not provide a copy of any page of the website showing all of these references, but the material provided did include a reference to hyperlipidaemia.

12. The complainant alleged that the graphical representation of an artery in the advertisements breached sections 4(2)(c), 4(2)(d), 4(2)(e), and 5(2) of the Code.

13. The complainant also alleged that the use of the term “cardio”, including its use within the product name, “carries implications beyond those included in the listed indications”, which the Panel took to be an allegation of a breach of section 22(5) of the Act.

14. The complainant referred primarily to the television advertisement in outlining the complaint, but also provided a copy of the website advertisement. Since the website advertisement contained a hyperlink via which the television advertisement could be viewed, the website advertisement contained all of the same representations as the television advertisement. However, it was also clear that the complainant had complained about elements of the website that were not also included in the television advertisement.


The advertiser’s response to the complaint^


15. The advertiser stated that the ARTG record provided by the complainant as part of the complaint (AUST L 162368) was not for the product appearing in the advertisement, and provided a copy of the correct ARTG record (AUST L 152089).

16. The advertiser argued that the advertisements did “reflect the Listed indications” for the advertised product (AUST L 152089).

17. The advertiser argued that the testimonials did not “refer to cholesterol levels/readings and therefore [did] not imply a person with problem cholesterol”, and that they were “consistent with the approved indications for the product.”

18. The advertiser also argued that the testimonials were “typical and representative of the ones being received by Invida; within the context of the claims/indications that are included on the ARTG; from Australians that are typical of the average population and healthy; [and] not from people that are portrayed as having serious cholesterol issues.”

19. The advertiser also argued that the television advertisement made no comparison with fish oil products, but rather referred to “no fishy aftertaste”, which consumers may be concerned about as the product is derived from seafood.

20. The advertiser argued that, in relation to the testimonials, the advertisements did not “refer or imply a link to a serious form of disease”, and that “the copy in this ad is within the approved indications of the product”. The advertiser also argued that the claim “take a natural strike at cholesterol” was “a call to action for people that may need to help maintain healthy cholesterol levels”.

21. The advertiser stated that the representations about product benefits were based on three published clinical trials, and that the term “clinically tested” was therefore appropriate. The advertiser also advised that “the use of the term ‘clinically tested’ is within the listed indications for the product”.

22. The advertiser stated that “no scientific information” was presented in the television advertisement and that section 4(4) of the Code was therefore not applicable. In relation to the clinical paper published on the website, they stated that, “it is publicly available and identifies the researchers and sponsor of the research” but also advised that the material “may not be suitable for a consumer environment and has now been removed”.

23. In relation to the animated graphic in the television advertisement, the advertiser stated that they “disagree[d that] the visual of the artery has ‘significant’ deposits” and therefore did not agree that it caused the advertisement to breach the Code.

24. In relation to the term “cardio” in the product name, the advertiser stated that this was appropriate as it is consistent with the “approved indications” of the product, specifically “clinically proven for cholesterol and heart health”.


Findings of the Panel


25. 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. In assessing the advertisements, the Panel was mindful not only of the particular words cited by the complainant, but of the entire context of each advertisement and its likely impact on a reasonable consumer.

preliminary matters

26. The Panel noted that there was a clear disagreement between the complainant and the advertiser on the question of whether the advertisements (and especially the testimonials and visual imagery) made reference to serious health concerns. The complainant alleged that the advertisements referred by implication to “serious forms of diseases”, while the advertiser argued that they referred only to balancing or maintaining cholesterol levels in people without serious cholesterol problems.

27. After careful review of the advertisements, the Panel was satisfied that the television advertisement (which was also part of the website) referred by implication to serious cholesterol problems. The Panel was satisfied that a reasonable consumer viewing the advertisement would conclude that a woman for whom “controlling… cholesterol has been a struggle for years”, and who was pleased that her “bad cholesterol is down, good cholesterol is up”, would most likely be experiencing a cholesterol problem. Similarly, the statement that, after commencing use of the advertised product, “now my cholesterol levels are within the normal range” would convey to any reasonable consumer that the speaker’s cholesterol levels were previously not within the normal range, and the words “it’s the first thing that actually worked for me” would, in the context of the advertisement, be taken by a reasonable consumer to mean that the advertised product had “worked” to restore healthy cholesterol levels for the speaker. In the case of all three testimonials, therefore, the Panel was satisfied that the testimonials referred to serious cholesterol problems.

28. Moreover, the Panel was satisfied that the stylised artery in the advertisement was in fact lined with a substantial amount of “cholesterol” – depending on a viewer’s interpretation of the imagery, as much as half of the interior diameter of the “artery” was blocked. In the context of the advertisement, the imagery reinforced a view that the speakers were referring to serious cholesterol problems.

compliance with section 22(5) of the Act

29. Section 22(5) of the Act states that sponsors of therapeutic goods “must not, by any means, advertise the goods for an indication other than those accepted in relation to the inclusion of the goods in the Register”.

30. The indications for the advertised product did not extend to serious cholesterol problems, but rather to the maintenance of cholesterol within the normal range and the improvement of HDL/LDL ratios. For the reasons noted above, the Panel was satisfied that the television advertisement represented the product to be of therapeutic benefit in the lowering of cholesterol or the treatment of serious cholesterol problems. The advertisements therefore breached section 22(5) of the Act, and this aspect of the complaint was justified.

31. The Panel also noted that the advertiser, when responding to several of the alleged breaches of the Therapeutic Goods Advertising Code, had argued that certain representations within the advertisement were "consistent with the approved indications for the product" and appeared to take a view that this argument addressed concerns about the accuracy of the representations, or the degree to which the representations were supported by evidence. As noted above, the Panel was satisfied that a number of representations in the advertisements were beyond the scope of the indications on the Register for the advertised product. Moreover, the Panel noted that the inclusion of an indication on the Register for an advertised product is not in itself evidence that the representation is accurate, verified, or not misleading. Representations made in advertisements must be supported by robust evidence even where they are included in the Register.

the testimonial material

32. Section 4(2)(a) of the Code prohibits representations that are “likely to arouse unwarranted and unrealistic expectations of product effectiveness”.

33. The complainant alleged that the testimonials in the television advertisement breached this provision because they carried “a clear implication of lowering cholesterol levels and improving HDL/LDL ratios in people with problem cholesterol”. The Panel was satisfied that the advertisement conveyed such an implication, and that in doing so it was likely to arouse unwarranted and unrealistic expectations of the product’s effectiveness. This aspect of the complaint was therefore justified.

34. 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.”

35. The complainant argued that the television advertisement breached this provision because of a “misleading comparison with fish oil products”. The Panel did not find that the advertisement conveyed such a comparison, and noted that the reference to a “fishy aftertaste” was a reasonable one to make when advertising a krill oil product. This aspect of the complaint was therefore not justified.

36. 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”, and that they must otherwise comply with the Code. Given the breaches already noted, it was clear that the testimonials in the television advertisement breached this provision, and this aspect of the complaint was therefore justified.

37. Section 5(2) of the Code prohibits advertisements that “refer, expressly or by implication, to serious forms of diseases, conditions, ailments or defects specified in Part 2 of Appendix 6, unless prior approval is given under the Therapeutic Goods Act 1989.” The diseases and conditions specified in Part 2 of Appendix 6 of the Code include “serious forms of” a wide range of health concerns.

38. For the reasons already noted, the Panel was satisfied that the television advertisement made reference to serious forms of certain health concerns, such as hypercholesterolemia, cholesterol levels that could not be controlled without “struggle”, or cholesterol levels outside the normal range. Such conditions are considered to be forms of cardiovascular diseases, which is included in Table 1 of Part 2 pf Appendix 6 of the Code. The advertiser did not provide evidence of prior approval to use such terms under the Therapeutic Goods Act 1989. Therefore, this aspect of the complaint was justified.

“take a natural strike at cholesterol”

39. The complainant alleged that the words “take a natural strike at cholesterol” conveyed an implication that the product could aid in cholesterol lowering, in breach of section 5(2) of the Code. While the words would not, in the Panel’s view, necessarily convey such an implication in all contexts, the Panel was satisfied that in the context of the television advertisement, the words did in fact convey such an implication, and that the implication brought the advertisement within the scope of section 5(2) of the Code. This aspect of the complaint was therefore justified.

“clinically tested”

40. 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.”

41. The complainant alleged that the advertisements breached section 4(2)(a) and 4(4) of the Code because the advertised product was described as “clinically tested”, and argued that “this statement exaggerates the degree of evidence available.” The advertiser stated that the claim was supported by clinical research, but provided no evidence such as copies of studies or other material, although such material had been requested by the Panel.  In the absence of an appropriate response from the advertiser, the Panel was satisfied that the claim that the product was “clinically tested” breached section 4(2)(a) of the Code.

42. However, the Panel did not find the words to constitute “scientific information” or the publication of scientific research results, and therefore did not find them to breach section 4(4) of the Code. This aspect of the complaint was not justified.

the research paper

43. Section 4(2)(b) of the Code prohibits advertisements that are “likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases”. Section 4(2)(c) of the Code prohibits representations that “mislead directly or by implication or through emphasis, comparisons, contrasts or omissions”. 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.” Section 5(1) of the Code prohibits advertisements that contain, expressly or by implication, a representation set out in Part 1 of Appendix 6 of the Code.

44. The complainant alleged that the website advertisement breached sections 4(2)(a), 4(2)(b), 4(2)(c), 4(2)(d), 5(1) and 5(2) of the Code, because it included a full copy of a research paper referring to hyperlipidemia, arteriosclerotic disease, and stroke. The complainant did not include a copy of any page of the website that included such material, but did include a page that made reference to hyperlipidemia through the use of the title of a study, “Evaluation of the Effects of Neptune Krill Oil on the Clinical Course of Hyperlipidemia”.

 

45. The Panel was satisfied that the website advertisement breached sections 4(2)(a), 4(2)(b) and 5(2) of the Code because the use of the word “hyperlipidemia”, in the context of the advertisement as a whole, clearly made reference to a serious form of a cardiovascular disease, was likely to lead consumers to inappropriately treat such a disease, and implied that the product could lower blood lipid levels when such a benefit had not been substantiated with clear evidence. These aspects of the complaint were therefore justified.

46. The Panel did not find that the reference to hyperlipidemia caused the website advertisement to breach sections 4(2)(d) or 5(1) of the Code, and these aspects of the complaint were therefore not justified.



 

the graphical representation of an artery

47. Section 4(2)(e) of the Code prohibits representations that are likely to lead persons to believe that they are suffering from a serious ailment or that harmful consequences may result from advertised products not being used.

48. The complainant alleged that the “graphical representation of an artery with significant deposits of cholesterol” in the television advertisement caused it to breach sections 4(2)(c), 4(2)(d), 4(2)(e), and 5(2) of the Code.

49. The Panel was satisfied that the graphical representation of an artery with an apparent thick layer of cholesterol deposits amounted to a reference to serious arterial disease, and that in the context of the advertisement it was likely to mislead consumers, cause them to believe that they (as ordinary, healthy consumers) could be suffering from a serious ailment, and cause fear or distress. The advertisement therefore breached sections 4(2)(c), 4(2)(d), 4(2)(e), and 5(2) of the Code, and these aspects of the complaint were justified.

the term “cardio”

50. The complainant alleged that the “product name including the word ‘cardio’” constituted a reference to a serious health concern that caused the advertisements to breach section 5(2) of the Code. The Panel was satisfied that the term “cardio” would be taken to mean that the advertised product had some benefit for the heart, and did not necessarily constitute a reference to a serious health concern. This aspect of the complaint was therefore not justified.


Sanctions


51. The Panel requests Invida Australia 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, including implied representations, that the advertised product offers benefits in connection with cholesterol levels outside the normal healthy range, lowering cholesterol levels, lowering cholesterol levels and improving HDL/LDL ratios in people with problem cholesterol, controlling or managing cholesterol levels for consumers who have had difficulty controlling or managing cholesterol levels, or being “clinically proven”, together with any representations referring to hyperlipidemia or other serious health concerns;

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

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;

e)      to arrange for publication on the website www.omegagencardio.com of a retraction in the form of, and in accordance with, the conditions set out in the attachment to this determination; 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.

52. 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 4 December 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:     Retraction


 

An advertisement is to appear on the website www.omegagencardio.com at the earliest booking opportunity.

 

A copy of the retraction advertisement, and the page on which it will be published, is to be provided to the Complaints Resolution Panel for approval before publication.

 








 

RETRACTION

 

An advertisement for Omegagen Cardio, which we published on this website and broadcast on television, should not have been published or broadcast.

 

In the advertisement we unlawfully made claims that the product could have benefits in lowering cholesterol, balancing cholesterol levels for consumers with cholesterol problems, or restoring cholesterol levels for consumers whose cholesterol levels are outside the normal, healthy range.

 

A complaint about the advertisement was recently upheld by the Complaints Resolution Panel. We provided no evidence to support the claims we made, and the Panel found that the claims were unlawful, misleading, and unverified and breached the Therapeutic Goods Advertising Code.

 

The Panel therefore requested that Invida Australia Pty Ltd publish this retraction.

 

The full text of the Panel’s determination can be found at: www.tgacrp.com.au/complaints

 


 

No other copy should be included in the advertisement.

 

































Location:


website front page, so that it can be viewed without scrolling the page


Size:


No less than 500 pixels wide and 200 pixels high


Heading:

 


Arial or Helvetica

Red on a white background

The letters should be no less than 20 pixels in height, and should be no smaller than any other body text on the page

Bold


Text:


Arial or Helvetica

Red on a white background

The letters should be no less than 14 pixels in height, and should be no smaller than any other body text on the page

Bold


Text Box:


Red on a white background


Duration:


90 days


HTML


In the case of website retractions, the retraction is to be presented in ordinary and valid HTML 4 in the body of the page. Pop-ups, Flash objects, or images are not acceptable formats for website retractions.



Appendix C:    Excerpt of the Advertisement


 

 

 

 
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