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Date of Meeting: 16/02/12
Code: 2011/11/017
Product: Macutec
Complainant: Requested anonymity
Respondent: Stiltec Pty Ltd
Finding: Justified
Sections Found Justified: Act section 22(5);Code sections 4(1)(a), 4(1)(b), 5(2)
Sections Found Not Justified: None
Action: Publication of retraction, Withdraw advertisement; withdraw representations
Panel Determination:
COMPLAINTS RESOLUTION PANEL DETERMINATION
Complaint 2011-11-017 Macutec
Meeting held 16 February 2012
 

Complaint summary
Complainant
Requested anonymity
Advertiser
Stiltec 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 22(5)
Code sections 4(1)(a), 4(1)(b),  5(2)
Sections of the Code, Regulations or Act found not to have been breached*
None
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 an internet advertisement published at the website www.macutec.com.au.
2.      The advertisement included extensive references to macular degeneration, blindness, “infectious diseases of the eye”, cataract, glaucoma, diabetic eye disease, and other health concerns. It stated that “Macular Degeneration (MD) is the most common cause of blindness in Australia... but early treatment can limit the damage for many people.” It described the advertised product as “a new standard in helping you deal with Macular Degeneration”, “based on today’s and tomorrow’s research and developed with significant input from some of Australia’s leading Ophthalmologists”, “a formulation of natural ingredients made in Australia to the pharmaceutical standard of Good Manufacturing Practice.” It stated that ingredients in the product could “reduc[e] the effects of age-related eye damage”, “help protect the macular region of the eye from age-related damage”, “increase the density of the protective macular pigment of the retina”, and “play a major role in protecting retinal tissues against oxidative stress”, and as being “important for eye health.”
3.      An excerpt of the advertisement can be viewed in the relevant Appendix to this determination.
The product(s)
4.      The advertisement promoted Macutec.
The advertiser(s)
5.      The advertiser was Stiltec Pty Ltd.
The complaint
6.      The complainant was anonymous.
7.      The complainant expressed the following concerns about the advertisement:
a)      That it implied that the advertised product was for the early treatment of macular degeneration, in breach of section 22(5) of the Act and sections 4(1) and 5(2) of the Code; and,
b)      That it breached section 5(2) of the Code because of other references to macular degeneration.
The advertiser’s response to the complaint
8.      The advertiser stated that the website had been amended in response to the complaint, with all references to macular degeneration removed from the site. The advertiser provided a copy of an amended website as part of their response.
Findings of the Panel
9.      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.”
10. The Panel was satisfied that the advertisement represented the Macutec product to be an early treatment for macular degeneration, and to be capable of protecting the eye against damage.
11. In the absence of any evidence from the advertiser, the Panel was satisfied that the claim that the advertised product could protect against macular damage or degeneration, or act as an early treatment for macular degeneration, had not been verified and was not correct and balanced. This aspect of the complaint was therefore justified.
12. 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.
13. The advertisement clearly made reference to a number of serious health concerns in breach of this provision. These included not only the references to macular degeneration, but also the references to blindness, “infectious diseases of the eye”, cataract, glaucoma, and diabetic eye disease. They also included the references to “age-related eye damage”, given the context of references to blindness and macular degeneration.
14. The advertisement therefore breached section 5(2) of the Code, and this aspect of the complaint was justified.
15. 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”.
16. The advertisement clearly promoted the Macutec product for indications other than those found in the Register for it, including the treatment of macular degeneration. This aspect of the complaint was therefore justified.
17. Section 4(1)(a) of the Code requires advertisements for therapeutic goods to comply with the statute and common law of the Commonwealth, States and Territories. Because of the breaches already noted, this aspect of the complaint was justified.
18. The Panel noted, without making any formal finding, that the advertisement appeared likely to breach section 4(6)(b) of the Code, because of references to ophthalmologists.
19. The Panel also noted, without making any formal finding, that the amended website submitted by the advertiser in response to the complaint appeared highly unlikely to comply with the Code, noting that it retained references to “age related macular degeneration”, “the most common cause of blindness”, “early treatment [that] can limit the damage for many people”, “age-related eye damage”, and “significant input from some of Australia’s leading Ophthalmologists”.
Sanctions
20. The Panel requests Stiltec 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 Macutec product protects against macular damage or degeneration, acts as an early treatment for macular degeneration, or treats or protects against conditions that can lead to eye damage or blindness, together with any representations that are references to blindness, infectious diseases of the eye, cataract, glaucoma, diabetic eye disease, or age-related eye damage;
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.macutec.com.au 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.
21. 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 15 June 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.
 
 
 
 
*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.macutec.com.au 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 Macutec, which we published on this website, should not have been published.
 
In the advertisement we unlawfully made claims that the Macutec product could protect the eye from age-related damage, including references to blindness, infectious diseases of the eye, cataract, glaucoma, diabetic eye disease, age-related damage that could cause blindness, and representations that Macutec can act as a treatment for macular degeneration.
 
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, unverified, and not correct or balanced, in breach of the Therapeutic Goods Advertising Code.
 
The Panel therefore requested that we 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:
120 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
 
 
 
Advertisement Copy: Download

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