COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2009-09-010 Germ Solutions 24

Meeting held 21 January 2010

1.      The complaint concerned an internet advertisement published at the website www.evolutionhealthsystems.com.au and a print advertisement published in the 17 June 2009 edition of the Courier Mail newspaper.

2.      The print advertisement stated as follows:

Germ Solutions

Combat Swine Flu

Germ Solutions 24 – “One Spray lasts all day”

Buy online

It also included the website address www.evolutionhealthsystems.com.au and a telephone number.

3.      The website advertisement was very extensive. It included claims such as “long lasting antimicrobial solutions”, “the following has been tested for hospital grade TGA approval”, “one spray for all day”, “the active ingredient is totally unique in structure”, “proven antimicrobial chemistry”, “not... removed by water”, “offers continuing antimicrobial protection”, “eliminates and inactivates bacteria, viruses, and fungi, but also prevents reinfection”, “eliminates not only bacteria but also viruses and fungi which can cause ringworm and fungal nail infections”, “[competing products] offer no residual germ-killing properties”, “the only product that remains on your hands for all day protection”, “moisturises as it protects”, “the problem with using other hand sanitizer products is that without the antimicrobial barrier provided by Germ Free 24, they just become a breeding ground for more germs”, “protects you from all types of germs all day long and actually makes your hands germ fighting machines”, “will retain its antimicrobial germ fighting capabilities for up to 64 hours [and] while the use of Germ Free 24 is recommended to be applied daily, the above testing indicates that even if you forget or are unable to apply the product due to travel or an emergency, you are still protected against infection and disease-causing germs”, “new and completely unique”, forms an invisible, odourless, moisturising layer that will not wash off”, “unsurpassed antimicrobial protection for hands”, “will kill all strains of Staphylococcus aureus including drug resistant MRSA strains”, “unlike any other product on the market today that can be applied to the hands”, together with many other claims.

4.      It also listed microorganisms such as Salmonella typhimurium, Listeria monocytogenes, campylobacter, Staphylococcus aureus, Pseudomonas aeruginosa, Clostridium difficile, Escherichia coli, “influenza A2”, “herpes simplex”, and many others.

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

6.      The advertisement promoted the product Germ Free 24 or Germ Solutions 24.

7.      The advertiser was Evolution Health Systems Pty Ltd.

8.      The complainant was anonymous.

9.      The complainant provided copies of numerous pages from the website advertisement as well as the print ad. The complainant stated that “the advertisement and the website look like they are bogus”, that the advertiser has “obvious difficulty with spelling organism names” and “seem to have copied and pasted some of their ‘legals’ from a car sales brochure or website.”

10.  The complainant also stated that the advertisements “allude[d] to TGA approval” and included “what appears to be extraordinary claims about their product”.

11.  The Panel considered the complaint to allege of breaches of sections 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c), 4(2)(d), 4(5), 4(6)(b), and 5(2) of the Code, and section 41FN(5) or 22(5) of the Act.

12.  In the interests of clarity the Panel advised the advertiser of this interpretation of the complaint.

13.  The advertiser expressed surprise in relation to the complaint, stating that they were “under the belief that the complaint had been resolved”.

14.  They stated that they had engaged a consultant to review their website.

15.  In relation to the claim regarding swine flu, the advertiser provided a copy of a test which, in the words of the advertiser, “definitively demonstrates... that Germ Solution Surface Spray Disinfectant Hospital Grade shows a log reduction of 4.42 with a reduction percentage of >99.996%”, and stated that this information “resolves the question of validity of the claim and removes the first part of the complaint.”

16.  The advertiser stated that “Germ Solution Hospital Grade (GSHG) is TGA certified... as an antimicrobial surface coating that inhibits the growth of bacteria, fungi (mould and mildew) and algae”, and provided a copy of the TGA listing document.

17.  In relation to the website, the advertiser provided evidence relation to test results involving four types of bacteria and stated that “all other references to other bacteria were removed on request [of the TGA]... prior to” the present complaint being received.

18.  The foregoing parts of the response appeared to be predicated on a view that the relevant aspects of the complaint related to the GSHG product.

19.  The advertiser provided further response material under the heading “Germ Solution 24 Hand Sanitiser”. The advertiser stated that “in relation to this section of the web site... [they had] delete[d] all the old information... and replaced it with a new structure.” They provided further evidence material in relation to this product.

20.  As a preliminary matter, the Panel made a number of observations in relation to the advertisements. The Panel noted that:

a)      The print advertisement clearly promoted a hand sanitiser and not a surface disinfectant product;

b)      The website material clearly represented the advertised product to be a hand sanitiser, although in some instances it also promoted a surface disinfectant; and,

c)      All of the claims made in the website material appeared to relate to the hand sanitiser product.

21.  The Panel also made a number of observations in relation to the response and evidence provided by the advertiser. The Panel noted that:

a)      Contrary to an apparent presumption made by the advertiser, the complaint in its entirety related to claims made about a hand sanitiser product and not about a surface disinfectant;

b)      The test information provided by the advertiser consisted of in vitro tests which clearly could not be relied upon to support claims of benefits lasting 24 or 64 hours for a product applied to the skin;

c)      The evidence did not extend to all of the microorganisms described in the advertisements; and,

d)     No evidence provided by the advertiser related to fungal infections.

22.  The Panel noted that the ARTG Certificate provided by the advertiser related to a disinfectant product categorised as “other therapeutic goods – Listed disinfectants”, and that such a Certificate could not be applied to a product sold as a skin disinfectant. For this reason, the Panel noted, without making any formal finding, that the advertisements appeared likely to breach section 42DL(1)(g) of the Act, which prohibits the publication of advertisements for therapeutic goods that are not included in the Register.

23.  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.” 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”.

24.  The nature of the evidence provided by the advertiser was such that, in the Panel’s view, it could not be relied upon to support the claims related to sanitisation of hands made in the advertisements, including the claims of benefits lasting 24 or 64 hours, or that it had benefits against the very wide range of microorganisms listed in the advertisements. The Panel also noted that the advertiser did not provide evidence to support claims that the product was “new” or “unique”.

25.  The advertisements therefore breached sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Code. These aspects of the complaint were justified.

26.  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 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.

27.  In the view of the Panel, the advertisements, through reference to swine flu and to an extremely large list of infectious microorganisms, was very likely to lead consumers into self-diagnosing or inappropriately treating potentially serious diseases, in breach of sections 4(2)(b) and 5(2) of the Code. This aspect of the complaint was therefore justified.

28.  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.” The Panel was satisfied that the advertisements exploited the lack of knowledge of consumers. This aspect of the complaint was therefore justified.

29.  Section 4(5) of the Code 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”, and requires that comparisons be “balanced and... not misleading or likely to be misleading”.  In the  absence of appropriate evidence from the advertiser the Panel was satisfied that the comparisons made in the advertisements to other hand sanitiser products were misleading. The Panel therefore found this aspect of the complaint justified.

30.  Section 4(6)(b) of the Code prohibits representations that goods are endorsed by government bodies. The Panel found that the advertisement represented the goods to be endorsed by a government body, namely the TGA. This aspect of the complaint was therefore justified.

31.  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”. Section 41FN(5) of the Code imposes a condition upon sponsors of medical devices that are included on the Register. Both section 22(5) and 41FN(5) relate to goods that are included in the Register. As the advertised hand sanitiser product is not included in the Register, the Panel found that these aspects of the complaint were not justified.

32.  The Panel noted, without making any formal finding, that the advertisement was likely to have breached sections 4(4) and 5(1) of the Code.

33.  The Panel requests Evolution Health Systems 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 product has benefits lasting for 24 or 64 hours, has benefits in relation to skin sanitising or disinfection, or in relation to the wide range of microorganisms listed in the advertisements, including swine flu, that it is “long lasting”, “new and completely unique”, “the only product that remains on your hands for all day protection”, “protects you from all types of germs all day long and actually makes your hands germ fighting machines”, “will retain its antimicrobial germ fighting capabilities for up to 64 hours”,  or “has been tested for hospital grade TGA approval”, that “the active ingredient is totally unique in structure” or has “proven antimicrobial chemistry”, “one spray [lasts] for all day”, “offers continuing antimicrobial protection”, “eliminates and inactivates bacteria, viruses, and fungi”, “prevents reinfection”, “eliminates not only bacteria but also viruses and fungi which can cause ringworm and fungal nail infections”, that “[competing products] offer no residual germ-killing properties”, or that “other hand sanitizer products... become a breeding ground for more germs”, that “even if you forget or are unable to apply the product due to travel or an emergency, you are still protected against infection and disease-causing germs”, and that it offers “unsurpassed antimicrobial protection for hands”, “will kill all strains of Staphylococcus aureus including drug resistant MRSA strains”, or is “unlike any other product on the market today that can be applied to the hands”;

c)      not to use the representations in (b) above in any other advertisement unless Evolution Health Systems 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;

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

f)       to arrange for publication in the Courier-Mail newspaper of a retraction in the form of, and in accordance with, the conditions set out in the attachment to this determination; and,

g)      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.

34.  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 7 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).

An advertisement to appear on the website www.evolutionhealthsystems.com.au at the earliest 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.

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