COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2010-01-017 Avatar

Meeting held 18 March 2010

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

2.      The advertisement included claims such as “quickly assess the efficacy of supplements and treatment protocols”, “dynamically demonstrate improvements in the client’s condition by easily accessing past assessment for real time comparison while testing”, “determine potential allergens and stress factors for your client”, and “create effective treatment protocols that work”. It included references to doctors, chiropractors, dentists, naturopaths, kinesiologists, homeopaths, acupuncturists, veterinarians, nurses, nutritionists, and Chinese medicine practitioners.

3.      The advertisement also included a link to product information which led to extensive strong claims on a second website, www.veradyne.com. These claims included claims related to “autoimmune dysfunction and repair”, “infectious pathogens and immunity disorders”, “neurotoxicology and autoimmunity”, “acquired and innate immunity”, “homotoxicology as it relates to the immune response system”, “H5N1 viral (avian flu) energetic signature patterns”, “endocrine related autoimmune diseases”, “asthma, degenerative patterns, Crohn’s, vaccinations, leaky gut and other irritable bowel syndromes, diabetes mellitus type II, fibrosis, Graves, Hashimotos, hepatitis C, lupus, multiple sclerosis, H-pylori, and more”.

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

5.      The advertisement promoted the Avatar device.

6.      The advertiser was the Best Health Centre.

7.      The complainant requested anonymity.

8.      The complainant alleged that the advertisement breached sections 22(5), 41FN, and 42DL(1)(g) of the Act and sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d), 4(2)(g), 4(2)(h), and 5 of the Code.

9.      The complainant directed the Panel’s attention to various passages in the material in support of these allegations.

10.  The advertiser stated that they had removed the link second website, www.veradyne.com. They also stated that they had “removed any related links to statement in relation to ‘potential allergens’”, along with various other parts of the website which they believed “may have been inappropriate or incorrect.”

11.  They also stated that they had placed a retraction statement on their website in relation to the material that had been removed.

12.  They stated that they would “appreciate it greatly if the complainant or the panel could clarify the claims: ‘claims to give diagnosis’ and ‘is diagnosing’ and point [them] to specific URLs where these terms are used throughout the website” and stated that they would “be happy to remove any such statements and any other specific statements that are pointed out”.

13.  The advertiser also stated that they had been advised by the TGA devices branch that the advertised product “is not required to be included on the ARTG and is therefore not a therapeutic good” and provided correspondence in support of this.

14.  In relation to the specific sections of the Act and Code that were alleged to have been breached, the advertiser responded as follows:

a)      In relation to the alleged breaches of sections 4(1)(b) and 4(2)(c) of the Code, the advertiser acknowledged that some statements were “inappropriate”, but that they had since the complaint reviewed the website and removed any such statements, “thereby bringing [the site] back within the realms of the original confirmation from the devices branch”;

b)      In relation to the alleged breach of section 4(2)(d) of the Code, the advertiser stated that they did not believe it had been breached but that they had nonetheless removed any material mentioned in the complaint;

c)      In relation to the alleged breaches of sections 4(2)(g) and 4(2)(h) of the Code, the advertiser argued that they had not committed such a breach but were willing to remove any parts of the website which might be in breach if asked to do so;

15.  In relation to the alleged breach of section 5 of the Code, the advertiser appeared to be under the misapprehension that the complainant had alleged a breach of section 4(5) of the Code. Nonetheless they stated that they had removed any material mentioned in the complaint.

16.  In relation to the alleged breaches of sections 22(5), 41FN, and 42DL of the Act, the advertiser reiterated that they had received advice that the advertised product did not constitute therapeutic goods, and that they had removed those words on the site that related to therapeutic use.

17.  As a preliminary matter, the Panel considered the status of the material on the www.veradyne.com website, to which the advertiser’s website included a hyperlink. The Panel was satisfied that, in including the link in their website advertisement, the advertiser was in effect making the claims found in that material a part of their own advertisement. While it did not appear to the Panel that the advertiser had direct control over the material at the www.veradyne.com website, it was clear that the advertiser had control over the placement of links on their own website.

18.  The Panel noted that the advice from the TGA, referred to by the advertiser, had been made in response to a submission from the advertiser stating that the intended use for the advertised product was “to assess energetic imbalances within the Chinese Meridian System” and that “the process of meridian testing using the Avatar Technology is non-invasive and only assesses the meridians for energetic imbalances and/or stress and not disease”. The Panel did not give further consideration to this aspect of the advertiser’s response other than to note that (as the advertiser acknowledged) the advertisement material that was the subject of the complaint did not appear to be consistent with that submission.

19.  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 influencing, inhibiting, or modifying a physiological process in persons, and use in or in connection with preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals. The Panel noted that representations on either of the websites caused the advertised product to fall within the definition of therapeutic goods found in the Act.

20.  Clearly, the references on the www.veradyne.com related to “autoimmune dysfunction and repair”, “infectious pathogens and immunity disorders”, “neurotoxicology and autoimmunity”, “acquired and innate immunity”, “homotoxicology as it relates to the immune response system”, “H5N1 viral (avian flu) energetic signature patterns”, “endocrine related autoimmune diseases”, “asthma, degenerative patterns, Crohn’s, vaccinations, leaky gut and other irritable bowel syndromes, diabetes mellitus type II, fibrosis, Graves, Hashimotos, hepatitis C, lupus, multiple sclerosis, H-pylori, and more” constituted representations that the advertised product is for therapeutic use. Equally, the Panel was satisfied that the claims on the www.besthealth.com.au website describing the product as performing “electro-dermal screening”, “assess[ing] the efficacy of supplements and treatment protocols”, and “determin[ing] potential allergens and stress factors”, taken together and in the total context of the advertisement, represented the device as being for use in the diagnosis of ailments such as allergies.

21.  Section 42DL(1)(g) of the Act prohibits the publication of advertisements for therapeutic goods that are not included in the Register. The Panel noted that the product is not included in the Register,. The material therefore constituted a breach of section 42DL(1)(g) of the Act. The Panel therefore found this aspect of the complaint justified.

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

23.  In the absence of any evidence from the advertiser, the Panel was satisfied that the claims that the advertised product could have benefits in relation to the diagnosis or treatment of “autoimmune dysfunction and repair”, “infectious pathogens and immunity disorders”, “neurotoxicology and autoimmunity”, “acquired and innate immunity”, “homotoxicology as it relates to the immune response system”, “H5N1 viral (avian flu) energetic signature patterns”, “endocrine related autoimmune diseases”, “asthma, degenerative patterns, Crohn’s, vaccinations, leaky gut and other irritable bowel syndromes, diabetes mellitus type II, fibrosis, Graves, Hashimotos, hepatitis C, lupus, multiple sclerosis, H-pylori, and more” (as stated on the veradyne.com website) or  “determin[ing] potential allergens and stress factors” (as stated on the advertiser’s website) had not been verified, were not balanced or accurate, and were misleading. These aspects of the complaint were therefore justified.

24.  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 advertisement exploited the lack of knowledge of consumers by conveying that the device was capable of diagnosing or determining potential allergies. This aspect of the complaint was therefore justified.

25.  Section 4(2)(g) of the Code prohibits representations that therapeutic goods are “infallible, unfailing, magical, miraculous”, or that they are “a certain, guaranteed or sure cure”. Section 4(2)(h) of the Code prohibits advertisements for therapeutic goods that “contain any claim, statement or implication that it is effective in all cases of a condition”.

26.  The Panel did not find elements in the advertisement that appeared to support the alleged breaches of sections 4(2)(g), or 4(2)(h) of the Code. These aspects of the complaint were therefore not justified.

27.  Section 5(1) of the Code prohibits advertisements that “contain, expressly or by implication, a representation specified in Part 1 of Appendix 6.” The representations specified in Part 1 of Appendix 6 of the Code include representations regarding the treatment, cure, or prevention of neoplastic 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.

28.  It was clear that much of the material on the veradyne.com website, linked to from the advertiser’s website, breached section 5 of the Code. This aspect of the complaint was therefore justified.

29.  Sections 22(5) and 41FN(5) of the Act relate to advertisements for products which are included in the Register. As the advertised product is not included in the Register, they were not relevant to the present complaint. These aspects of the complaint were therefore not justified.

30.  The Panel noted, without making any formal finding, that it was likely that the advertisement had aroused unwarranted and unrealistic expectations of the product’s effectiveness in breach of section 4(2)(a) of the Code.

31.  The Panel requests Best Health Centre, 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 could have benefits in relation to the diagnosis or treatment of autoimmune dysfunction, infectious pathogens and immunity disorders, neurotoxicology and autoimmunity, “homotoxicology”, Avian flu, autoimmune diseases, asthma, degenerative disorders, Crohn’s disease, leaky gut, irritable bowel syndromes, diabetes, fibrosis, Graves’ disease, Hashimoto’s disease, hepatitis, lupus, multiple sclerosis, or H. pylori, or diagnosing or determining potential allergens and stress factors;

c)      not to use the representations in (b) above in any other advertisement unless Best Health Centre 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.besthealth.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.

32.  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 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).

An advertisement is to appear on the website www.besthealth.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.

No other copy should be included in the advertisement.

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