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Date of Meeting: 01/03/12
Code: 2011/12/005
Product: Black Salve
Complainant: Requested anonymity
Respondent: Adrian Jones
Finding: Justified
Sections Found Justified: Act section 42DL(1)(g);Code sections 4(1)(a), 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c), 5
Sections Found Not Justified: None
Action: Publication of retraction, Withdraw advertisement; withdraw representations
Panel Determination:
COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2011-12-005 Black Salve

Meeting held 1 March 2012

 




































Complaint summary^


Complainant


Requested anonymity


Advertiser


Adrian Jones


Subject matter of complaint


Website advertisement


Type of determination


Final


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


Act section 42DL(1)(g)

Code sections 4(1)(a), 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c), 5


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


None


Sanctions

 


Withdrawal of representations

Withdrawal of advertisement

Publication of a retraction


 

 

 

 

 

 

 

 


* 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.adrianjonesnaturopath.com.au.

2.      The advertisement contained representations such as “Adrian Jones has had over 10 years experience of working with the Black Salve. He has treated a whole range of cancers from simple skin cancers to breast cancers and many others”, and “some of you, however, may want someone to ‘hold your hand’, as you try this Black Salve for the first time. Adrian is available to talk with you, via telephone and email or even face to face, to assist you through this process”. It made reference to “documented Black Salve success stories” in cases of squamous cell carcinoma, lentigo maligna melanoma, metastatic breast cancer, ductal carcinoma of the right breast, and basal cell carcinoma. It included a number of images of such conditions prior to treatment and after application of the advertised product.

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


The product(s)


4.      The advertisement promoted Black Salve.


The advertiser(s)


5.      The advertiser was Adrian Jones.


The complaint^


6.      The complainant requested anonymity.

7.      The complainant alleged that the advertisement breached sections 4(1)(a) and 5 of the Code, and sections 42DL(1)(g) of the Act.

8.      The complainant also expressed concern that the advertisement could result in incorrect diagnoses, incomplete clearance or treatment of lesions, and unnecessary late diagnosis and delay in treatment.

9.      The complainant also referred to a second website, www.blacksalve.com.au, but did not provide copies of any material from this website. The Panel therefore gave no consideration to this aspect of the complaint.

10. Two items of correspondence concerning the complaint were received by the Panel, one via a complaint form and the other by letter. The Panel decided to refer only to the letter as it had set out the specific sections of the Code which were alleged to have been breached, whereas the complaint submitted on the complaint form had not done so.

Additional matters raised by the Panel

11. Under sub-regulation 42ZCAH(1), the Panel is empowered to raise matters other than those specified in the complaint, where the Panel is satisfied that the advertisement to which the complaint relates contains matter that is not mentioned in the complaint, which may contravene the Act, Regulations, or the Code in other ways. The Panel was so satisfied and raised the following additional matters. For clarity, matters already raised by the complainant may be restated here.

 

a)      Possible breaches of section 42DL(1)(g) of the Act because the advertised product may not be included in the Register;

 

b)      Possible breaches of sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Code because of representations about the effects of the Black Salve product, including representations that it has therapeutic benefits of any kind, that it is appropriate for use by consumers, that it has benefits in connection with the treatment of cancers, “a whole range of cancers”, skin cancers, breast cancers, squamous cell carcinoma, lentigo melanoma, or any other cancers, and including the representations conveyed by the photographic images shown in the advertisement;

 

c)      Possible breaches of section 4(2)(b) of the Act because the advertisement may be likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases;

 

d)     Possible breaches of section 5 of the Code because the advertisement may include restricted or prohibited representations.


The advertiser’s response to the complaint^


12. The advertiser argued that the website material that was the subject of the complaint did not constitute an advertisement for therapeutic goods. The advertiser argued that they “had not ever supplied, nor... ever sold this product, nor advertised that it cures, treats or prevents cancer or ‘neoplastic (tissue)’ as prohibited or restricted by [the Code]”, and that “it is clear from [the] website that the wording in the contents expressly avoids stating that using Black Salve cures or prevents cancer”, and that “any link to any other site which may supply or sell Black Slave has been removed from [the] website”.

13. The advertiser argued that “the website is providing information of a generic nature about how Black Salve has been used in the past and present by many in Australia and around the world and the results they have obtained and testimonials are provided for information purposes.” The advertiser also argued that “there are... disclaimers on the website that clearly state that all who come onto the website should obtain further professional advice to verify the information on the website.” The advertiser stated that “the whole import of [the] website is journalistic only”.

14. In relation to the possible breaches of section 4(2)(b) of the Code, the advertiser argued that the website “promote just the opposite; biopsy is recommended”.

15. The advertiser wrote at some length about evidence for therapeutic goods generally, posing such questions as “Is photographic evidence not permissible any more? Do you want to totally discount what people are saying about this stuff? Courts of law rely on witness testimony; most people would?”, and stating that “[this] doesn’t prove anything; no single strand of evidence does. But when put together, these various strands make a very strong rope.” The advertiser argued that peer-reviewed, randomised controlled trials are not a reliable standard for assessing the efficacy of therapeutic goods, and pointed out that certain medicines have been found to be harmful or have side-effects after being made available to the public.

16. The advertiser did not provide full copies of any research material relating to the advertised product, but did provide some material that appeared to be excerpts from sources such as the website www.altcancer.com.


Findings of the Panel


17. 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 preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons, or influencing, inhibiting, or modifying a physiological process in persons.

18. It was clear that the black salve product was represented in the website material to be for therapeutic use, including use in the treatment, prevention, and cure of cancers.

19. An advertisement for therapeutic goods is defined in the Act to include “any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.”

20. The Panel was satisfied that a reasonable person viewing the advertisement would regard it as being intended to promote the use of the black salve product. Notwithstanding any “disclaimers” appearing on the site, it was in the Panel’s view clear that the website presented the black salve product as being efficacious and as offering successful results. It also offered assistance and guidance to users of the product.

21. Section 42DL(1)(g) of the Act prohibits the publication of advertisements for therapeutic goods that are not included in the Register. The black salve product is not included in the Register. The advertisement therefore breached section 42DL(1)(g) of the Act. This aspect of the complaint was 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)(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”.

23. The Panel reviewed the evidence provided by the advertiser. The Panel noted that the advertiser had provided essentially no evidence that the advertised product could have any of the benefits referred to in the advertisement, or indeed any therapeutic benefits at all. Rather, the advertiser had asserted that the product was supported by evidence, and argued that “science” and the “medical industry” were not reliable sources of information, referring to examples such as genetically modified food. The Panel did not find this material to be of relevance to the complaint or advertisement.

24. The Panel was satisfied that the advertisement contained many representations that had not been verified, were not correct and balanced, were likely to arouse unwarranted expectations about the advertised product, and were misleading, in breach of these provisions. These included the representations that has therapeutic benefits of any kind, that it is appropriate for use by consumers, or that it has benefits in connection with the treatment of cancers, “a whole range of cancers”, skin cancers, breast cancers, squamous cell carcinoma, lentigo melanoma, or any other cancers, and including the representations conveyed by the photographic images shown in the advertisement

25. These aspects of the complaint were therefore 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”. In the view of the Panel, the advertisement, through the words and images used, was very likely to lead consumers into self-diagnosing or inappropriately treating potentially serious diseases, including many forms of cancer. This aspect of the complaint was therefore 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. The Panel was satisfied that the advertisement breached section 5 of the Code because of numerous references to the treatment, cure, or prevention of cancers. This aspect of the complaint was therefore justified.


Sanctions


29. The Panel requests Adrian Jones, 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 black salve product is for any therapeutic use, or that it has any therapeutic effects, including effects in relation to cancers;

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.adrianjonesnaturopath.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.

30. 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 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.

 

^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.adrianjonesnaturopath.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.

 








 

RETRACTION

 

An advertisement for Black Salve, which we published on this website, should not have been published.

 

In the advertisement we promoted the use of black salve and offered assistance in using it. We claimed that Black Salve could have therapeutic benefits, including benefits in the treatment or cure of a wide range of cancers.

 

A complaint about the advertisement was recently upheld by the Complaints Resolution Panel. We provided no persuasive 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 also found that the advertisement was likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases.

 

The Panel therefore requested that Adrian Jones publish this retraction.

 

The attention of consumers is also drawn to the TGA warning at www.tga.gov.au/safety/alerts-medicine-black-salve-120203.htm

 

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, black and blue 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:


365 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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