Complaints Resolution Panel
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  Thursday 31 July 2014
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Date of Meeting: 02/02/12
Code: 2011/11/003
Product: Cararthron
Complainant: Dr Ken Harvey
Respondent: Chalmer Dale and Co Pty Ltd
Finding: Justified
Sections Found Justified: Code sections 4(1)(b), 4(2)(a), 4(2)(c)
Sections Found Not Justified: None
Action: Publication of retraction, Withdraw advertisement; withdraw representations
Panel Determination:

COMPLAINTS RESOLUTION PANEL DETERMINATION

 

Complaint 2011-11-003 Cararthron

 

Meeting held 2 February 2012

 

 

Complaint summary

 

Complainant

 

Dr Ken Harvey

Advertiser

 

Chalmers Dale and Co Pty Ltd

Subject matter of complaint

 

Website advertisement

Type of determination

 

Final

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

 

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

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.cararthron.com.au.

2.      The advertisement included representations such as “helps provide relief of pain and stiffness associated with rheumatoid and osteoarthritis, and may help improve overall joint function”, “the new natural alternative is Cararthron for helping to alleviate symptoms of arthritis”, “Cararthron also helps to maintain healthy cardiovascular function”, “new improved formula of a clinically tested natural product for arthritis relief”, “Cararthron has been clinically tested”, “regular intake over 4-12 weeks results in an improvement of mobility and a reduction in stiffness”, and many others.

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

The product(s)

 

4.      The advertisement promoted the product Cararthron.

The advertiser(s)

 

5.      The advertiser was Chalmers Dale and Co Pty Ltd.

The complaint

 

6.      The complainant was Dr Ken Harvey.

7.      The complainant alleged that the advertisement breached sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Code.

8.      The complainant referred to research material regarding ingredients of the advertised product, noting that the evidence was limited and that the researchers explicitly stated that further research was required.

9.      The complainant directed the Panel’s attention to a previous complaint, 2010-09-015 Cararthron.

The advertiser’s response to the complaint

 

10.  The advertiser stated that the representations questioned by the complainant had been “extracted from an approved advertisement” and that “the specific indications for Cararthron have been approved by the TGA.”

11.  The advertiser provided copies of “relevant papers” from a “library of scientific published papers” said to support the representations made in the advertisement.

Findings of the Panel

 

12.  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”.

13.  The Panel reviewed the evidence material provided by the parties. The Panel formed a view of the evidence that was consistent with its view in relation to a previous complaint referred to by the complainant, 2010-09-015 Cararthron. In relation to that complaint, the Panel found that:

it was clear that the material fell very far short of supporting the claims made in the advertisement. The study upon which the advertiser primarily relied, the Levy et al study, was expressly stated by its authors to be a short-term pilot study. It could not plausibly be advanced in support of any more than modest claims of modest potential benefits in relation to symptoms of osteoarthritis in the knee. The other material provided by the advertiser was of very limited relevance and persuasive value, and could not generally be described as clinical evidence in relation to the advertised product. It was also unclear, in many instances, whether the evidence material provided by the advertiser could be regarded as directly relevant to the advertised product.

 

14.  In relation to the present complaint, while noting that the complaint and the advertiser’s response were somewhat different to those in the previous complaint, the Panel reached essentially the same conclusion. The Panel was satisfied that the evidence material provided by the advertiser was not of a type or quality that could support strong claims made in advertising to consumers, and that the majority of it was of doubtful or undemonstrated relevance to the advertisement and the complaint. In particular, the material was not capable of supporting claims that the product had been “clinically tested” in a context where claims of therapeutic benefits were made. The Panel also noted that support for the claim that “regular intake over 4-12 weeks results in an improvement of mobility and a reduction in stiffness” appeared to be based on particularly limited evidence.

15.  The Panel was therefore satisfied that the advertisement contained representations that had not been verified, were likely to arouse unwarranted expectations, and were misleading, in breach of sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Code. These included the representations that the advertised product could provide benefits in relation to rheumatoid arthritis or its symptoms or maintain or help maintain healthy cardiovascular function, together with the representations that it was clinically tested or clinically demonstrated to have any therapeutic benefits when taken by ordinary, healthy consumers.

16.  The complaint was therefore justified.

Sanctions

 

17.  The Panel requests Chalmers Dale and Co 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 can provide benefits in relation to rheumatoid arthritis or its symptoms or maintain or help maintain healthy cardiovascular function, or that it has been clinically tested or clinically demonstrated to have any therapeutic benefits when taken by ordinary, healthy consumers, together with the representations that it is offers benefits in relation to arthritis other than modest possible benefits in relation to osteoarthritis symptoms in a context where the provisional and limited nature of the supporting evidence is made clear and explicit;

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.cararthron.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.

18.  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 6 March 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 homepage of the website www.cararthron.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 Cararthron, which we published on this website, should not have been published.

 

 

In the advertisement we unlawfully made claims that Cararthron could have benefits in relation to rheumatoid arthritis and cardiovascular health. We also claimed that Cararthron was clinically tested and had been shown to be effective in relieving arthritis symptoms and aiding joint function.

 

 

A complaint about the advertisement was recently upheld by the Complaints Resolution Panel. The evidence we provided was very limited in relevance and quality, and was not capable of supporting the strong claims we made in the advertisement. At best, the evidence we provided suggested that Cararthron may offer possible modest benefits in relation to osteoarthritis, but that further research is required before such a claim could be made with certainty. The Panel found that the claims in the advertisement were unlawful, misleading, and unverified and breached 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:

180 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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