COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2009-12-016 Cara-Thin

Meeting held 15 April 2010

1.      The complaint concerned internet advertisements published at the websites www.contourwrap.com.au, www.surgeryfree.com.au, and www.bodypatch.com.au.

2.      The advertisements were essentially identical and included claims such as “absolutely incredible”, “will reduce your hunger, burn fat, increase metabolism, and assist with weight loss and slimming all in an easy to take capsule”, “results are fast with many clients reporting effects almost immediately”, “this all helps with weight reduction and inches loss”, “so unique and effective”, “appetite suppressing qualities of Caralluma Fimbriata are believed to stem from its effect on the lateral hypothalamus (the appetite control mechanism of the brain)”, “thermogenic fat burning properties come from its ability to block the activity of several enzymes which then block the formation of fat in the body forcing fat reserves to be burned”, “promotes the loss of abdominal fat”, and “fucoxanthin is the first marine algae-derived ingredient with clinically proven thermogenic effect”.

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

4.      The advertisements promoted the product Cara-Thin.

5.      The advertiser was Excellence Group.

6.      The complainant requested anonymity.

7.      The complainant alleged that the advertisements breached section 42C of the Act and sections 4(2)(a), 4(2)(c), 4(2)(g), 4(2)(h), and 7 of the Code. The complainant also stated that the advertised product “does not have an AUST L listing number”, which the Panel took to be an allegation of a breach of section 42DL(1)(g) of the Act.

8.      The advertiser stated that the product “is only advertised as a ‘Supplement’ as it should only be used as a supplement to healthy eating (not fast or fried foods) and accompanied with moderate exercise to assist with weight loss”, and that “it is not marketed as a stand-alone ‘Weight Loss Pill’ where the pill is the only thing required for weight loss”.

9.      The advertiser stated that “it is well known and proven empirically in clinical trials that [the Caralluma fimbriata] ingredient is very effective at reducing hunger, increasing metabolism which in itself helps to reduce weight.” The advertiser also stated that “our products do work and we believe the greatest proof of this is in customers coming back to purchase more and more... after all, you would not come back and purchase more of a product that did not work, right!”.

10.  The advertiser emphasised that the advertised product was normally sold along with other products rather than alone.

11.  The advertiser provided the Panel with website addresses related to the Caralluma fimbriata ingredient, which were presented as evidence for the claims made in the advertisements.

12.  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.

13.  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, and that therefore any of the material in the advertisement that presented the product as being for therapeutic use (as defined in the Act) would be sufficient to render the material in breach of section 42DL(1)(g). The advertisement clearly contained many therapeutic claims which ought not to have been made, and therefore breached section 42DL(1)(g) of the Act. The Panel therefore found this aspect of the complaint justified.

14.  Section 42C of the Act makes it an offence to publish certain advertisements for therapeutic goods in specified media that does not have an approval number, or to publish an advertisement without its approval number. It does not apply to advertisements for therapeutic goods that are not on the Register (such advertisements generally breach section 42DL(1)(g) of the Act). This aspect of the complaint was therefore not justified.

15.  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”.

16.  The Panel reviewed the evidence material provided by the advertiser. It included material published on sites promoting similar products, or prepared by the manufacturer of the Caralluma fimbriata ingredient, in some cases purporting to summarise a number of small clinical studies that did not appear to have peer-reviewed or published. One study involving 50 subjects in India appeared to have been published.

17.  The Panel did not find the evidence provided by the advertiser to be of sufficient scope or quality to support the claims made in the advertisements, or to constitute more than  preliminary or suggestive evidence for such claims. The Panel was therefore satisfied that the representations that the advertised product could reduce hunger, burn fat, increase metabolism, assist with weight loss, assist with slimming, provide rapid or almost immediate results, help with weight reduction, help with measurement loss, suppress appetite, have an effect on the lateral hypothalamus, have “thermogenic” or “fat-burning” properties, block the activity of enzymes, block the formation of fat in the body, force fat reserves to be burned, or promote the loss of abdominal fat, were representations that had not been verified, and were misleading and likely to arouse unwarranted expectations in relation to the advertised product. These aspects of the complaint were therefore justified.

18.  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”.

19.  Noting the use of expressions such as “absolutely incredible”, “many clients reporting effects almost immediately”, “so unique and effective”, and “it is widely believed that Caralluma fimbriata will surpass Hoodia as everyone’s favorite suppressant”, together with an emphasis on the advertised product being “powerful” and “extremely effective”, the Panel was satisfied that the advertisements breached sections 4(2)(g) and 4(2)(h) of the Code. These aspects of the complaint were therefore justified.

20.  Section 7(3) of the Code requires that advertisements making weight management claims must have an appropriate balance between those claims and references to healthy energy-controlled diet and physical activity. This section defines “weight management” to include weight loss, measurement reduction, clothing size loss and weight control/maintenance. The advertisements clearly fell within the ambit of section 7(3), and contained essentially no balancing information regarding diet and physical activity. The Panel therefore found this aspect of the complaint to be justified.

21.  The Panel noted, without making any formal finding, that the advertisement appeared likely to breach section 6(3) of the Code in that it did not include required statements.

22.  The Panel requests Excellence Group, in accordance with subregulation 42ZCAI(1) of the Therapeutic Goods Regulations 1990:

a)      to withdraw the advertisements from further publication;

b)      to withdraw any representations that representations that the advertised product can reduce hunger, burn fat, increase metabolism, assist with weight loss, assist with slimming, provide rapid or almost immediate results, help with weight reduction, help with measurement loss, suppress appetite, have an effect on the lateral hypothalamus, have “thermogenic” or “fat-burning” properties, block the activity of enzymes, block the formation of fat in the body, force fat reserves to be burned, or promote the loss of abdominal fat, together with any other representations that the advertised product is for therapeutic use;

c)      not to use the representations in (b) above in any other advertisement unless Excellence Group 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 websites www.contourwrap.com.au, www.surgeryfree.com.au, and www.bodypatch.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.

23.  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 31 May 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 websites www.contourwrap.com.au, www.surgeryfree.com.au, and www.bodypatch.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.

No other copy should be included in the advertisement.

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