Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2010-01-006 Ahmaya

Meeting held 15 April 2010

1.      The complaint concerned a print advertisement published in the 3 January 2010 edition of the Sunday Telegraph newspaper.

2.      The advertisement was headed “immediate fat loss now without surgery!” and included claims such as “TGA approved”, “permanent fat loss in just 15 mins”, “quick and easy”, “average permanent 3cm loss per area treated”, “proud to be first in Australia to use the Cavitation technique devised by Italian Plastic Surgeon Dr Salvatore Sandura”, “exciting new medical device blasts and remove stubborn fat from selected body areas”, “reduction immediately visible and measurable”, “produces skin tightness and excellent tone, clearly evident after each treatment”, “excellent for cellulite reduction”, “simply amazing”, “simply wow”, “no downtime”, “painless”, “no side effects”, “affordable”, and “comfortable treatment”.

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

4.      The advertisement promoted the product a Class IIB medical device.

5.      The advertiser was Ahmaya Pty Ltd.

6.      The complainant requested anonymity.

7.      The complainant alleged that the advertisement breached sections 4(1)(a), 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c), 4(2)(f), 4(2)(g), 4(2)(h), 4(2)(i), and 7(3) of the Code.

8.      The complainant also highlighted the use of the words “TGA approved” in the advertisement, which the Panel took to allege a breach of section 4(6)(b) of the Code.

9.      The advertiser expressed regret in relation to any breaches that may have occurred, and provided documentary material in response to the complaint.

10.  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”.

11.  The evidence material provided by the advertiser did not, in the Panel’s view, support the claims made in the advertisement related to fat reduction, measurement reduction, “blasting” or removing “stubborn fat”, reducing cellulite, or other such claims. The evidence material included testimonials from customers of the advertiser, together with material that appeared to have been provided to the advertiser by the product sponsor. The Panel did not find that the material was persuasive or authoritative, and noted that it did not include full copies of any published studies or similar evidence.

12.  The Panel considered that the advertisement was in breach of sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Code, and found these aspects of the complaint to be justified.

13.  Section 4(2)(b) of the Code prohibits advertisements that are “likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases”. The Panel did not find words in the advertisement that appeared likely to breach this section of the Code. This aspect of the complaint was therefore not justified.

14.  Section 4(2)(f) of the Code prohibits representations that “encourage inappropriate or excessive use” of therapeutic goods. The Panel did not find words in the advertisement that appeared likely to breach this section of the Code. This aspect of the complaint was therefore not justified.

15.  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”. The Panel was satisfied that the advertisement breached these sections of the Code. These aspects of the complaint were therefore justified.

16.  Section 4(2)(i) of the Code prohibits representations that the goods advertised are completely safe, harmless, or free of side-effects. The Panel noted that the advertisement explicitly represented the device to be painless and free of side-effects without qualification. This aspect of the complaint was therefore justified.

17.  Section 4(6)(b) of the Code prohibits representations that goods are endorsed by government bodies. While in one sense words such as those used in the advertisement may constitute an attempt to indicate compliance with the Act, they are likely to convey an implication that the goods so listed are approved by an Australian government agency to a degree that is not factually correct, particularly as regards the efficacy of the product. The complaint was therefore justified.

18.  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 advertisement clearly fell within the ambit of section 7(3). The Panel did not consider that the material conveyed the required balance, and therefore found this aspect of the complaint to be justified.

19.  Section 4(1)(a) of the Code requires advertisements for therapeutic goods to comply with the statute and common law of the Commonwealth, States and Territories. Because of the breaches of the Code already noted, this aspect of the complaint was justified.

20.  The Panel also noted, without making any formal finding, that the advertisement appeared likely to breach section 4(6)(b) of the Code through reference to a healthcare professional, Dr Salvatore Scandura.

21.  The Panel requests Ahmaya 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 is safe or free of side effects, that it is endorsed by any government agency, or that it has benefits in relation to fat reduction, cellulite reduction, causing fat loss, immediate fat loss, or permanent fat loss, causing measurement loss or permanent measurement loss, removing stubborn fat, treating excess fat, improving “scarring post-liposuction”, or improving excess fat bulges;

c)      not to use the representations in (b) above in any other advertisement unless Ahmaya 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; and,

e)      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.

22.  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).