Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2009-11-008 Fatzapper Advertisements

Meeting held 4 February 2010

1.      The complaint concerned internet advertisements published at the websites www.johnson-barana.com.au, www.thexton.com.au, and www.vitaminking.com.au.

2.      The advertisements differed in some ways but generally shared claims such as “scientifically proven”, “scientifically formulated to absorb fat from your diet”, “it allows you to enjoy your favourite foods without the undesirable downside of weight gain”, “the incredible fat reduction effects of chitosan are backed by extensive scientific researches”, “helps you lose weight by blocking fat digestion and converting extra body fat into energy and muscle”, “with choline, FatZapper increases metabolising activities, resulting in leaner body, firmer and younger skin tones”.

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

4.      The advertisement promoted the product FatZapper.

5.      The advertisers were Johnson and Barana Co Pty Ltd (the product sponsor), ThextonHealth (a retailer), and Vitamin King (a retailer).

6.      The complainant was Dr Ken Harvey.

7.      The complainant alleged that the advertisement breached section 42DM(1) of the Act and sections 4(1)(b), 4(2)(a), 4(2)(c), and 7(3) of the Code.

8.      The complainant highlighted various words in each of the advertisements.

9.      Vitamin King stated that product advertisements on their website were based on promotional material “sourced from the product’s company such as from the company’s website, catalogues, manuals, and/or from the product label itself [and] in the case of Fat Zapper, [they] based it on the company’s website.” Vitamin King stated that they would “remain neutral” until the Panel reached a decision based upon the response provided by Johnson and Barana, the product sponsor.

10.  ThextonHealth stated that they “only replicate information that has been provided to us” and that “if material displayed on [their] website becomes out of date or changes, once notified of any change by any supplier these are quickly and efficiently removed/changed.”

11.  Johnson and Barana stated that “most of the complaint stemmed from one old brochure, scanned and presented on “the ThextonHealth website” which had “ceased circulation for more than two years.”

12.  In relation to the claims related to fat absorption, Johnson and Barana stated that “the complainant made a negatively biased presentation on the clinical studies”. Johnson and Barana provided “a copy of an extensive scientific review article” and stated that “it is a fact that chitosan for fat trapping/weight control is well studied and well supported by human clinical trials, animal studies, and laboratory experiments.”

13.  Johnson and Barana provide further supporting material in relation to these claims.

14.  Where an advertiser publishes information regarding a product in an advertisement, it is a prima facie presumption that the advertiser is the person responsible for publishing that information even where it has been copied from material published by the product sponsor. Material that has been compiled from sources such as product packaging, sponsor websites, or other material may not be current, may not have been provided with the intention that it be reproduced in advertising by others, or may in some other way be deficient. Such material may have been reproduced without the consent, control, or authorisation of the product sponsor.

15.  If, therefore, the product sponsor or some other party is to be considered responsible for the information contained in the advertisement, rather than the advertiser, it would (at a minimum) be necessary for the advertiser to provide documentary evidence that the information was provided to the advertiser expressly for the purpose of advertising the product. This is not to say that retailers must hold evidence in the same way that product sponsors must. It is simply to say that if a retailer is in the business of advertising and selling therapeutic goods, it is not unreasonable to expect that retailer to take on the responsibility, at a minimum, of instituting a process whereby the accuracy of advertising claims is explicitly warranted by the product sponsor, and this warranty is documented.

16.  Since no such documentary evidence was provided by either ThextonHealth or Vitamin King, the Panel considered those retailers to be the persons responsible for publication of the advertisements on their respective websites.

17.  As ThextonHealth and Vitamin King provided no substantive response to the complaint, the Panel took the response from Johnson and Barana, the product sponsor, to be the relevant response in relation to the complaint as it concerned each of the three website advertisements.

18.  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”.

19.  The Panel considered the evidence provided by the advertiser. The Panel was satisfied that some very modest and preliminary evidence could be said to support a claim that the chitosan ingredient could reduce fat absorption, or could aid weight loss. The Panel noted that the review material provided by the advertiser also included data suggesting that the chitosan ingredient had no such benefits at all. On balance, it was clear that the evidence relating to the chitosan ingredient could at best be described as modest and limited.

20.  The Panel also noted that although Johnson and Barana provided a table showing some information in relation to other ingredients in the product, they did not provide actual copies of any evidence material in relation to those ingredients.

21.  On this basis the Panel was not at all satisfied that the advertised benefits could be said to have been “scientifically proven”,  “scientifically formulated to absorb fat from [the] diet”, or “backed by extensive scientific research”. In the Panel’s view, the claims that the product “allows you to enjoy your favorite foods without the undesirable downside of weight gain”, that it has “incredible fat reduction effects”, “helps you lose weight by blocking fat digestion and converting extra body fat into energy and muscle”, or “increases metabolising activities, resulting in leaner body, firmer and younger skin tones” were strong and unequivocal claims that were not at all adequately supported by the evidence provided, and generally involved a degree of extrapolation that was not justified.

22.  Representations in advertisements must be made in a way, and in a context, that accurately reflects the evidence underlying them. It appeared to the Panel that the representations relating to fat absorption and weight loss would only be acceptable if made in a context that was appropriately clear about the level, type, and quality of evidence available to support the claims – that is, that the evidence was limited and generally preliminary, and could not be regarded as conclusive or strong.

23.  All of the advertisements therefore breached sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Code, and these aspects of the complaint were justified.

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

25.  Section 42DM(1) of the Act requires that advertisements comply with the Code. Given the foregoing findings of the Panel, this aspect of the complaint was obviously justified.

26.  The Panel noted, without making any formal finding, that the brochure advertisement on the ThextonHealth website appeared likely to breach section 4(4) of the Code, that all three of the advertisements appeared likely to breach section 6(3) of the Code and that there was a likely breach of section 22(5) of the Act precluding claims for weight loss. 

27.  The Panel requests Johnson and Barana Co Pty Ltd, ThextonHealth, and Vitamin King, 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 the advertised product is scientifically proven,  scientifically formulated to absorb fat from [the] diet, backed by extensive scientific research, can prevent weight gain, has “incredible fat reduction effects”, “block[s] fat digestion and convert[s] extra body fat into energy and muscle”, or “increases metabolising activities, resulting in leaner body, firmer and younger skin tones”;

c)      not to use the representations in (b) above in any other advertisement unless Johnson and Barana Co Pty Ltd, ThextonHealth, and Vitamin King satisfy 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.

28.  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 19 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).