Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2010-03-022 Rocket Formula

Meeting held 19 August 2010

1.      The complaint concerned a print advertisement published in issue 119 of Wellbeing magazine.

2.      The advertisement included claims related to longevity, energy, stress, the immune system, reducing sugar cravings and energy swings, oxygenating the blood, boosting energy, endurance, memory, nervous system function, increasing blood circulation, and mental alertness.

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

4.      The advertisement promoted the product Purivite Rocket Formula.

5.      The advertiser was Purivite Australia Pty Ltd.

6.      The publisher of the advertisement was Wellbeing Magazine.

7.      The complainant was anonymous.

8.      The complainant requested anonymity.

9.      The complainant alleged that the advertisement breached section 42C of the Act, because it lacked a required approval number.

10.  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:

a)      Possible breaches of sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Code through claims that the advertised product has benefits in relation to longevity, energy, stress, the nervous system, the immune system, sugar cravings, energy swings, endurance, memory, blood circulation, and mental alertness;

b)      A possible breach of section 5(2) of the Code because of a reference to anaemia; and,

c)      Possible breaches of section 6(3) of the Code because mandatory information is not included in the advertisement.

11.  The advertiser stated that the advertisement was a “free editorial” and that they had assumed that approval had been organised by the publisher. The advertiser provided the Panel with some general information related to the product, but did not provide evidence in support of the claims made in the advertisement.

12.  The publisher did not provide a response to the Panel. However, in correspondence provided by the advertiser, the publisher appeared to take a view that the advertisement did not require approval since it was “added value... no charge.”

13.  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, and through reference to the Regulations, applies to “advertisements for designated therapeutic goods published or inserted, or intended to be published or inserted, for valuable consideration, in specified media.” The Panel was satisfied that the advertisement ought to have been approved, but had not been approved. The Panel noted that an advertisement inserted as “added value” pursuant to the publication of a paid advertisement was clearly to be regarded as having been inserted for valuable consideration.  This aspect of the complaint was found justified for both the advertiser and the publisher.

14.  This aspect of the complaint was therefore justified.

15.  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”.

16.  The Panel was satisfied that the advertisement contained representations that breached sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Code, namely the claims that the advertised product has benefits in relation to longevity, energy, stress, the nervous system, the immune system, sugar cravings, energy swings, endurance, memory, blood circulation, and mental alertness. These aspects of the complaint were therefore justified.

17.  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.

18.  The Panel was satisfied that the reference to anaemia in the advertisement caused it to breach section 5(2) of the Code. This aspect of the complaint was therefore justified.

19.  The Panel ought to have included an approval number and contained a reference to the approved/permitted indication(s) for the use of the goods advertised (section 6(3)(b) of the Code), the words “always read the label” (section 6(3)(c) of the Code), and the words “use only as directed” and “if symptoms persist see your doctor/healthcare professional” (section 6(3)(d) of the Code). The advertisement did not include these mandatory statements. These aspects of the complaint were therefore justified.

20.  The Panel requests Purivite Australia Pty Ltd, and Wellbeing Magazine, 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 has benefits in relation to longevity, energy, stress, the nervous system, the immune system, sugar cravings, energy swings, endurance, memory, blood circulation, or mental alertness, together with any representations concerning anaemia;

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; 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.

21.  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 25 October 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).

*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.