Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2010-02-008 Circulation Booster

Meeting held 15 July 2010

* 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 a TV advertisement broadcast on Channel 10 in Brisbane.

2.      The advertisement asks “Do you have cankles?” and shows a pair of legs that swell around the ankle area.  The advertisement contains claims that the Circulation Booster will improve circulation, decrease pain and reduce swelling.

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 Circulation Booster.

The advertiser(s)

5.      The advertiser was High Tech Health Pty Ltd.

The publisher(s)

6.      The publisher of the advertisement was Channel 10 Brisbane.

The complaint

7.      The complainant requested anonymity.

8.      The complainant expressed the following concerns about the advertisement:

a)      The “term cankles has come into popular vocab[sic] and is largely seen as ‘fat ankles’ as the calves and ankles blend together. ... If the calf muscle ... is low in the leg then a more muscular ankle appearance is seen.  We might call these cankles but it’s just the shape of the leg and can’t be changed”.

b)      That “this $400 product professes as a TENS machine to Improve circulation, Decrease pain, and Reduce Cankles”. “This is extremely misleading. TENS has some basis in local pain relief but there is no evidence that it will assist circulation or reduce swelling.”

c)      That “if you have pain in the soles of your feet it MAY assist but this is not stated, and any other pain is unlikely at best to be reduced.”

d)     That “A lay person would assume that if they have large ankles regardless of the cause then this device will help.”

e)      That “It is not backed by research and should not be advertised.”

9.      The Panel considered these aspects of the complaints to be allegations of breaches of 4(1)(b), 4(2)(a) and 4(2)(c)of the Code.

The advertiser’s response to the complaint

10.  The advertiser responded to the Panel by stating that the product is Registered with the TGA as a class IIa medical device with the following intended purpose:  Stimulating the body muscles through nerve points, may help to improve blood circulation, relieve stress, fatigue, aches and pain, provide help with arthritic pains, aid fast recovery from muscular injury and it may help to counteract venous stasis for subjects who are immobile.

11.   The advertiser also supplied the ARTG and EC certificates and five papers to support the claims made within the advertisement.

Findings of the Panel

12.  An advertisement for therapeutic goods is defined in the Act to include “any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.”

13.  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”.

14.  The Panel considered the evidence provided by the advertiser.  The papers collectively concluded that there is some evidence for TENS machines in relation to pain relief, but more investigation is needed, and definitive proof of efficacy and safety requires formal investigation in appropriately designed clinical trials. Although the evidence provided suggested TENS machines were able to provide some pain relief, the Panel did not consider the evidence was conclusive nor did this evidence adequately supported the claims “reduce cankles” “improve circulation” or “decrease pain”.  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 this aspect of the complaint to be justified.

15.  Section 4(2)(d) of the Code prohibits advertisements which “abuse the trust or exploit the lack of knowledge of consumers or contain language which could bring about fear or distress.”  The term “cankles” does not, in all cases, refer to a condition which is able to be treated with TENS therapy.  The Panel noted without making a formal finding that the advertisement was likely to breach this section of the Code as it exploits the lack of knowledge of consumers in relation to the reduction of “cankles”.

Sanctions

16.  The Panel requests High Tech Health, 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 Circulation Booster is able to reduce cankles, improve circulation or decrease pain;

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.

17.  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 22 September 2010

For the Panel

Natalie Goodall

A/g 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).

*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.