Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2011-02-004 Mora Device

Meeting held 17 March 2011

1.      The complaint concerned an internet advertisement published at the website www.naturaltherapypages.com.au.

2.      The advertisement made claims of benefits relating to acne, “nutritional energy balancing”, asthma, hayfever, cold sores, cystitis, candida, arthritis, digestive complaints, menstrual complaints, sinusitis, shingles, flu, headaches, and migraines. It also referred to bacteria, viruses, and parasites.

3.      The advertisement also stated that the advertised device could “give a clear understanding of allergens and make up homeopathic remedies that will help you to overcome the allergic response you are experiencing”.

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

5.      The advertisement promoted a “Mora device”, the “Mora III RM 200”.

6.      The advertiser was Christine Dunning.

7.      The publisher of the advertisement was Natural Therapy Pages.

8.      The complainant requested anonymity.

9.      The complainant alleged that the advertisement breached section 42DL(1)(g) of the Act, and sections 4(2)(a), 4(2)(b), 4(2)(c), 4(2)(d), 4(2)(h), and 5 of the Code.

10.  The complainant also alleged that the advertisement breached section 22(5) of the Act. The Panel gave no consideration to this aspect of the complaint as the section does not apply to goods that are not included in the Register.

11.  Through legal counsel, the advertiser stated that the material in question had been removed from the website in response to the complaint. The advertiser stated that the advertised product is manufactured and supplied by a reputable company, and that she had not been aware that the device was required to be included in the Register. The advertiser stated that the Australian agent for the advertised product is Steve McKeown, and that she had been of the understanding that Mr McKeown would attend to the inclusion of the device on the Register.

12.  The advertiser also provided some evidence material in relation to the advertised products.

13.  The advertiser argued that the advertisement, in stating that the listed ailments had “responded” to the advertised product, did not recommend the product for particular conditions.

14.  As a preliminary matter, the Panel found that the references in the advertisement to “conditions which have responded” to the advertised device constituted claims that the advertised device was therapeutically effective in relation to those conditions. Moreover, the advertisement clearly represented the advertised device as being for use in the diagnosis of allergies.

15.  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.

16.  Section 42DL(1)(g) of the Act prohibits the publication of advertisements for therapeutic goods that are not included in the Register. The Panel was satisfied that the advertisement represented the advertised product as being for therapeutic use, and therefore brought it within the definition of therapeutic goods found in the Act.  The advertised product is not included in the Register, and the advertisement therefore breached section 42DL(1)(g) of the Act. The Panel therefore found this aspect of the complaint justified.

17.  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”.

18.  The Panel reviewed the evidence material provided by the advertiser. The Panel was not satisfied that the material was of sufficient scope or quality to support advertising claims about therapeutic effects of the advertised product. The Panel was satisfied that the advertisement breached sections 4(2)(a) and 4(2)(c) of the Code because of the representations that the advertised product could have benefits or therapeutic effects in relation to acne, “nutritional energy balancing”, asthma, hayfever, cold sores, cystitis, candida, arthritis, digestive complaints, menstrual complaints, sinusitis, shingles, flu, headaches, migraines, bacteria, viruses, or parasites, or that it could aid in the diagnosis of allergies or the formulation of allergy remedies. These aspects of the complaint were therefore justified.

19.  Section 4(2)(b) of the Code prohibits advertisements that are “likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases”. 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.

20.  The advertisement made unqualified reference to serious conditions such as asthma and shingles, and bacterial, viral, and parasitic infections. The Panel was satisfied that the advertisement was likely to lead consumers into inappropriately treating potentially serious diseases. The advertisement therefore breached sections 4(2)(b) and 5(2) of the Code. This aspect of the complaint was therefore justified.

21.  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 complainant alleged that the advertisement breached this section of the Code “because consumers do not understand what an electromagnetic frequency device is”. The Panel did not find the advertisement to breach the Code in this way. This aspect of the complaint was therefore not justified.

22.  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”. Section 4(2)(j) of the Code prohibits advertisements for therapeutic goods that target children. The Panel did not find words in the advertisement that appeared to breach these sections of the Code. These aspects of the complaint were therefore not justified.

23.  The Panel requests Christine Dunning, 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 can have benefits or therapeutic effects in relation to acne, “nutritional energy balancing”, asthma, hayfever, cold sores, cystitis, candida, arthritis, digestive complaints, menstrual complaints, sinusitis, shingles, flu, headaches, migraines, bacteria, viruses, or parasites, or that it can aid in the diagnosis of allergies or the formulation of allergy remedies, 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*;

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.

24.  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  25 March 2011

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.