Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2009-12-006 HC-LTU Laser Therapy

Meeting held 18 March 2010

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

2.      The advertisement included claims related to recovery and relief of pain, inflammation, discomfort, and swelling, and stated that the advertised product was “TGA registered... [and] suitable for a patient to use at home without medical supervision.”

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

4.      The advertisement promoted the HC-LTU Laser Therapy Unit device.

5.      The advertiser was Poppy Lane Skin Care and Lymphoedema Clinic.

6.      The complainant was anonymous.

7.      The complainant alleged that the advertisement breached sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(g), and 4(6) of the Code.

8.      The Panel noted that the complainant made reference to section 4(6)(a) of the Code, but appeared (because of words used in the complaint) to have intended to allege that the advertisement breached section 4(6)(b)(i) of the Code. The Panel noted that the advertiser also appeared to have understood the complaint to relate to this aspect of the Code.

9.      The advertiser expressed dismay in relation to the complaint, and stated that in response to the complaint they “immediately... rectified the information contained in web pages to be in accordance with” the Code.

10.  The advertiser stated that the claims made in the advertisement had been derived from documents found on the website of the overseas product manufacturer. The advertiser provided copies of various documents in support of the claims made.

11.  In relation to the alleged breach of section 4(6)(b) of the Code, the advertiser stated that reference to the TGA had been intended to “negate a negative and constant inference by a competitor to potential clients that the [advertised product] was not included in the” Register.

12.  The advertiser also provided copies of “revised web pages”.

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 reviewed the evidence material provided by the advertiser, which included a full copy of one published article and a number of summaries and abstracts of research material. The Panel found that the advertiser had not provided any indication as to how the advertised product could be related to the evidence material, particularly in relation to the intensity and frequency or wavelength of the light emitted by the device. The Panel noted that evidence of benefits from “low level laser therapy” as a general category cannot necessarily be regarded as evidence for a particular device, and that many of the abstracts provided by the advertiser appeared to relate to light frequencies than differed from those emitted by the advertised product.

15.  The Panel was therefore satisfied, on the basis of the material before it, that the representations relating to recovery and relief of pain, inflammation, discomfort, and swelling, or reducing the need for analgesic and anti-inflammatory medication, included in the advertisement had not been verified, were misleading, and were likely to arouse unwarranted expectations in relation to the advertised product. These aspects of the complaint were therefore justified.

16.  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”. The Panel did not find words in the advertisement that appeared to convey such a representation, and the complainant did not direct the Panel to such words. The Panel therefore found that this aspect of the complaint was not justified.

17.  Section 4(6)(b) of the Code prohibits representations that goods are endorsed by government bodies. While in one sense words referring to the TGA, 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. This aspect of the complaint was therefore justified.

18.  The Panel’s role is to give consideration to complaints regarding advertisements that have been published. It is not the Panel’s role to consider whether proposed new wording for advertisements complies with the Code, Regulations, and Act. Accordingly, the Panel did not give consideration to the wording of the “revised web pages” provided by the advertiser.

19.  The Panel noted, without making any formal finding, that the testimonial appeared to breach section 4(6)(b)(ii) (healthcare professional recommendation) and section 4(7) (testimonials) of the Code.

20.  The Panel requests Poppy Lane Skin Care and Lymphoedema Clinic, 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 relating to recovery and relief of pain, inflammation, discomfort, and swelling, or reducing the need for analgesic and anti-inflammatory medication, or that it is endorsed by any government agency;

c)      not to use the representations in (b) above in any other advertisement unless Poppy Lane Skin Care and Lymphoedema Clinic 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;

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.

Dated 29 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).