Complaints Register

 

1.      The complaint concerned a print advertisement published in the January-February 2009 edition of Living Now magazine, and an internet advertisement published at the website www.LifeWave.com/bodyinharmony.

2.      The print advertisement was headed “LifeWave Patches” and included claims such as “new breakthrough patch technology that will revolutionise the wellness industry”, “exciting new products”, “like acupuncture without needles”, “appetite control and craving control for weight loss”, “detox, antioxidant boost, anti-aging and skin repair”, “pain relief management for injuries and chronic pain such as arthritis and migraine”, “energy and stamina enhancement and fatigue reduction”, “deep restful sleep”, “safe and natural”, “they work by applying stimulation to acupuncture points and meridians”, “used by Michael Phelps and AFL players”, and “contain a blend of amino acids, water, oxygen, and natural organic compounds.”

3.      The print advertisement also directed consumers to advertising at the website www.LifeWave.com/bodyinharmony, which was also a subject of the complaint.

4.      The website advertisement included a range of information in relation to the advertised patch products, including “research” information which referred to “heart rate variability enhancement through nanotechnology” and many other references to heart rate variability, “increase[ing] glutathione levels in the body”, and many other references to health issues.

5.      An excerpt of the advertisements can be viewed in the relevant Appendix to this determination.

6.      The advertisements promoted a range of LifeWave patches, namely the SP6 patch, Y-Age patch, Icewave patch, Energy Enhancer patch, and Silent Nights patch.

7.      The advertiser was Michael Podolsky.

8.      The complainant was anonymous.

9.      The complainant expressed the following concerns about the advertisements:

a)      That they did not comply with section 7(3) of the Code;

b)      That the references to appetite control, craving control, and weight loss breached sections 4(2)(c) and 4(2)(d) of the Code;

c)      That the claims relating to “detox, antioxidant boost, anti-aging and skin repair” were “not listed on the ARTG” in breach of section 22(5) of the Act, which the Panel interpreted as an allegation of a breach of section 42DL(1)(g) of the Act since the advertised products were presented as devices and not as medicines;

d)      That the references in the print advertisement to “pain relief management for injuries and chronic pain such as arthritis and migraine”, and similar claims in the website advertisement, breached section 4(2)(a) of the Code;

e)      That claims such as “wow 20 seconds my pain was gone” and “90 seconds lower back pain was gone”, in testimonials in relation to the Icewave product, breached section 4(2)(c) of the Code;

f)        That claims the advertised products were “safe and natural” breached section 4(2)(i) of the Code; and,

g)      That references to heart rate variability and increasing glutathione levels breached section 5(1) of the Code. The Panel took this to be an allegation of a breach of section 5(2) of the Code, as section 5(1) of the Code did not appear to be readily applicable.

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)      That, in relation to all of the therapeutic claims within the advertisement, the advertisement could breach sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Code;

b)      That the claims related to AFL players and Michael Phelps could breach section 4(7) of the Code; and,

c)      That the products might not be included on the Register.

11. After preliminary consideration of the complaint, the Panel also formed a preliminary view that the person apparently responsible for the advertisements was Michael Podolsky.

12. The advertiser initially responded as follows:

“In regards to the complaint against my LifeWave advertisement that was in the Living Now magazine, I have passed this on to David Peters who is from UNIORG, which is the representative company of LifeWave in Australia. He will be dealing with this complaint.”

13. David Peters of Uniorg subsequently indicated, after some delay, that the complaint had been forwarded to a US office and that he had not heard back.

14. Uniorg then provided evidence that the advertised products were included on the Register, and stated that the website “is the international LifeWave web site from the USA”.

15. In response to the additional matters raised by the Panel, and to the Panel’s advice that it had formed a preliminary view that the person apparently responsible for the advertisements was Michael Podolsky, the advertiser responded that the advertisement had been placed in good faith, “believing that all that was written in the advertisement was true”, and after having obtained “approval permission from the LifeWave head office in the USA.” The advertiser stated that the information was obtained from the US company’s website.

16. The advertiser stated that the advertised products are in fact on the Register and provided evidence of this.

17. In relation to the references to Michael Phelps and “AFL players”, the advertiser stated that he had “been told by LifeWave staff in Australia who hold training sessions that Michael Phelps has used the patches and that a few of the AFL teams have begun using the patches”. The advertiser also stated that “there are photos on the internet that show Michael Phelps with the patches on his body.”

18. The advertiser stated that he had been unaware of the requirements of section 4(2)(i) of the Code.

19. The advertiser provided a response in relation to the therapeutic claims made in the print advertisement, essentially by referring to testimonials and other material on the US website for the products.

20. Under regulation 42ZCAA of the Regulations, the person apparently responsible for an advertisement is the person who, based on the particulars of a complaint and the assessment of the Panel, appears to be responsible for requesting the publication of the advertisement.

21. It was clear that the person apparently responsible for the print advertisement was Michael Podolsky.

22. In relation to the website advertisement, it was necessary for the Panel to consider whether Michael Podolsky or some other person or entity was the person apparently responsible for its publication.

23. It appeared to the Panel that the website, www.LifeWave.com, was a US website which was structured so that it became a “virtual” website for distributors or sellers of the products being promoted. When the website was accessed using the URL www.LifeWave.com/bodyinharmony, it featured prominently contact details for Simon Podolsky. Other URLs customised the contact details so as to promote different sellers.

24. Therefore, while the website advertisement was clearly, in one sense, the responsibility of the US LifeWave company, to the extent that it was customised by the addition of the /bodyinharmony suffix to the internet URL, and to the extent that this customised version of the website was promoted to Australian consumers, the Panel concluded that it appeared to be the responsibility of Michael Podolsky. In reaching this conclusion, and having regard to the inclusion of the /bodyinharmony version of the URL in the print advertisement, the Panel noted that the customised version of the website clearly promoted products for sale in Australia to Australian consumers.

25. 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 advertised products are in fact included in the Register. The Panel therefore found that this aspect of the complaint was not justified.

26. 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”.

27. The Panel was not satisfied that the material provided by the advertiser constituted even minimally persuasive evidence that the advertised products could have the therapeutic benefits claimed in the advertisements. The Panel therefore found that the claims relating to appetite control, craving control, weight loss, detoxification, antioxidant boost, anti-aging, skin repair, pain relief, relief of pain from injuries, relief of chronic pain, relief of migraines, relief of arthritis, enhancing energy, enhancing stamina, reducing fatigue, and promoting restful sleep, had not been verified, were misleading, and were likely to arouse unwarranted expectations in relation to the products. These aspects of the complaint were therefore justified.

28. Section 4(2)(i) of the Code prohibits representations that the goods advertised are completely safe, harmless, or free of side-effects. The advertisements represented the patches to be “safe” without qualification. This aspect of the complaint was therefore justified.

29. Section 4(2)(d) of the Code prohibits advertisements for therapeutic goods that abuse the trust or exploit the lack of consumers. 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. This section defines “weight management” to include weight loss, measurement reduction, clothing size loss and weight control/maintenance. The complainant raised these sections of the Code in relation to the claims of weight loss, appetite control, and craving control in the print advertisement. The Panel was satisfied that the advertisement did not include the required balance stipulated in section 7(3) of the Code. The Panel also found that, in the absence of adequate evidence from the advertiser to support the claims of weight loss, appetite control, and craving control, these claims also placed the advertiser in breach of section 4(2)(d) of the Code. These aspects of the complaint were therefore justified.

30. Section 4(7) of the Code requires that testimonials included in advertisements for therapeutic goods “must be documented, genuine, not misleading and illustrate typical cases only.” The Panel noted that the references to AFL players and Michael Phelps had not been documented as required by section 4(7) of the Code. The Panel also found that the claims of relief from pain in 20 or 90 seconds made in the website advertisement could not plausibly be regarded as illustrating typical cases only. Further, in the absence of any evidence from the advertiser as to the therapeutic benefits claimed for the products, the testimonials were misleading. These aspects of the complaint were therefore justified.

31. 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” cardiovascular diseases, haematological diseases, infectious diseases, and poisoning. The Panel was satisfied that the many references to “heart rate variability” constituted implied references to serious conditions including cardiovascular disease. This aspect of the complaint was therefore justified.

32. The Panel requests Michael Podolsky, 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 products are safe, or that they have benefits in relation to appetite control, craving control, weight loss, detoxification, antioxidant boost, anti-aging, skin repair, pain relief, relief of pain from injuries, relief of chronic pain, relief of migraines, relief of arthritis, enhancing energy, enhancing stamina, reducing fatigue, or promoting restful sleep;

c)      not to use the representations in (b) above in any other advertisement unless he 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; and,

e)      within 14 days of being notified of this request, to provide evidence to the Panel of his compliance, such as copies of instructions to advertising agents or publishers, or correspondence with retailers and other third party advertisers.

33. 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 May 2009

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).