COMPLAINTS RESOLUTION PANEL DETERMINATION
Complaint 2009-09-008 Sunlight Saunas
Meeting held 21 January 2010
|
Complaint summary
|
|
Complainant
|
Requested anonymity
|
|
Advertiser
|
Sunlight Saunas Pty Ltd
|
|
Subject matter of complaint
|
Website advertisement
|
|
Type of determination
|
Final
|
|
Sections of the Code, Regulations or Act found to have been breached*
|
Code sections 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c), 4(7), 5, 7(3)
|
|
Sections of the Code, Regulations or Act found not to have been breached*
|
Code section 4(2)(g)
|
|
Sanctions
|
Publication of a retraction
Withdrawal of advertisement
Withdrawal of representations
|
* 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 an internet advertisement published at the website www.sunlightsaunas.com.au.
2. The advertisement covered several pages and included claims such as “infrared sauna technology unlike any other”, “far infrared saunas have been shown to assist in weight loss, pain management, skin purification, detoxification and stress reduction”, “far infrared saunas can also provide relief to patients suffering from arthritis, chronic fatigue syndrome, fibromyalgia, and certain skin conditions”.
3. The advertisement also included a “far infrared hyperthermia clinical study review for weight loss”, and referred to a study titled “repeated thermal therapy improves impaired vascular endothelial function in patients with coronary risk factors”. In this context the advertisement made claims of benefits in relation to “significantly lowered blood pressure”, “significant weight loss”, “significantly lowered blood sugar”, “significantly increased blood flow”, “lowered cholesterol”, “lowered triglycerides”. It stated that “repeated infrared sauna treatment improves impaired blood vessel functions in patients with high blood pressure, diabetes, smoking, and high cholesterol. This suggests a preventive role for sauna use for atherosclerosis”.
4. An excerpt of the advertisement can be viewed in the relevant Appendix to this determination.
5. The advertisement promoted Sunlight sauna products.
6. The advertiser was Sunlight Saunas Pty Ltd.
7. The complainant requested anonymity.
8. The complainant expressed the following concerns about the advertisement:
a) That the claim of “detox” breached section 4(1)(b) of the Code;
b) That the advertisement breached sections 4(2)(a), 4(2)(b), 4(2)(c), and 4(2)(g) of the Code because it raised “unrealistic expectations with respect to health benefits” from the advertised product and could “lead consumers to use the machine instead of taking their medication which can lead to potentially serious health conditions”, and because consumers “are led to believe that the product is backed by science by referring to a study” and are “being misled into believing that the machine is a substitute for real medicine”;
c) That the advertisement breached section 4(7) of the Code because of claims that the advertised product “can contribute to weight loss”;
d) That the advertisement breached section 5 of the Code through references to serious conditions;
e) That the advertisement breached section 7(3) of the Code because of references to weight loss without required balancing information.
The advertiser’s response to the complaint
9. In relation to the “detox” claim, the advertiser referred the Panel to enclosed “information from Dr Kinghardt Ref: Persistant Organic Pollutants in 9/11 World Trade Center”, and to an extract from a “recommended letter to send to health insurance companies”, apparently extracted from a book called Detoxify or Die by Sherry Rogers, which appeared to be designed for consumers to send to insurance companies in order to seek assistance in purchasing saunas.
10. In relation to possible unrealistic expectations with respect to health benefits and the possibility (suggested by the complainant) that consumers could seek to treat medical conditions with the advertised product, the advertiser stated:
Nowhere does Sunlight suggest that the sauna be used instead of taking medication. Quite the opposite – reference wording taken from the Sunlight Saunas website states: “Our far infrared saunas operate with the same efficacy in a medical facility as in your home. As with all professional equipment, you may put yourself at risk if you do not fully understand how to use the sauna. Far infrared saunas creating a cure for or treating any disease is neither implied nor should be inferred. DO NOT attempt to self treat any disease with a far infrared sauna without direct supervision of a certified physician. If you have any health concerns, be certain to consult with your physician before using a far infrared sauna.”
11. The advertiser provided further references and stated “it appears that the complainant does not understand the difference between old hot rocks saunas and far infrared saunas, and the fact that far infrared operates at much lower temperatures as stated in the attached materials”.
12. In relation to the alleged breach of section 4(7) of the Code, the advertiser stated that “every one of [the] testimonials is genuine and the authors can be contacted directly to verify their statements made”, and that “Sunlight Saunas has an abundance of these testimonials which proves that they are typical cases because they are occurring so regularly.” In relation to the references to weight loss in testimonials, the advertiser referred that Panel to an additional piece of reference material entitled “Systems Biology, Toxins, Obesity, and Functional Medicine”.
13. In relation to the alleged breach of section 5 of the Code, and the references to serious conditions such as diabetes and high blood pressure, the advertiser stated that “Sunlight Saunas does not make these claims” but rather “it is simply referencing a clinical study”. The advertiser provided the Panel with a copy of the study cited in the advertisement.
14. In relation to the alleged breach of section 7(3) of the Code, the advertiser stated that they would add the words “Sunlight Saunas may assist with weight loss when used in conjunction with a healthy eating plan and regular exercise.” The advertiser again referred the Panel to reference material provided in response to the complaint.
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.”
16. The evidence provided by the advertiser in relation to the “detox” claim could not plausibly be regarded as supporting general claims for detoxification by far infrared saunas. The “recommended letter” from the Detoxify or Die book clearly did not constitute evidence of any kind. The “information from Dr Kinghardt Ref: Persistant Organic Pollutants in 9/11 World Trade Center” was related to rescue workers who had been exposed to high levels of pollutants during a catastrophic event. Even if this material could be extrapolated to ordinary, healthy consumers (and the advertiser provided no argument as to how it could be so extrapolated), the material itself concluded that “this pilot is limited by its small sample size”.
17. The Panel was therefore satisfied that the “detox” or detoxification claim made in the advertisement had not been verified. This aspect of the complaint was therefore justified.
18. The Panel noted that the next part of the complaint appeared to involve two distinct components. The first was an allegation that the advertisement was misleading and aroused unwarranted expectations in relation to the health or medical benefits of the product in breach of sections 4(2)(a) and 4(2)(c) of the Code. The second was an allegation that the advertisement was likely to cause consumers to believe that the advertised product “is a substitute for real medicine” in breach of section 4(2)(b) of the Code. The Panel decided to deal with these two components of the complaint separately.
19. 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”.
20. The Panel noted the argument of the advertiser that a “disclaimer” included in the advertisement (see paragraph 10 above) meant that the advertisement did not make claims of therapeutic benefits.
21. The Panel considered it necessary to state very clearly that such a disclaimer has no meaningful effect when other aspects of an advertisement make clear and unambiguous claims of therapeutic benefits. The Panel considered it to be very clear that the advertisement made strong therapeutic claims. These included claims of detoxification, and claims related to weight loss, pain management, skin purification, stress reduction, arthritis, chronic fatigue syndrome, fibromyalgia, “certain skin conditions”, impaired vascular endothelial function, coronary risk factors, high blood pressure, blood sugar levels, blood flow, cholesterol levels, triglyceride levels, impaired blood vessel function, diabetes, the effects of smoking, high cholesterol, and atherosclerosis.
22. The Panel was not satisfied that the evidence material provided by the advertiser was adequate to support those claims. The claims therefore caused the advertisement to breach sections 4(2)(a) and 4(2)(b) of the Code. These aspects of the complaint were therefore justified.
23. Section 4(2)(b) of the Code prohibits advertisements that are “likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases”.
24. The Panel noted that it is not necessary for an advertisement to cause consumers to use an advertised product “instead of taking their medication” or that the product is “a substitute for real medicine” (as the complainant appeared to argue) in order for the advertisement to breach section 4(2)(b) of the Code. The Panel did not form a conclusion as to whether consumers were likely to regard the advertised product as a substitute for prescribed medication.
25. Nonetheless, the Panel was satisfied that the advertisement breached section 4(2)(b) of the Code, since the wide range of claims related to serious conditions appeared to the Panel to be very likely to lead consumers to self-diagnose or inappropriately treat those serious conditions. This aspect of the complaint was therefore justified.
26. The Panel noted, again, that the disclaimer described in paragraph 10 above did not alter what the Panel considered to be clear representations of therapeutic benefits made in the advertisement.
27. 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 likely to breach this section of the Code. This aspect of the complaint was therefore not justified.
28. 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.” Testimonials themselves are not ordinarily sufficient evidence of compliance with this section of the Code. Rather, it is normally necessary for independent and rigorously obtained evidence to demonstrate that the kinds of results described in testimonials are normal and typical results that can reasonably be expected to be obtained by typical users of the product.
29. The Panel considered the evidence provided by the advertiser in relation to the claims made in the testimonials. The relevant part of the testimonials appeared to the Panel to be the claims of weight loss benefits from using the sauna product. The evidence provided by the advertiser consisted primarily of a paper which, within the text, was described as “explor[ing] a novel hypothesis that links obesity and toxins”. The paper also stated that “further research is needed”. It was clear that the paper could not be regarded – and was not intended by its author to be regarded – as a sufficient basis for strong advertising claims about weight loss benefits from products such as the advertised product.
30. In any case, the Panel noted that it had not accepted the advertiser’s evidence in relation to detoxification for the advertised product, which meant that the hypothetical “link” between “obesity and toxins” described in the paper could not be regarded as relevant to the advertised sauna product.
31. The Panel was therefore not satisfied that the weight loss claims made in the advertisement, including those in the testimonials were accurate and not misleading, or that weight loss results described in the testimonials could be regarded as typical results.
32. The Panel therefore found this aspect of the complaint to be justified.
33. Section 5(1) of the Code prohibits advertisements that “contain, expressly or by implication, a representation specified in Part 1 of Appendix 6.” The representations specified in Part 1 of Appendix 6 of the Code include representations regarding the treatment, cure, or prevention of certain 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.
34. The Panel noted the advertiser’s argument that “Sunlight Saunas does not make these claims” but rather “it is simply referencing a clinical study”. The Panel considered it clear that the information related to the clinical study also constituted representations about the advertised product. The representations were strong and related to serious conditions including arthritis, chronic fatigue syndrome, fibromyalgia, impaired vascular endothelial function, cardiovascular disease, coronary risk factors, high blood pressure, elevated blood sugar levels, elevated triglyceride levels, impaired blood vessel function, diabetes, the effects of smoking, high cholesterol, and atherosclerosis.
35. The Panel was therefore satisfied that the advertisement breached section 5 of the Code. This aspect of the complaint was justified.
36. 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 Panel considered that the advertisement clearly fell within the ambit of section 7(3). The Panel did not find it to convey the required balance, and therefore found this aspect of the complaint to be justified.
37. The Panel also noted, without making any formal finding, that the advertisement appeared likely to breach section 4(6)(b) of the Code through reference to endorsement by a healthcare professional.
38. The Panel requests Sunlight Saunas Pty Ltd, 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 detoxification, weight loss, pain management, skin purification, stress reduction, arthritis, chronic fatigue syndrome, fibromyalgia, skin conditions, vascular endothelial function, coronary risk factors, high blood pressure, blood sugar levels, blood flow, cholesterol levels, triglyceride levels, impaired blood vessel function, diabetes, the effects of smoking, high cholesterol, or atherosclerosis, including representations carried within testimonials in advertisements;
c) not to use the representations in (b) above in any other advertisement unless Sunlight Therapies 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) to arrange for publication on the website www.sunlightsaunas.com.au of a retraction in the form of, and in accordance with, the conditions set out in the attachment to this determination; and,
f) 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.
39. 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 19 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).
An advertisement is to appear on the website www.sunlightsaunas.com.au at the earliest booking opportunity.
A copy of the retraction advertisement, and the page on which it will be published, is to be provided to the Complaints Resolution Panel for approval before publication.
Back...
