COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2009-11-021 Stress nomore

Meeting held 18 March 2010

1.      The complaint concerned a print advertisement published in the 15 November 2009 edition of the Sunday Telegraph newspaper.

2.      The advertisement was headed “Are you feeling really, really, STRESSED? If you’re feeling really, really stressed you should read this important health information now.” It made claims of benefits related to physical fatigue, mental fatigue, poor sleep, low sex drive, poor sexual performance, low mood, anxiety, nervous exhaustion, restlessness, memory loss, a lack of concentration, low energy levels, low stamina levels, a “lack of vitality”, mental exhaustion, poor alertness, and a “lack of general wellbeing.” It stated that the advertised product was “a new, strong, adult-strength anti-stress formula specially designed to help keep you relaxed” and that it “might even boost your sex drive”, and described it as “a strong, high potency anti-stress and libido boosting formula.”

3.      It made reference to stress where “a person feels they just can’t cope”. Other words used in the advertisement included “withania is a nerve sedative”, “polygala may act as a sedative and assist with anxiety and restlessness”, “polygala and Panax ginseng may also help you sleep better”, “because a deficiency in Tyrosine may lead to stress exhaustion, it has been included”, “tyrosine may assist with stress and anxiety”, “less stress, more SEX... or even, more SEX, less stress!”, “while stress can cause a low libido, having sex can be a great stress reliever. That is why Panax Ginseng, Withania, and Tyrosine are in Stress nomore”, “as an aphrodisiac Panax ginseng has a stimulating effect on sex hormones and may help improve your sex drive”, “Panax Ginseng may help increase an overall improvement in your physical and sexual performance”, “withania is excellent for sex as it acts as a tonic and may enhance your sex drive”, “tyrosine may assist with low sex drive”, “vitamin D, Polygala and Tyrosine have all been added for low mood”, “vitamin D may help improve your mood”, “if you’re broody or constrained emotionally, Polygala may be just what you need”, “tyrosine may assist with low mood”, “Panax ginseng may help increase your memory and concentration”, “polygala may help benefit mental function”, “withania may assist with memory loss”, “tyrosine may improve your memory and concentration and increase your alertness”, and “tyrosine may also assist with brain fatigue, mental exhaustion, and mental endurance”.

4.      The advertisement represented the advertised product to have been “scientifically formulated” by “the researchers at the Australian owned, natural health company Totally Natural Products”.

5.      The advertisement also included a product image which carried words such as “stress and anxiety”, “poor sex drive”, “mood”, “fatigue”, “stamina and energy”, “memory and concentration”, “immunity and general wellbeing”, and “scientifically formulated.”

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

7.      The advertisement promoted the product Stress nomore.

8.      The advertiser was Totally Natural Products.

9.      The complainant was anonymous.

10.  The complainant alleged that the advertisement breached sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Code because of a lack of “proof of many of its claims”. The complainant also listed many of the claims in the advertisement and stated “please see the full advertisement”.

11.  The complainant also alleged that the advertisement breached section 4(2)(b) of the Code.

12.  The advertiser stated that they “completely disagree” with the complaint, and provided a copy of an “evidence table”, which contained summaries (prepared by the advertiser) of a range of evidence material said to support the claims made in the advertisement. The advertiser also provided full copies of some evidence material.

13.  The advertiser also expressed disagreement with the alleged breach of section 4(2)(b) of the Code, arguing that “no disease state is mentioned at any point in the advertisement” and that “therefore no self diagnosis is possible where the disease does not exist.”

14.  The Panel reviewed the material before it, giving lengthy consideration to the evidence material provided by the advertiser. The Panel made a number of observations relating to the evidence, including that:

a)      the material said to support the claims related to increasing resistance to stress, countering the effects of stress, and allowing the body to adapt to stress more effectively involved doses of ingredients that were very substantially higher than those found in the advertised product, and therefore could not be regarded as supporting the claims made in the advertisement;

b)      the material said to support the claim related to “stimulating effects on sex hormones” involved 1 to 9g of the ginseng ingredient daily, while the advertised product contains only 135mg of the ginseng ingredient;

c)      the material related to tyrosine, said to support claims related to both mood and various mental performance claims, included doses at levels such as 100mg per kg of subject body mass, while the advertised product contained only 500mg of tyrosine;

d)     the material related to sexual performance generally related to men with conditions  such as erectile dysfunction, and not to healthy men and women generally, and in any case involved doses of ingredients that were not comparable to doses found in the advertised product;

e)      some of the material appeared to relate to traditional use of the ingredients in the product, and could not be relied upon to support claims in the advertisement (other than a small number of claims which were explicitly stated to relate to traditional use), as the advertisement clearly represented the product to have been “scientifically formulated”;

f)       some of the material could be regarded as, at best, preliminary research in relation to the ingredients and their benefits, and not as evidence to support claims in advertising; and,

g)      some evidence related to serious conditions such as depression, addictive substance withdrawal, and erectile dysfunction, and no evidence was advanced by the advertiser that such evidence could be extrapolated to normal, healthy individuals to whom the advertisement was directed.

15.  The foregoing summary of the Panel’s concerns relating to the evidence provided should be regarded only as indicative of the kinds of concerns held by the Panel, and not as an exhaustive list of the Panel’s concerns.

16.  The Panel also noted that, although the advertiser had explicitly responded in relation only to those claims quoted by the complainant, it was clear that the complainant had directed the complaint towards all claims in the advertisement.

17.  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”.

18.  Given that the evidence provided by the advertiser could not be regarded as adequate to support the claims made in the advertisement, the Panel was satisfied that the claims relating to resistance to stress, countering the effects of stress, allowing the body to adapt to stress more effectively, having a stimulating effect on sex hormones, improving mood, or having benefits in relation to energy levels, fatigue, endurance, performance, memory, concentration, alertness, brain fatigue, mental exhaustion, mental endurance, sex drive, sexual performance, sedative effects, “powerful anti-stress and anti-anxiety” effects, aphrodisiac effects, enhancing sex drive, and memory loss had not been verified, were likely to arouse unwarranted and unrealistic expectations in relation to the product, and were misleading, in breach of sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Code.

19.  The Panel also found that the words “stress nomore” implied that the advertised product would eliminate stress or the effects of stress, and that such implied representations had not been verified, were likely to arouse unwarranted and unrealistic expectations in relation to the product, and were misleading, in breach of sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Code.

20.  These aspects of the complaint were therefore justified.

21.  Section 4(2)(b) of the Code prohibits advertisements that are “likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases”. The advertiser was satisfied that the overwhelming emphasis of the advertisement on very high levels of stress and anxiety with which consumers “just can’t cope”, together with an overwhelming emphasis on sexual function and sex hormones, were likely to lead to consumers inappropriately treating potentially serious diseases such as depression and sexual dysfunction. This aspect of the complaint was therefore justified.

22.  The Panel requests Totally Natural Products, 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 resistance to stress, countering the effects of stress, adaptation to stress, stimulation of sex hormones, improving mood, energy levels, fatigue, endurance, performance, memory, concentration, alertness, brain fatigue, mental exhaustion, mental endurance, sex drive, sexual performance, sedative effects, “powerful anti-stress and anti-anxiety” effects, aphrodisiac effects, enhancing sex drive, or memory loss, together with the representations regarding stress conveyed by the words “stress nomore” or “stress no more”;

c)      not to use the representations in (b) above in any other advertisement unless Totally Natural Products 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, in each publication where the advertisement was printed, 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.

23.  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 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).

An advertisement is to appear in all publications where the advertisement carrying approval number CHC51070-10/09 was published, at the earliest booking opportunity.

A copy of the retraction advertisement, and the pages on which it will be published, is to be provided to the Complaints Resolution Panel for approval before publication.

No other copy should be included in the advertisement.

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