Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2010-07-017 Cramps Away

Meeting held 16 December 2010

1.      The complaint concerned a print advertisement published in the August 2010 edition of Health Smart magazine.

2.      The advertisement included words such as “if you suffer from painful cramps, spasms, nagging muscle pain, Restless Legs Syndrome, leg twitches or lower back pain, you know how sore, aggravating, and tormenting it can be”, “there’s a new, strong, herbal and mineral formula which might be exactly what you need”, “you can never be too sure when you’re going to be struck down by cramps”, “Restless Legs Syndrome makes your legs twitch uncontrollably, particularly when you are resting”, “may assist with period pain”, “may help intestinal cramps”, “may also assist with muscle action and muscle weakness if you are vitamin D deficient”, “may assist with wound healing”, “may also assist with pain... it may assist muscle pain and lower back pain... may also assist with joint pain and inflammation, particularly if you suffer from arthritis and rheumatism”.

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

4.      The advertisement promoted Cramps Away.

5.      The advertiser was Totally Natural Products.

6.      The complainant requested anonymity.

7.      The complainant expressed the following concerns about the advertisement:

a)      That the words “if you suffer from painful cramps, spasms, nagging muscle pain, Restless Legs Syndrome, leg twitches or lower back pain, you know how sore, aggravating, and tormenting it can be. Well the good news is there’s a new, strong, herbal and mineral formula which might be exactly what you need” cause the advertisement to breach sections 4(2)(a), 4(2)(d), and 4(2)(g) of the Code;

b)      That the words “an attack of the cramps can occur anytime. But in particular, they can lead to a real rude awakening! All of a sudden, in the middle of the night, you’re awake and in pain...” caused the advertisement to breach section 4(2)(d) of the Code;

c)      That the words “you can never be too sure when you’re going to be struck down by cramps! Pain can occur in your neck, back, legs, knees, arms, elbows, and feet. Whilst Restless Legs Syndrome makes your legs twitch uncontrollably, particularly when you are resting” caused the advertisement to breach section 4(2)(d) of the Code;

d)     That the words “the Australian owned, natural health company, Totally Natural Products, has developed a special, high potency formula, called Cramps Away. This amazing formula is for painful cramps” caused the advertisement to breach sections 4(2)(a) and 4(2)(d) of the Code;

e)      That the words “the special Cramps Away formula may assist with pain” caused the advertisement to breach sections 4(2)(a) and 4(2)(g) of the Code;

f)       That the words “for Restless Legs Syndrome sufferers” breached section 5(2) of the Code.

8.      The complainant also stated that “the actual product packaging appears to have the same advertising breaches as listed above.”

9.      The advertiser argued that “the advert needs to be looked at as a complete entity, as each statement is linked to one another”. The advertiser argued that the “primary headline states the 2 main indicated areas of the product, which are cramps and muscle pain”, and that the “secondary headline broadens the condition and goes into some of the symptoms experienced by the people who suffer from cramps and muscle pain such as pain, spasms, twitches, soreness etc.”

10.  The advertiser argued that all of the claims made in the advertisement were supported by evidence, and provided the Panel with copies of some evidence material. The advertiser argued that cramps are very common and can indeed strike randomly, and cited evidence in support of this.

11.  In relation to the references to Restless Legs Syndrome, the advertiser argued that Restless Legs Syndrome is “not a serious disease or condition”. The advertiser also stated that the advertisement had been approved.

12.  Section 1(3) of the Code states that the Code should be interpreted with an emphasis on the object and the principles of the Code, and the total presentation and context of the advertisement. Section 3(2) of the Code states that the conformity of an advertisement with this Code should be assessed in terms of its probable impact upon the reasonable person to whom the advertisement is directed. In assessing the advertisement, the Panel was mindful not only of the particular words cited by the complainant, but of the entire context of the advertisement and its likely impact on a reasonable consumer.

13.  The Panel found that the advertisement, read in its entirety, conveyed a strong impression that the advertised product was for use in relation to very severe symptoms, particularly pain. The Panel noted the use of words such as “struck down by cramps”, “tormenting”, “all of a sudden, in the middle of the night, you’re awake and in pain”, “the uncontrollable movement you experience in bed at night”, and strong and repeated reference to “pain” and “painful” symptoms. The claims in the advertisement were not confined to moderate therapeutic benefits in relation to mild or moderate symptoms in ordinary, healthy consumers.

14.  Section 4(2)(a) of the Code prohibits representations that are “likely to arouse unwarranted and unrealistic expectations of product effectiveness”. The Panel was satisfied that the advertisement breached section 4(2)(a) of the Code because of the strong and exaggerated nature of the symptoms described in the advertisement, and of the benefits the product could offer in relation to those symptoms. This aspect of the complaint was therefore justified.

15.  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.” 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”.

16.  The complainant alleged that the advertisement breached these two sections of the Code in a number of ways. The Panel did not find that the advertisement did so. These aspects of the complaint were therefore not justified.

17.  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.

18.  The Panel noted that the advertisement did not refer only to “restless legs”, but to “Restless Legs Syndrome”, and that Restless Legs Syndrome was not a condition that could be diagnosed by consumers. Restless Legs Syndrome may be a symptom of several potentially serious disorders. The Panel also noted that the references to Restless Legs Syndrome were made in the context of an advertisement that (as noted above) strongly conveyed that the product was suitable for health concerns and pain of a serious nature.

19.  The Panel was satisfied that the references to Restless Legs Syndrome found in the advertisement breached sections 4(2)(b) and 5(2) of the Code. These aspects of the complaint were therefore justified.

20.  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 Restless Legs Syndrome, or in relation to severe or “tormenting” pain and cramps, including representations that are implied by emphasis or lack of qualifying words;

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.

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, including a recommendation that the inclusion of the goods on the Register be cancelled.

Dated 24 January 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.