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  Friday 25 April 2014
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Date of Meeting: 02/02/12
Code: 2011/10/027
Product: Kids Smart Products
Complainant: Anonymous
Respondent: PharmaCare Laboratories Pty Ltd
Finding: Justified
Sections Found Justified: Code sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d), 4(2)(f)
Sections Found Not Justified: None
Action: Publication of retraction, Withdraw advertisement; withdraw representations
Panel Determination:
COMPLAINTS RESOLUTION PANEL DETERMINATION
Complaint 2011-10-027 Kids Smart Products
Meeting held 2 February 2012
 

Complaint summary
Complainant
Anonymous
Advertiser
Pharmacare Laboratories Pty Ltd
Subject matter of complaint
Print 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)(c), 4(2)(d), 4(2)(f)
Sections of the Code, Regulations or Act found not to have been breached*
None
Sanctions
 
Withdrawal of representations
Withdrawal of advertisement
Publication of a retraction

 
 
 
 
 
 
 
 
* 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 a print advertisement published in the October 2011 edition of Australian Women’s Weekly magazine.
2.      The advertisement was headed “when your child is overexcited, Kids Smart Calm can help settle them down”, and included claims such as “we know overexcitement, periods of restlessness, and not wanting to do things mum asks are a normal part of growing up. But if settling down is a battle in your home, or your child gets easily overexcited, then Kids Smart Natural Medicine may help”, “an all natural, homeopathic medicine especially formulated to help soothe, relax, and calm over-excited children anytime of day or before bedtime to help promote restful sleep”, “can also help calm children for air or car travel”, and “the range also includes natural homeopathic remedies specifically formulated to help relieve cold and flu symptoms, temporarily soothe mild pain and fever, and relieve runny nose and hayfever.”
3.      An excerpt of the advertisement can be viewed in the relevant Appendix to this determination.
The product(s)
4.      The advertisement promoted the product Kids Smart Calm, Kids Smart Cold & Flu, Kids Smart Pain & Fever, and Kids Smart Runny Nose & Hayfever.
The advertiser(s)
5.      The advertiser was Pharmacare Laboratories Pty Ltd.
The complaint
6.      The complainant was anonymous.
7.      The complainant expressed concern that “to show two perfectly healthy, active little girls and to imply that they need artificial ‘calming’ is worrying”, and asked whether “they have any evidence for their claims”.
8.      The Panel was satisfied that the words of the complaint could be taken to raise possible breaches of sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d), and 4(2)(f) of the Code.
The advertiser’s response to the complaint
9.      The advertiser argued that “the advertisement is very balanced” and was intentionally directed at parents of “perfectly healthy, active” children.
10. The advertiser stated that the advertised Kids Smart Calm product “is a homeopathic preparation and is potentised (succussed) and diluted to a factor more dilute than a 1000-fold of the mother tincture”, and that “as such the product contains no artificial calming ingredients... as homeopathy is a traditional form of medicine which uses natural ingredients at highly diluted amounts according to homeopathic principles to encourage the body to overcome imbalances naturally.”
11. The advertiser provided evidence in relation to the claims made in the advertisement.
Findings of the Panel
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. 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”. 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.”
14. The Panel was satisfied that a reasonable consumer viewing the advertisement would take it to convey that the advertised Kids Smart Calm product was of demonstrated efficacy in soothing, calming, and relaxing “overexcited children” and aiding their sleep.
15. The Panel reviewed the response provided by the advertiser, including the evidence material. The evidence material was evidence that, to the extent that it could be said to contain ingredients, the product contained ingredients that were homeopathic in origin. The evidence supporting the claims made in the evidence was not evidence that the ingredients were of demonstrated efficacy in calming children, but rather that they had traditionally been used for a wide range of purposes including calming or aiding sleep. The Panel noted that very little of the evidence provided related specifically to use in children for calming or aiding sleep.
16. Advertising claims that are based on evidence of traditional use must clearly and explicitly state that this is the case. They must not state or imply that a product is of demonstrated efficacy if the evidence is only evidence of traditional use or beliefs, and not evidence of actual efficacy.
17. Although the advertisement did state that “the Kids Smart Natural Medicine range is based on the traditional principles of homeopathy”, this information was by no means prominent. Moreover, it failed to make clear that the evidence supporting the claims in the advertisement was not evidence of effectiveness. The advertisement, through its headline and text, stated that the advertised Kids Calm product was an effective medicine. It stated that it could “help settle them down” and was “specially formulated to help soothe, relax, and calm overexcited children... [and] promote restful sleep”. It also stated that the other products in the Kids Smart range were “specifically formulated to help relieve cold & flu symptoms, temporarily soothe mild pain and fever, and relieve runny nose and hayfever.”
18. The Panel was therefore satisfied that the advertisement contained many representations that had not been verified, were likely to arouse unwarranted expectations, were misleading, and abused the trust and exploited the lack of knowledge of consumers. These included the representations that the advertised Kids Smart Calm product can help “settle down”, relax, calm, or soothe children, or aid their sleep, and the representations that the other three products could relieve cold and flu symptoms, pain, fever, runny noses, or hayfever. These aspects of the complaint were found justified.
19. Section 4(2)(f) of the Code prohibits representations that “encourage inappropriate or excessive use” of therapeutic goods.
20. The advertisement stated that “overexcitement, periods of restlessness, and not wanting to do things mum asks” were “a normal part of growing up.” It also stated that “if settling down is a battle in your home or your child gets easily excited, then Kids Smart Natural Medicine may help.” The Panel was satisfied that a reasonable consumer viewing the advertisement could interpret this aspect of it in one of two ways. It could be taken to mean that children exhibiting entirely normal and healthy levels of excitement and restlessness should be given medicine to subdue them. Alternatively, it could be taken to mean that the product was suitable for cases where children where exhibiting abnormal levels of excitement and restlessness of a kind requiring medical attention. The Panel was satisfied that, on either of these interpretations, the advertisement encouraged inappropriate use of the advertised Kids Smart Calm Product. This aspect of the complaint was therefore justified.
Sanctions
21. The Panel requests Pharmacare Laboratories 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 the representations that the Kids Smart Cold & Flu, Kids Smart Pain & Fever, and Kids Smart Runny Nose & Hayfever can relieve cold and flu symptoms, pain, fever, runny noses, or hayfever, unless those representations are clearly and explicitly qualified in a way that makes clear to consumers that the representations are based on evidence of traditional use and beliefs, and not on evidence of actual efficacy;
c)      to withdraw any representations that the advertised Kids Smart Calm product can help “settle down”, relax, calm, or soothe children, or aid their sleep;
d)     not to use the representations in (b) or (c) above in any other advertisement*;
e)      where the representations have 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;
f)       to arrange for publication in the Australian Women’s Weekly of a retraction in the form of, and in accordance with, the conditions set out in the attachment to this determination; and,
g)      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.
22. 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 5 March 2012
For the Panel
 
Jason Korke
Chairman


Appendix A:    Definitions and footnotes
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). It should be noted that HTML metatags and other information which can be retrieved by internet search engines, whether or not it is ordinarily viewed directly by consumers, constitutes advertisement material.
 
 
 
 
*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.


Appendix B:     Retraction
 
An advertisement is to appear in the Australian Women’s Weekly magazine 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.
 

 
RETRACTION
 
An advertisement for Kids Smart products, which Nature’s Way published in this magazine, should not have been published.
 
In the advertisement Nature’s Way unlawfully made claims that the Kids Smart Calm product can help “settle down”, relax, calm, or soothe children, or aid their sleep, and that other Kids Smart products can help relieve cold and flu symptoms, pain, fever, runny noses, and hayfever. The advertisement did not state clearly that the products are not of demonstrated effectiveness, and that the evidence for the claims is evidence of traditional use and beliefs only.
 
A complaint about the advertisement was recently upheld by the Complaints Resolution Panel. The Panel found that the claims were unlawful, misleading, and unverified, and abused the trust of consumers, breaching the Therapeutic Goods Advertising Code.
 
The Panel therefore requested that Pharmacare Laboratories Pty Ltd, the owners of the Nature’s Way brand, publish this retraction.
 
The full text of the Panel’s determination can be found at: www.tgacrp.com.au/complaints
 

 
No other copy should be included in the advertisement.
 

Location:
Early RHS page
Size:
The same size as the original advertisment
Heading:
 
Red, minimum size 20 font, upper case, bold
Text:
Red, black and blue, per above, minimum size 12 font
Text Box:
Red on a white background

 


Appendix C:    Excerpt of the Advertisement
 
 
 
Advertisement Copy: Download

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