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LaCorium Health Australia Pty Ltd (Complaint No. 2010-09-012)

6 August 2012

Therapeutic Goods Act 1989
Therapeutic Goods Regulations 1990

Decision under regulation 9 of the Therapeutic Goods Regulations 1990 in relation to an advertisement about the product "Crampeze Night Cramps"
(Complaint No. 2010-09-012)

Background

On 14 June 2012, the delegate of the Secretary to the Department of Health and Ageing (the Delegate) for the purposes of Regulations 9 (1) of the Therapeutic Goods Regulations 1990 (the Regulations) issued an order to "LaCorium Health Australia Pty Ltd" (the Advertiser) in relation to an internet advertisement on the website at www.brandsworldwide.com.au about the product "Crampeze Night Cramps".

The decision to issue the order was made by the Delegate after a recommendation was made to the Secretary to the Department of Health and Ageing (the Secretary) by the Complaints Resolution Panel (the Panel) under regulation 42ZCAI(3) of the Regulations on 15 April 2011 in relation to the "Crampeze Night Cramps" advertisement referred to above, the subject of Complaint No. 2010-09-012. The recommendation was made as LaCorium Health Australia Pty Ltd had not fully complied with the Panel's determination issued on 24 January 2011.

The Panel's findings

The Panel found that the advertisement breached sections 4(1)(b), 4(2)(c) and 4(2)(d) of the Therapeutic Goods Advertising Code 2007 (the Code¹). The discussion in relation to these breaches is at paragraphs 11-13 of the Panel's determination which may be accessed from the Panel's Complaint Register at Complaint No. 2010-09-012.

¹ Please refer to the webpage http://www.tga.gov.au/consumers/advertising-complaint-consumer-guide.htm for a summary of the advertising provisions that are commonly breached.

Code breaches in relation to the original advertisement

Having reviewed the advertisement the Delegate concluded that the original advertisement breached sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Code but did not breach section 4(2)(d) of the Code. In reaching this view the Delegate took into account a review by the Therapeutic Goods Administration (TGA) Office of Complementary Medicine of the evidence supplied by the Advertiser, which found that the evidence did not substantiate any of the advertised claims, relating to the relief of night leg cramps, night cramps, muscle cramps, aching legs, aching legs associated with varicose veins, and restless legs.

The Delegate maintains that the advertisement at the time of the complaint contained incorrect and unbalanced statements and claims which were not verified by the Advertiser, in that the evidence did not support the claims because the studies cited in the evidence supplied by the Advertiser involved different active ingredients to those in the Advertiser’s product; was statistically insignificant; was of limited value given the small sample sizes of patients and because of conflicting conclusions reached in the studies; and, was of a general level and therefore did not support the medium level claims made for the Advertiser's product. Given that the claims were unsubstantiated and unbalanced in light of available evidence the Delegate found it was misleading to claim that the product could assist with the conditions referred to in the claims and was therefore in breach of sections 4(1)(b)  and 4(2)(c) of the Code.

The Delegate concluded that the original advertisement also breached section 4(2)(a) of the Code in that the advertisement would be likely to arouse unwarranted and unrealistic expectations of product effectiveness, because the original advertisement clearly suggested that the product had a number of benefits with respect to cramps, aching legs and restless legs and that the evidence submitted by the Advertiser did not support these claims.

Code breaches in relation to the current advertisement

The Delegate considered that the reference to the supplementation benefit of the Advertiser's product was likely to breach section 4(2)(c) of the Code because it is misleading by implying that it will bring about the advertised benefits of the product in that it is likely that a reasonable consumer would consider that a 'supplementation benefit' includes the same therapeutic benefits listed in relation to the initial dose, and would therefore consider that a supplementation dose is the dose that should be taken in order to maintain the therapeutic benefits of the product. The Delegate was of the view that the advertisement breached  section 4(2)(d) of the Code because it exploits the lack of knowledge of consumers who are unlikely to understand, in the context of the advertisement, that a supplementation benefit refers to meeting 25% (only) of the recommended daily intake (RDI) for a vitamin or mineral.

The Order made to LaCorium Health Australia Pty Ltd

Under regulation 9(1) the delegate of the Secretary ordered LaCorium Health Australia Pty Ltd to:

1. withdraw any representations, including implied representations, that Crampeze Night Cramps has therapeutic benefits in relation to cramps (including night cramps, night leg cramps, or muscle cramps) aching legs, aching legs associated with varicose veins, and restless legs, including any representation conveyed by the use of the words 'Crampeze' or 'Night Cramps' in advertising material;
2. not use the representations in (a) above in any other advertisement unless the Advertiser satisfies the delegate of the Secretary to the Department of Health and Ageing that the use of the representations would not result in a contravention of the Act; Regulations or the Therapeutic Goods Advertising Code;
3. 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 representations should be withdrawn.

Conditions imposed on the order

Pursuant to regulation 9(2) the order is subject to the following conditions:

1. the TGA's review in relation to the product, which was initiated following the sponsor's response to a notice issued to the Advertiser under section 31 of the Act dated 2 August 2011 ('the product review'), when completed, will be considered by the delegate of the Secretary to the Department of Health and Ageing in considering any submission by the Advertiser (under paragraph (b) above) that the use of the representations would not result in a contravention of the Act; Regulations or the Therapeutic Goods Advertising Code;
2. within 10 working days of being notified of this order, LaCorium Health Australia Pty Ltd will provide evidence to me of compliance with the order; and
3. within 10 working days of being notified of this order, LaCorium Health Australia Pty Ltd will provide to me a written response indicating that it will continue to abide by the order. 

Outcome

As of 5 July 2012 LaCorium Health Australia Pty Ltd advised the delegate of the Secretary that they have complied, and will continue to comply, with the orders, including notification to their retail partners.

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