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Nature's Way Kids Smart Natural Medicine Range - PharmaCare Laboratories Pty Ltd - Complaint No. 2011-10-027
Decision under regulation 9 of the Therapeutic Goods Regulations 1990
PharmaCare Laboratories Pty Ltd has been ordered to undertake a number of actions regarding a print advertisement for the Nature's Way Kids Smart Natural Medicine range of products, including but not limited to withdrawing the advertisement.The print advertisement, which was published in the Australian Women's Weekly magazine in October 2011, was the subject of a complaint made to the Complaints Resolution Panel (the Panel) on 19 October 2011 (complaint no. 2011-10-027).
On 5 March 2012, the Panel issued a written determination that the print advertisement breached sections of the Therapeutic Goods Advertising Code 2007 (the Code).
On 15 August 2012, as a result of PharmaCare Laboratories Pty Ltd not fully complying with the Panel's determination, the Panel recommended the TGA delegate of the Secretary of the Department of Health (the Delegate) review the matter.
Following investigation, the Delegate's decision was made on 13 June 2013.
The Delegate found that the print advertisement:
- was incorrect and unbalanced and therefore in breach of section 4(1)(b) of the Code
- was likely to arouse unwarranted and unrealistic expectations of product effectiveness and was therefore in breach of section 4(2)(a) of the Code
- was misleading or likely to be misleading and was therefore in breach of section 4(2)(c) of the Code
- contained unverified and misleading representations that abused the trust and exploited the lack of knowledge of consumers, and was therefore in breach of section 4(2)(d) of the Code
The Delegate ordered PharmaCare Laboratories Pty Ltd to:
- withdraw the print advertisement, which was published in the Australian Women's Weekly magazine in October 2011, from further publication
- withdraw representations that Kids Smart Calm, Kids Smart Cold & Flu, Kids Smart Pain & Fever, and Kids Smart Runny Nose & Hayfever are suitable for the claimed indications unless those representations are clearly and explicitly qualified in such a way that makes clear to consumers that those representations are based on evidence of traditional 'homeopathic' use and beliefs and not on evidence of actual efficacy
- not use the representations in (b) above in any other advertisement
- where the representations have been provided to other parties, such as retailers or website publishers, and where there is a reasonable likelihood that the representations have been published or are intended to be published by such parties, to advise them that the representations should be withdrawn
- to arrange for the publication of a retraction on its website.*
*See 'Regulation 48 review' below.
Conditions imposed on the order
Additionally, the Delegate imposed the following conditions under regulation 9(2) in relation to the order:
- within 10 working days of being notified of this order, PharmaCare Laboratories Pty Ltd will provide evidence of compliance with this order
- within 10 working days of being notified of this order, PharmaCare Laboratories Pty Ltd will provide a written response indicating that it will continue to abide by this order.
Regulation 48 review
The Minister for Health received from PharmaCare Laboratories Pty Ltd, by letter dated 20 September 2013, a request for review under regulation 48 of the Therapeutic Goods Regulations 1990 in relation to the 'initial decision' made by the Delegate.
Following review of the initial decision, a delegate of the Minister for Health made a decision on 19 November 2013 that was similar in substance to the initial decision. While the delegate of the Minister found that the advertisement breached the Code, the delegate decided not to order a retraction of the advertisement.
On 19 December 2013, PharmaCare Laboratories Pty Ltd confirmed it had stopped the advertising of, and had discontinued, the Nature's Way Kids Smart Natural Medicine Range of products. PharmaCare Laboratories Pty Ltd also confirmed it would abide by the regulation 48 decision.