Nurofen - Reckitt Benckiser (Australia) Pty Ltd - Complaint No. 2011/06/001
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 "Nurofen"
(Complaint No. 2011/06/001)
On 13 June 2012, the delegate of the Secretary to the Department of Health and Ageing (the Delegate) for the purposes of sub regulation 9(1) of the Therapeutic Goods Regulations 1990 (the Regulations) issued an order to Reckitt Benckiser (Australia) Pty Ltd (the Advertiser) in relation to a television advertisement about "Nurofen".
The decision to issue the order was made by the Delegate after a recommendation was made to the Secretary of the Department of Health and Ageing (the Secretary) by the Complaints Resolution Panel (the Panel) under sub regulation 42ZCAI(3) of the Regulations on 15 September 2011, in relation to a "Live Well Headache" television advertisement for "Nurofen". The recommendation was made as the Advertiser had not fully complied with the Panel's determination issued on the 30 August 2011.
Nurofen is a registered medicine (Australian Register of Therapeutic Goods (ARTG) number 144202) with the following indications:
- "The temporary relief of pain (and discomfort) associated with headache, migraine headache, tension headache, dental procedures, backache, muscular aches and pains, period pain and rheumatic pain where inflammation is present and the aches and pains associated with colds and flu. Reduces fever. The temporary relief of pain associated with arthritis."
The Panel found that the complaint was formally acceptable in accordance with the Panel's procedures, and took the view that it was clear that, by referring to the claims as "misleading", the complainant alleged breach of paragraph 4(2)(c) of the Therapeutic Goods Advertising Code 2007 (the Code). The Panel also noted that, while the product packaging in itself did not fall within the Panel's jurisdiction, the relevant words ("targeted relief from pain") were clearly legible on a product image in the television advertisement and as such formed part of the advertisement. The discussion of this breach may be found in paragraphs 14 to 30 of the Panel's determination which may be accessed from the Panel's Complaint Register at Complaint No. 2011/06/011.
The Delegate concluded that the advertisement, which was the subject of the complaint, breached sections 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c) and 5(2) of the Code. As the advertisement also contained a restricted representation that has not been approved or permitted for use under the Therapeutic Goods Act 1989 (the Act), subsection 42DL(1)(c) of the Act was also contravened.
The delegate reviewed the advertisement the subject of the complaint and took into consideration the Panel's determination, the Advertiser's submissions and responses in relation to the advertisement and the advice from the OTC Medicine Evaluation Section.
The Delegate was of the view that a reasonable consumer viewing the television advertisement about Nurofen would form a view that Nurofen goes straight to the source of the pain, targets the site of the pain, become concentrated there, and has effects only there - in this case, to the painful part of the head. The Delegate was also of the view that a reasonable consumer would form that view because of the representations and the imagery conveyed in the advertisement, whether considered individually (the representations or the imagery), or in the context of the advertisement as a whole.
The Delegate noted the comments in the OTC Medicines Evaluation Report and accepted the claim that Nurofen goes to the source of the pain may not be misleading, however, the conclusion in that Report did not take into account the effect of this claim when combined with the visual representations in the television advertisement about Nurofen.
Taking into consideration submissions made by the Advertiser, advice by the OTC Medicines Evaluation Section and the conclusion reached by the Panel in relation to the television advertisement Live Well Headache, it was the Delegate's view that the television advertisement was misleading by emphasising that Nurofen goes straight to the source of the pain, becomes concentrated there and does not go anywhere else. A reasonable consumer, noting the representations "goes straight to the source of the pain" and the visual imagery of the medicine ascending from the neck to the head, individually or in the context of the advertisement as whole, would conclude that Nurofen travelled specifically to the areas of the body affected by the pain, that Nurofen would not travel to other parts of the body to a significant degree, and would only have an effect on that painful part of the body. The Delegate found therefore that the claim "goes straight to the source of the pain" breaches paragraph 4(2)(c) of the Code as it was misleading.
The delegate of the Secretary ordered Reckitt Benckiser (Australia) Pty Ltd to:
- withdraw the "Live Well Headache" television advertisement ("the advertisement") about the therapeutic good "Nurofen" which was the subject of the complaint;
- withdraw any representations, in the context of headaches, that the advertised therapeutic good "Nurofen" goes "straight" to the source of the pain;
- not use the representations in (b) above in any other advertisement; and
- 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 representations should be withdrawn.
Pursuant to subregulation 9(2) of the Regulations, the order is subject to the conditions that within 10 working days of being notified of this order, Reckitt Benckiser (Australia) Pty Ltd is required to provide evidence to the delegate of the Secretary of compliance by Reckitt Benckiser (Australia) Pty Ltd with the order set out in paragraphs (a) to (d) above including a written response indicating that they will continue to abide by this order.
By letter dated 17 July 2012 Reckitt Benckiser (Australia) Pty Ltd have advised the delegate of the Secretary that they have complied, and will continue to comply, with the orders.