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Berocca Performance - Bayer Australia Limited - Complaint No. 2010-10-017
Update following compliance with decision
21 November 2013
On 26 September 2013, Bayer Australia Limited advised the TGA that they have complied with and will continue to comply with the regulation 48 decision made by the delegate of the Minister for Health on 15 July 2013. This includes withdrawal of any representations, including implied representations, that "Berocca Performance" has been clinically trialled and demonstrated to improve concentration and reduce tiredness, and that they will not use these representations in any other advertisement.
Update following review of initial decision
25 July 2013
Following an application for review under regulation 48 of the Therapeutic Goods Regulations 1990 by Bayer Australia Limited in relation to the regulation 9 order for "Berocca Performance", the Delegate of the Minister for Health and Ageing on 15 July 2013, confirmed the initial decision made on 8 March 2013.
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 "Berocca Performance"
(Complaint No 2010-10-017)
Regulation 9 of the Therapeutic Goods Regulations 1990 permits the Secretary of the Department of Health and Ageing ('the Secretary') or her delegate to order a person, such as the sponsor of therapeutic goods, to undertake certain actions related to the advertising of therapeutic goods. Such an order can only be made on the recommendation of the Complaints Resolution Panel ('the Panel'), which is a statutory committee that examines complaints about advertisements for therapeutic goods.
On 8 March 2013, the Therapeutic Goods Administration ('TGA') delegate of the Secretary (the Delegate) made an order under regulation 9 in relation to Bayer Australia Ltd about an internet advertisement at www.beroccatwist.com regarding "Berocca Performance" ('Initial Decision'). This order was made following a recommendation by the Panel on 10 May 2011, Complaint No 2010-10-017 in relation to a complaint made to the Panel dated 21 October 2010. The recommendation was made by the Panel as Bayer Australia Ltd had not fully complied with the Panel's determination issued on 14 March 2011.
The Panel's findings
The Panel found in its 14 March 2011 determination that the Bayer Australia Ltd internet advertisement breached sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Therapeutic Goods Advertising Code 2007 (the Code). The discussion in relation to the Panel's findings is at paragraphs 14-23 of the Panel's determination which may be accessed from the Panel's Complaint Register at Complaint No. 2010-10-017.
The Delegate agreed that the Berocca Performance internet advertisement at www.beroccatwist.com breached 4(1)(b), 4(2)(a), and 4(2)(c) of the Code.
The Delegate reviewed the available information including the complaint, material from Bayer Australia Ltd, the website advertisement and the Panel's determination. The Delegate agreed with the Panel that the website advertisement included the claim that Berocca Performance had been clinically trialled and demonstrated to improve concentration and reduce tiredness. Bayer Australia Ltd was responsible for this website. The Delegate did not consider other statements about the product identified by the complainant because Bayer Australia Ltd was not apparently responsible for the websites on which those statements were made.
The central issue considered by the Delegate was whether or not Bayer Australia Ltd held sufficient evidence to support the statement 'Berocca Performance has been clinically trialled and demonstrated to improve concentration and reduce tiredness'.
Following consideration of the available information the Delegate decided that Bayer Australia Ltd did not hold consistent, supportive and clinically significant evidence that Berocca Performance has been clinically trialled and demonstrated to improve concentration and reduce tiredness. On this basis, the Delegate found that the statement:
- was incorrect, unbalanced and not verified by Bayer Australia Ltd and was therefore in breach of section 4(1)(b) of the Code;
- was likely to arouse unwarranted and unrealistic expectations of the effectiveness of Berocca Performance and was therefore in breach of section 4(2)(a) of the Code; and
- was misleading and was therefore in breach of section 4(2)(c) of the Code.
The Delegate ordered Bayer Australia Ltd to:
- withdraw any representations, including implied representations, that:
- Berocca Performance has been clinically trialled and demonstrated to improve concentration and reduce tiredness;
- not use the representations in (a) 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.
Conditions imposed on the order
In addition, the Delegate imposed the following conditions under regulation 9(2) in relation to the order:
- within 10 working days of being notified of the order, that Bayer Australia Ltd provide evidence to the Delegate of compliance with the order; and
- within 10 working days of being notified of the order, that Bayer Australia Ltd provide to the Delegate a written response indicating that Bayer Australia Ltd will continue to abide by the order.
On 15 May 2013, Bayer Australia Limited submitted a request for reconsideration of the Initial Decision under Regulation 48 of the Therapeutic Goods Regulations 1990.