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Nurofen - Reckitt Benckiser (Australia) Pty Ltd - Complaints No. 2012-08-010 and 2012-10-024

9 May 2014

Decision under regulation 9 of the Therapeutic Goods Regulations 1990

Reckitt Benckiser (Australia) Pty Ltd has been ordered to undertake a number of actions regarding a website advertisement for a range of Nurofen products, including but not limited to withdrawing certain representations made in the advertisement.

The internet advertisement was the subject of two complaints made to the Complaints Resolution Panel (the Panel) - no. 2012-08-010 lodged on 8 August 2012 and no. 2012-10-024 lodged on 28 October 2012.

On 12 June 2013, the Panel issued a written determination that the advertisement breached a section of the Therapeutic Goods Advertising Code 2007 (the Code).

On 16 July 2013, as a result of Reckitt Benckiser (Australia) 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 11 April 2014.

The decision

The Delegate found the website advertisement was misleading or likely to be misleading and was therefore in breach of section 4(2)(c) of the Code.

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The order

The Delegate ordered Reckitt Benckiser (Australia) Pty Ltd to:

  1. withdraw any representations, including implied representations, that imply that any two or more Nurofen products that contain equivalent ibuprofen quantities and include the same product specific indications on the Australian Register of Therapeutic Goods:
    1. are effective only in treating a particular condition or conditions or pain in a particular part or parts of the body; or
    2. are not effective in treating other conditions or pain in other parts of the body, where they are indicated for those other conditions or pain in particular parts of the body
  2. not use the representations referred to in paragraph (a) above in any other advertisement unless the Advertiser satisfies the Secretary that the use of the representations would not result in a contravention of the Therapeutic Goods Act 1989 (the Act), the Regulations or the Therapeutic Goods Advertising Code 2007 (the Code)
  3. where the representations in paragraph (a) 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 those parties that the representations should be withdrawn.

Conditions imposed on the order

Additionally, the Delegate imposed the following conditions under regulation 9(2) in relation to the order:

  1. any representation that refers to two or more Nurofen products that contain equivalent quantities of ibuprofen and include the same product specific indications on the Australian Register of Therapeutic Goods must clearly indicate, in the body of the advertisement, that the two products can be used for the same purposes and are interchangeable (or words to that effect). An asterisk in the body of an advertisement with full detail explained elsewhere, for example in a footnote, will not be sufficient to satisfy this condition
  2. within 10 working days of being notified of this order, Reckitt Benckiser (Australia) Pty Ltd will provide evidence of compliance with this order
  3. within 10 working days of being notified of this order, Reckitt Benckiser (Australia) Pty Ltd will provide a written response indicating that Reckitt Benckiser (Australia) Pty Ltd will continue to abide by this order.

Update

On the 9 May 2014 Reckitt Benckiser (Australia) Pty Ltd provided written assurance to the delegate of the Secretary that they would comply fully with the regulation 9 orders made on 11 April 2014.

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