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Fisiocrem Solugel - Pronat Group Australia Pty Ltd - Complaint No. 2013-04-003

7 July 2014

Decision under regulation 9 of the Therapeutic Goods Regulations 1990

Pronat Group Australia Pty Ltd has been ordered to undertake a number of actions regarding an internet advertisement for Fisiocrem Solugel, including but not limited to withdrawing the advertisement and publishing a correction statement.

The advertisement, which appeared on the Fisiocrem Solugel website, was the subject of a complaint made to the Complaints Resolution Panel (the Panel) on 4 April 2013 (complaint no. 2013-04-003).

On 28 January 2014, the Panel issued a written determination that the internet advertisement breached sections of the Therapeutic Goods Advertising Code 2007 (the Code).

On 13 March 2014, as a result of Pronat Group 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 13 June 2014.

The decision

The Delegate found that the internet advertisement:

  1. contained claims that were not balanced and had not been previously verified by the sponsor and therefore breached section 4(1)(b) of the Code
  2. was likely to arouse unwarranted and unrealistic expectations of Fisiocrem Solugel's effectiveness and therefore breached 4(2)(a) of the Code
  3. was misleading and therefore breached section 4(2)(c) of the Code
  4. implied that Fisiocrem Solugel was safe or that its use would not cause any harm or that it had no side effects and therefore breached section 4(2)(i) of the Code.

The order

The Delegate ordered Pronat Group Australia Pty Ltd to:

  1. withdraw any representations that Fisiocrem Solugel can offer benefits in relation to:
    1. acting as a treatment for shock, trauma or bodily injury
    2. soothing damaged or irritated nerves in cases of whiplash, low back pain, sciatica, strains and sprains
    3. having anti-inflammatory properties, unless it is so qualified in relation to treating minor inflammation of the skin
    4. assisting the dispersion of swelling.
  2. not use the following representations 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 Therapeutic Goods Regulations 1990 or the Code:
    1. those referred to in (a) above
    2. the product is suitable for use during pregnancy or breastfeeding
    3. the product is used and recommended by health professionals across the world.
  3. where representations in (a) above 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, advise them that the representations should be withdrawn
  4. arrange for the publication of a correction statement on the Fisiocrem Solugel website in the form noted below.

Conditions imposed on the order

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

  1. any representations for Fisiocrem Solugel in any form of advertising, including labelling, are to be clearly qualified as to the nature of the evidence supporting the claims, through clear statements that the claims are based only on evidence of 'traditional use'
  2. within 10 working days of being notified of this order, Pronat Group Australia Pty Ltd will provide evidence of compliance with this order
  3. within 10 working days of being notified of this order, Pronat Group Australia Pty Ltd will provide a written response indicating that it will continue to abide by this order.

Correction statement

The below correction statement is to appear on the Fisiocrem Solugel website for no less than 30 days.

CORRECTION

An advertisement for Fisiocrem Solugel, which was published on this website, should not have been published.

The advertisement did not note that we hold no scientific evidence in support of the efficacy of Fisiocrem Solugel, and that the evidence of efficacy is limited to evidence of traditional use only.

A complaint about the advertisement was recently upheld by the Complaints Resolution Panel.

Following a review of the Panel's recommendation and the available information, the delegate of the Secretary of the Department of Health found that the advertisement breached the Therapeutic Goods Advertising Code, and decided to order that we publish this correction statement.

The full text of the Panel's determination can be found at: Complaints Register

Update

On the 3 July 2014, Pronat Group Australia Pty Ltd provided written assurance to the Delegate that it would comply fully with the regulation 9 orders made on 13 June 2014.