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Urinary Tract Support - Health World Limited - Complaint No. 2010/12/013

17 July 2013

Update regarding the Administrative Appeals Tribunal decision of 7 June 2013

17 July 2013

This matter was heard by the Administrative Appeals Tribunal (AAT) on 11-13 February 2013 following an application made by Health World Limited to the AAT for a review of the 28 August 2012 decision.

On 7 June 2013 the AAT made a decision in relation to this matter. While the AAT found that the advertisement breached the Code (but not the Act) (see paragraph 83 of the decision), for the reasons set out in paragraphs 84 to 92 of the decision, the AAT decided not to order that the advertisement or relevant claims be withdrawn or to order a retraction of the advertisement. In those circumstances, the AAT decided to revoke the TGA's 27 April 2012 decision.

Update following review of initial decision

11 February 2013

Following review of the initial decision made on 27 April 2012, a delegate of the Minister for Health and Ageing made a decision on 28 August 2012 which is similar in substance to the initial decision. This matter is currently before the Administrative Appeals Tribunal (AAT) following an application made by Health World Limited to the AAT for a review of the 28 August 2012 decision.

Urinary Tract Support - Health World Limited - Complaint No. 2010/12/013

3 July 2012

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 "Urinary Tract Support"
(Complaint No. 2010/12/013)

Background

On 27 April 2012, the delegate of the Secretary to the Department of Health and Ageing (the Delegate) for the purposes of regulation 9(1) of the Therapeutic Goods Regulations 1990 (the Regulations) decided to order "Health World Limited" (the Advertiser) to carry out actions in relation to a website advertisement at www.ethicalnutrients.com.au, about the product "Urinary Tract Support".

The decision was made by the Delegate on review of the recommendation from the Complaints Resolution Panel (the Panel) under section 42ZCAI(3) of the Regulations on 18 April 2011 in relation to the "Urinary Tract Support" internet advertisement, the subject of Complaint No. 2010/12/013. The recommendation to order Health World Limited to carry out specified actions in relation to the website advertisement was made as Health World Limited had not fully complied with the Panel's determination issued on 8 March 2011.

The Panel's findings

The Panel found that sections 4(1)(b), 4(2)(a), 4(2)(b) and 4(2)(c) of the Therapeutic Goods Advertising Code 2007 (the Code1), and 42DL(1)(c) of the Act together with 5(2) of the Code were breached in relation to the advertisement on the website. The discussion in relation to these breaches is at paragraphs 13 - 22 of the Panel's determination which may be accessed from the Panel's Complaint Register - Complaint No. 2010/12/013.

1 Please refer to the webpage http://www.tga.gov.au/consumers/advertising-complaint-consumer-guide.htm for a summary of the advertising provisions that are commonly breached.

Code breaches

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.

Breach of section 4(1)(b) of the Code

The Delegate was of the view that the claims/indications made in regards to; treating or preventing urinary tract infection or words to the same effect; the relief of the symptoms of cystitis or other urinary tract infections; to providing anti-bacterial, anti-inflammatory, or anti-microbial effects in the urinary tract and reduce swelling were not correct, not represented as balanced statements, and were not supported or verified by the evidence provided to the TGA by Health World Limited. The Delegate was also of the view that although the claims relating to maintaining a healthy urinary system and detoxifying the urinary system were supported by the evidence of traditional use presented to the TGA, the way in which they were presented/worded did not make it clear that these claims are based on the traditional use of the ingredients of the medicine.

Breach of section 4(2)(b) of the Code

The Delegate concluded that the advertisement would be likely to lead consumers to self-diagnosing or inappropriately treating urinary tract infections or cystitis which are serious infections that could lead to serious ailments or conditions. The Delegate was of the view that a person suffering from a urinary tract infection may choose to take Urinary Tract Support instead to relieve burning or pain sensations or, that because of the claimed anti-microbial effect, a consumer may be led to take the product instead of the relevant antibiotics prescribed by a medical practitioner. The Delegate noted that although Health World Limited had made some amendments it remained that the website still represented the products as having a "noted microbial action" and a "detoxifying effect on the urinary system" (which was not limited to the wording that the traditional medicine has been traditionally used for that indication).

Breach of Sections 4(2)(a) and 4(2)(c) of the Code

The Delegate concluded that the representations made for this product such as, "relieves the pain and burning sensation associated with cystitis", "relieve symptoms when you have an acute infection", "broad spectrum anti-bacterial effects", "reduce the painful symptoms faster", "help reduce the frequency of urinary tract infections such as cystitis", "have an anti-microbial effect", "have anti-bacterial effect", "have anti-inflammatory effect", and "reduce swelling" would be likely to arouse unwarranted and unrealistic expectations of product effectiveness and were misleading. It was the Delegate's view that some of these claims mislead by implication that the product could treat or prevent urinary tract infections and which claims were not supported by the evidence provided by Health World Limited to the TGA.

Breach of Section 5(2) of the Code and 42DL(1)(c) of the Act

The Delegate was of the view that the advertisement, the subject of this complaint, contained restricted representations in the use of the words 'cystitis' and 'urinary tract infection(s)', which are captured in Table 1 of Part 2 of Appendix 6 of the Code "Diseases, conditions, ailments and defects for which the advertising of serious forms is restricted" under the entry "Urogenital diseases and conditions". The Delegate concluded that, as the advertisement referred to restricted representations that were neither approved under subsection 42DF(1)or permitted to be used under subsection 42DK(1) of the Act as required, the advertisement was in breach of section 5(2) of the Code. For similar reasons, the Delegate also concluded Health World Limited to be in breach of paragraph 42DL(1)(c) of the Act as the restricted representations were neither approved or permitted to be used by Health World Limited.

The Order made to Health World Limited

Under regulation 9(1) the Delegate ordered Health World Limited as the Advertiser to:

  1. withdraw the website advertisement about the product "Urinary Tract Support" found at the Health World Limited website (www.ethicalnutrients.com.au), the subject of Complaint No. 2010/12/013, from further publication;
  2. withdraw any representations that the advertised product has or may have benefits in relation to, the treatment or prevention of cystitis or urinary tract infections, to relieving symptoms of cystitis or other urinary tract infections, providing anti-bacterial, anti-inflammatory, or anti-microbial effects in the urinary tract, reduce swelling or representations/claims to the same effect;
  3. withdraw any representations that the advertised product has or may have benefits in relation to, maintaining a healthy urinary system, detoxifying the urinary system, or words to the same effect, unless these indications/claims are worded to the effect that "This (traditional) medicine has been traditionally used for (indication/claim)";
  4. not use the representations in (a) or (b) above in any other advertisement unless Health World Limited satisfies the Therapeutic Goods Administration (TGA) 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);
  5. 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; and
  6. to arrange for the publication on the www.ethicalnutrients.com.au website of a retraction in the form of, and in accordance with, the conditions set out in Attachment K;

Conditions imposed on the order

  1. within 10 working days of being notified of this order, Health World Limited will provide evidence to me of compliance with this order; and
  2. within 10 working days of being notified of this order, Health World Limited will provide to me a written response indicating that Health World Limited will continue to abide by this order.

Outcome

On 26 June 2012, Health World Limited lodged an application for reconsideration of this decision under Regulation 48 of the Therapeutic Goods Regulations 1990.

Attachment K

Retraction

An advertisement is to appear on the homepages of the website at www.ethicalnutrients.com.au within 14 days.

A copy of the retraction advertisement, and the page on which it will be published, is to be provided to the TGA Advertising Unit for approval before publication.

Location: Website front page, so that it can be viewed without scrolling the page
Size: No less than 500 pixels wide and 200 pixels high
Heading:

Arial or Helvetica

Red on white background

The letters should be no less than 20 pixels in height, and should be no smaller than any other body text on the page

Bold

Text:

Arial or Helvetica

Red, black and blue on white background

The letters should be no less than 14 pixels in height, and should be no smaller than any other body text on the page

Bold

Text Box: Red on white background
Duration: 120 days
HTML: In the case of website retractions, the retraction is to be presented in ordinary and valid HTML 4 in the body of the page. Pop-ups, Flash objects, or images are not acceptable formats for website retractions.

RETRACTION

An advertisement for Ethical Nutrients Urinary Tract Support, which we published on this website, should not have been published.

In the advertisement we unlawfully made claims that the product has or may have benefits in relation to the treatment or prevention of cystitis or urinary tract infections, to relieving symptoms of cystitis or other urinary tract infections, providing anti-bacterial, anti-inflammatory, or anti-microbial effects in the urinary tract, reduce swelling or representations/claims to the same effect.

A complaint about the advertisement was recently upheld by the Complaint Resolution Panel. We provided evidence which was subsequently found to be insufficient to support the claims we made, and the delegate of the Secretary to the Department of Health and Ageing found that the claims were unlawful, misleading, unverified and breached the Therapeutic Goods Advertising Code.

The delegate of the Secretary therefore requested we publish this retraction.

The full text of the Panel's determination can be found at: www.tgacrp.com.au/complaints