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Virility Pills VP-RX - Turkmarket - Complaint No. 2010-12-020

5 April 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 "Virility Pills VP-RX"
(Complaint No 2010-12-020)

Background

On 28 November 2012, the delegate of the Secretary to the Department of Health and Ageing (the Delegate) for the purposes of section 9(1) of the Therapeutic Goods Regulations 1990 (the Regulations) issued an order to Turkmarket in relation to an internet advertisement at www.virilitypills.com.au about the product "Virility Pills VP-RX".

The decision to issue the order was made by the Delegate after a recommendation was made to the Secretary to the Department of Health and Ageing (the Secretary) by the Complaints Resolution Panel (the Panel) under section 42ZCAI(3) of the Regulations on 13 July 2011 in relation to the "Virility Pills VP-RX" advertisement referred to above, the subject of Complaint No 2010-12-020. The recommendation was made as Turkmarket had not fully complied with the Panel's determination issued on 28 April 2011.

The Panel's findings

The Panel found that the "Virility Pills VP-RX" internet advertisement breached sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(h), 4(2)(i), 4(4), 4(5), 4(6)(b)(iv), 4(7) and 6 of the Therapeutic Goods Advertising Code 2007 (the Code1) and sections 22(5) and 42DM(1) of the Therapeutic Goods Act 1989 (the Act). The discussion in relation to the Panel's findings may be found at paragraphs 11 - 22 of the Panel's determination which may be accessed from the Panel's Complaint Register at complaint No. 2010-12-020.

  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 was of the view that the "Virility Pills VP-RX" represented in the internet advertisement at www.virilitypills.com.au at the time of the complaint and when viewed on 21 February 2011, 22 February 2012, 7 September 2012 and 27 November 2012 breached sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(h), 4(2)(i), 4(4), 4(5), 4(6)(b)(iv), 4(7) and 6 of the Code and sections 22(5) and 42DM(1) of the Act.

Considerations

The product, subject of this complaint, is included in the Australian Register of Therapeutic Goods (ARTG) as a 'listed' medicine at AUST L 173280. The indications for this product comprise of 'low level' claims using words such as, 'involved', 'supports normal male physiology/sexual health/reproductive system' and, 'supports normal healthy immune function'.

In considering this matter the Delegate noted that Turkmarket had submitted information to the TGA in the form of a "Summary Table" of evidence. It was the Delegate's opinion that this material could not reasonably be regarded as adequate evidence to support any of the claims in the advertising; as only 7 of the 13 active ingredients were referred to with no evidence being provided in relation to the other 6 active ingredients; and, as only one of the ingredients (zinc) was at the required minimum dose for therapeutic effect.

The Delegate reviewed the determination No 2010-12-020 and agreed with the Panel that the representations implied that the product might assist with such conditions as such as premature ejaculation and impotence and, that it could be used for indications other than those indications found in the ARTG for the advertised product. The Delegate was satisfied that these representations were unverified, misleading and likely to arouse unwarranted expectations of product effectiveness and therefore in breach of sections 4(1)(b, 4(2)(a) and 4(2)(c) of the Code.

The Delegate also agreed with the Panel those claims including, "Safe" "effective", "NO harmful ingredients", "NO side effects", "this is the pill that does it all" and, "100% satisfaction guaranteed" were representations that implied the product was effective in all cases and that is was safe or that their use cannot cause any harm or side effects and was therefore in breach of sections 4(2)(h) and 4(2)(i) of the Code.

The representations made on the website at www.virilitypills.com.au included an endorsement by a person who could be clearly identified as a healthcare professional (Dr Satya of India) who made references to his 'clinical experience' with the product in question and his length of practice in both modern medicine and herbal medicine. The Delegate agreed with the Panel and found that this was a breach of section 4(6)(b)(iv) of the Code.

The representations made for this product also included testimonials from consumers who allegedly found that there was a permanent increase in the length and/or girth of their penis and/or an increase in their libido. The Delegate found that these testimonials breached section 4(7) of the Code in that they were misleading, not documented and were atypical.

Because the product was advertised by Turkmarket for indications other than those that are included in the ARTG the Delegate found that the advertisement breach section 22(5) of the Act.

The Delegate also found that, because of the breaches already noted, the advertisement was in breach of section 42DM(1) of the Act in that the advertisement does not comply with the Code. Accordingly, the Delegate considered it necessary to issue the order, with a retraction, under regulation 9 of the Regulations to Turkmarket requiring it to comply with all the actions set out in the order.

The order

The delegate of the Secretary ordered Turkmarket to:

  1. withdraw the website advertisement about the product "Virility Pills VP-RX" found at the Virility Pills VP-RX website (www.virilitypills.com.au );
  2. withdraw any representations, including implied representations, that the advertised product has effects in relation to sexual stamina, sex drive, orgasms, sexual performance, impotence, erections, penis size, the appearance of the penis, or male enhancement, or that it is clinically proven to have any such effects;
  3. not use the representations in (b) above in any other advertisement;
  4. 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;
  5. the withdrawal of representations includes the withdrawal of such representations from metadata which is not visibly displayed on the web page, but which influences search engine results, including HTML content such as "keywords" and "description" information contained within the HTML source for the page; and
  6. to arrange for the publication on the website www.virilitypills.com.au of a retraction in the form of, and in accordance with, the conditions set out in the attachment to the order.

Conditions imposed on the order

Pursuant to section 9(2) of the Regulations, the order was subject to the following conditions:

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

Outcome

A check of the website at www.virilitypills.com.au on 19 March showed that Turkmarket had substantially amended their advertising for Virility Pills VP-RX, however full compliance has not yet been achieved. The TGA are continuing to work closely with Turkmarket to ensure full compliance with the regulation 9 order.

Retraction notice

A retraction notice to appear on the website www.virilitypills.com.au at the earliest opportunity.

A copy of this retraction notice, and the page on which it will be published, is to be provided to the delegate of the Secretary for approval before publication.

RETRACTION

An advertisement for Virility Pills, which we published on this website, should not have been published.

In the advertisement we unlawfully made claims that the product could have benefits in relation to sexual stamina, sex drive, orgasms, sexual performance, impotence, erections, penis size, the appearance of the penis, or male enhancement, and that it is clinically proven to have any such effects.

A complaint about the advertisement was upheld by the Complaints Resolution Panel and was recently upheld by the delegate of Secretary to the Department of Health and Ageing. We provided no persuasive evidence to support the claims we made, and the delegate to the Secretary found that the claims were unlawful, misleading, unverified and breached the Therapeutic Goods Advertising Code and the Therapeutic Goods Act.

The delegate of the Secretary requested that Turkmarket publish this retraction.