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COMPLAINTS RESOLUTION PANEL DETERMINATION Complaint 2015-01-010 Pjur ARTG ID: 160826 Meeting held 2 April 2015 Complaint summary^ Complainant Advertiser Subject matter of complaint Type of determination Sections of the Code, Regulations or Act found to have been breached* Sections of the Code, Regulations or Act found not to have been breached* Sanctions Requested anonymity Pjur Group Australia Pty Ltd Internet advertisement Final Code sections 4(2)(i), 4(6)(b), 6(3) Code sections 4(2)(f), 4(2)(h) Withdrawal of representations Withdrawal of advertisement * only sections of the Code, Act, or Regulations that were part of the complaint or were raised by the Panel are listed Page 1 of 7

The advertisement(s)^ 1. The complaint concerned an internet advertisement for the range of Pjur products, including the pjur med Natural Glide and pjur med Premium Glide lubricants, published at the website www.pjur.com.au and viewed by the complainant in January 2015. 2. The advertisement comprised three pages of website advertising [the advertisement], the first of which was an item entitled Sexual Healthcare with an illegible array of five product pack shots along the bottom of the page, the second page was devoted to the product pjur med Natural Glide and the third to the product pjur med Premium Glide. The advertisement included representations such as This category boasts products with natural and natural identical ingredients recommended by doctors and pharmacists, the hormonal balance may be disturbed by stress or during pregnancy or lactation the highly compatible pjur med lubricants provide soothing relief, Safe for daily use, 5-star-guarantee = dermatological tests on humans with neurodermatitis (free of eczema) under clinical conditions tolerated very well /Nov 2011 and other claims. 3. An excerpt of the advertisement can be viewed in the relevant Appendix to this determination. The product(s) 4. The advertisement promoted pjur med Natural Glide, pjur med Premium Glide lubricants (ARTG 160826). The advertiser(s) 5. The advertiser was Pjur Group Australia Pty Ltd. The complaint^ 6. The complainant requested anonymity. 7. The complainant alleged that the advertisement breached the following sections of the Code: a) Section 4(6)(b)(ii) because of the inclusion of the words recommended by doctors and pharmacists ; b) Sections 4(2)(f) and 4(2)(i) of the Code because of the wording Safe for daily use ; and c) Section 4(2)(h) of the Code in relation to the 5-star-guarantee included in the advertisement. Additional matters raised by the Panel 8. Under sub-regulation 42ZCAH(1), the Panel is empowered to raise matters other than those specified in the complaint, where the Panel is satisfied that the advertisement to which the complaint relates contains matter that is not mentioned in the complaint, which may contravene the Act, Regulations, or the Code in other ways. The Panel was so satisfied and raised as an additional matter, a possible breach of section 6(3) of the Code because the advertisement may lack certain mandatory information including the statements always read the label and use only as directed. Page 2 of 7

The advertiser s response to the complaint^ 9. Following a request for an extension of time in which to respond to the complaint, and, as explained in the responses made on behalf of Pjur Australia Pty Ltd to previous complaints about the advertising of pjur products, some background as to the registration status of the various products was given and the Panel was assured that the respondent had advised Pjur Australia Pty Ltd to remove the website pending review of the material. 10. In relation to a possible breach of section 6(3) of the Code, the respondent acknowledged that the mandatory statements Always read the label and Use only as directed had not been included. 11. In response to the allegation of breaches of sections 4(2)(f) and 4(2)(i) in relation to the claim safe for daily use, the respondent disagreed and stated that The statement safe for daily use is a statement that will be understood by the general public to mean that the product is suitable for everyday use and When the web pages are reviewed we will reconsider this wording and may choose to substitute the word safe with suitable if it is still deemed that the use of the word safe in this context is unsuitable. 12. The respondent rejected the complaint about the 5 star guarantee as in breach of section 4(2)(h) of the Code, quoted the full version of the representation, i.e. 5 star guarantee=dermatological tests on humans with neurodermatitis (free of eczema) under clinical conditions tolerated Very well * Nov 2011 and argued that the statement is a reference to the quality of the product (including dermatological testing) and that is it is not referring to the product being effective in all cases. 13. In relation to the allegation of breach of section 4(6)(b)(ii) of the Code because of the words recommended by doctors and pharmacists, the respondent said that this category boasts products with natural and nature identical ingredients recommended by doctors and pharmacists was not a direct recommendation of the product, but is referring to the ingredient within the products. However, it also was accepted that this could be misinterpreted and so the wording would be reviewed. 14. The respondent noted that the complainant had referred to the words sexual dysfunction as being a prohibited representation without any further explanation. Findings of the Panel breaches of the Code 15. Section 4(2)(f) of the Code prohibits representations that encourage inappropriate or excessive use of therapeutic goods. Section 4(2)(i) of the Code prohibits representations that the goods advertised are safe, harmless, or free of side-effects. 16. The complainant alleged breaches of these sections of the Code in relation to the claim safe for daily use. The Panel was of the view that this representation would not be likely to encourage excessive use of the product by consumers and found that the claim was not in breach of section 4(2)(f) of the Code. 17. The Panel found, therefore, that this aspect of the complaint was not justified. 18. With respect to the alleged breach of section 4(2)(i), the Panel was of the view that the respondent misinterpreted the likely take out by a reasonable consumer of these words and was Page 3 of 7

satisfied that the claim represented the goods to be safe, clearly in breach of this section of the Code. The Panel noted that the advertiser intended to consider rewording the claim. 19. The Panel found, therefore, that this aspect of the complaint was justified. 20. Section 4(2)(h) of the Code prohibits advertisements for therapeutic goods that contain any claim, statement or implication that it is effective in all cases of a condition. In relation to the 5-star-guarantee, the Panel expressed some concern that such a claim would be used in relation to clinical tests. However, the Panel also was of the view that it was not giving a guarantee that the product would be effective for everyone, i.e. offering a certain, guaranteed or sure cure, but rather was referring to the safety of the product. For this reason, the Panel was satisfied that the advertisement did not breach section 4(2)(h) of the Code. 21. The Panel found, therefore, that this aspect of the complaint was not justified. 22. Section 4(6)(b) of the Code prohibits representations that therapeutic goods are endorsed by healthcare professionals. 23. The Panel was satisfied that the advertisement breached this provision because of the representation this category boasts products with natural and nature identical ingredients recommended by doctors and pharmacists and completely discounted the respondent s attempt to justify the claim. 24. The Panel found, therefore, that this aspect of the complaint was justified. 25. Section 6(3) requires the inclusion of the words always read the label (section 6(3)(c) of the Code), and use only as directed (section 6(3)(d) of the Code). The Panel was satisfied that the advertisement did not include these mandatory statements, noting that the advertiser conceded that they had not been included. 26. The Panel found, therefore, that this aspect of the complaint was justified. 27. The Panel noted that the brief, unexplained reference to sexual dysfunction referred to by the complainant in the complaint did not provide a sufficient basis for its further consideration by the Panel. Sanctions 28. The Panel requests Pjur Group Australia Pty Ltd, in accordance with subregulation 42ZCAI(1) of the Therapeutic Goods Regulations 1990: a) to withdraw the advertisement from further publication; b) to withdraw any representations that have been found in breach of the Code above, including that the products are safe, and that they are endorsed by healthcare professionals. c) not to use the representations in (b) above in any other advertisement*; d) 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 representation(s) should be withdrawn; and, Page 4 of 7

e) within 14 days of being notified of this request, to provide evidence to the Panel of its compliance, including a response in writing that it will comply with the Panel s sanctions, and where appropriate, supporting material such as copies of instructions to advertising agents or publishers, or correspondence with retailers and other third party advertisers. 29. The advertiser s attention is drawn to the provisions of sub-regulations 42ZCAI(3) and (4) which permit the Panel to make recommendations to the Secretary in the event of noncompliance with this request. Dated 27 August 2015 For the Panel Judith Brimer Executive Officer Page 5 of 7

Appendix A: Definitions and footnotes In this determination, unless otherwise specified: a) the Act means the Therapeutic Goods Act 1989; b) the Regulations means the Therapeutic Goods Regulations 1990; c) the Code means the Therapeutic Goods Advertising Code; d) the Register means the Australian Register of Therapeutic Goods; e) any other advertisement appearing in sub-regulation 42ZCA1(1)(d) is not confined to advertisements in specified or broadcast media (in relation to which complaints may be made to the Panel under Regulation 42ZCAB). It should be noted that HTML metatags and other information which can be retrieved by internet search engines, whether or not it is ordinarily viewed directly by consumers, constitutes advertisement material. ^Readers of the determination should note that the sections complaint summary, the advertisement(s), the complaint, and [a party] s response to the complaint, are summaries that are intended to aid readers of this document. In reaching its decision, the Panel considered all of the material before it, including material that may not be mentioned specifically in the summaries. The summaries do not form part of the Panel s reasoning. *Under regulation 42ZCAI of the Regulations, the Panel may request that a representation not be used in any other advertisement unless the advertiser satisfies the Panel that the use of the representation would not result in a contravention of the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 or the Therapeutic Goods Advertising Code. Under the Panel s procedures, the Panel will not ordinarily give additional consideration to such a matter unless significant new material that was not available at the time of the Panel s determination has become available, or until at least 12 months have passed since the Panel s request was made. Page 6 of 7

Appendix B: Excerpt of the Advertisement Page 7 of 7