Pharmacare Laboratories Pty Ltd. Code sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d), 4(4), 5(2) Withdrawal of advertisements

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1 COMPLAINTS RESOLUTION PANEL DETERMINATION Complaint Horny Goat Weed for Him ARTG ID: AUST L Meeting held 19 January 2017 Complaint summary^ Complainant Advertisers Requested anonymity Pharmacare Laboratories Pty Ltd Pharmacy Online 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 Internet advertisements Final Act section 22(5) Code sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d), 4(4), 5(2) None Withdrawal of advertisements Withdrawal of representations * 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 10

2 The advertisement(s)^ 1. The complaint concerned internet advertisements published on the websites and which were viewed by the complainant on 22 August The complaint also included an advertisement copy from the website 2. The Pharmacy Online advertisement displayed an image of the product adjacent to the name of the product and included a product description, as follows: A natural supplement (tablet) that helps treat factors that cause sexual dysfunction, lifts libido levels, increases energy, stamina and endurance, circulation and decreases stress. MORE THAN 1 MILLION AUSTRALIAN MEN SUFFER FROM SEXUAL DYSFUNCTION Lifestyle changes can lift libido such as exercising, diet and relaxing. BUT other problems including fatigue, prostate enlargement and low testosterone levels cannot be rectified by a lifestyle change This is where Horny Goat Weed comes in. Horny Goat Weed is a potent combination of the top herbs and nutrients traditionally known as aphrodisiacs. It is designed to traditionally support male sexual dysfunction and desire and may help with Libido Energy A positive emotional balance Circulation Performance levels Stamina MORE REASONS TO TAKE HORNY GOAT WEED PLUS Natural alternative. Avoid Viagra, hormone replacement or implanted medical devices. Helps tackle the cause of impotence. It can help with the physiological factors causing impotence, such as fatigue, poor circulation and loss of libido. Medically recognised ingredients: It combines the most effective natural aphrodisiacs used traditionally over thousands of years and proven by modern medical research. 3. The Naturopathica advertisement included a pack shot of the product which included the claims Circulation, Stimulation, Stamina, Desire. The wording of the advertisement included the representations high potency formulation, boost your body s natural drives and desires, Enhance libido and support male sexual function, Help increase peripheral circulation, stimulation, stamina and endurance.. and Encourage and support the body s natural drives and desires. 4. The Chemist Warehouse advertisement included a pack shot of the product which included the claim Libido Boost for him, and similar claims to the Naturopathica advertisement such as Improve sex drive, stamina and endurance, circulation, as well as a heading General Information with the wording Horny Goat Weed is a potent formulation that incorporates concentrated dosages of the herbs traditionally used throughout the world to enhance libido and support female & male sexual function. Page 2 of 10

3 The product(s) 5. The advertisement promoted Horny Goat Weed for Him (AUST L ). The advertiser(s) 6. The advertisers were the sponsor of the product, Pharmacare Laboratories Pty Ltd, and Pharmacy Online. The complaint^ 7. The complainant requested anonymity. 8. The complainant alleged that the advertisements included claims that were in breach of the regulations, and provided the following summary of the breaches of sections 4(2)(a), 4(2)(c), and 4(2)(d) of the Code: Aphrodisiac A high potency formulation Medically recognised ingredients proven by modern medical research Help increase peripheral circulation, stamina and endurance Encourage and support the body s natural drives and desires and;.enhance libido and support.male sexual function 9. The complainant also alleged that indications included in the public ARTG summary were in breach of sections of the Therapeutic Goods Advertising Code. However, as this does not fall within the jurisdiction of the Panel, the Panel was unable to consider this aspect of the complaint. 10. In support of their argument, the complainant set out A summary of the key scientific evidence for &/or against with articles attached. The summaries related to several references, which had been reviewed and listed by the complainant, but no copy of any paper to which reference was made was provided. 11. The complainant stated Searching the Cochrane library s CENTRAL database yielded no relevant clinical trials involving Epimedium and erectile dysfunction. The complainant also searched Ovid Medline for this ingredient and for tribulus terrestris. The search resulted in a study in rats (epimedium) and, of five references found for tribulus terrestris, one relevant study ( Tribulus terrestris versus placebo in the treatment of erectile dysfunction: A prospective, randomized, double blind study by Santos Jr et al), a small clinical trial. 12. The complainant commented Of the limited number of trials found in regards to the efficacy of T. terrestris, this trial is the most controlled. and However, results from this trial do not support Naturopathica s reasoning behind including this ingredient in their product, and most importantly, the claim that is has been proven by modern medical research. Their claim that the product will encourage and support the body s natural drives and desires is based on historical views that suggest T. terrestris will increase serum testosterone. Such claims are unjustified and, ironically, been proven by medical research to not occur. Page 3 of 10

4 Additional matters raised by the Panel 13. 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 additional matters possible breaches of: Section 22(5) of the Act because the advertisements may be advertising the product for an indication other than the indications accepted in relation to the inclusion on the Register Sections 4(1)(b) and 4(4) of the Code in relation to the claim proven by modern medical research Section 5(2) of the Code because of references to sexual dysfunction and impotence The advertisers responses to the complaint^ 14. As the advertising claims included on the website were substantially the same the sponsor s advertising, the Panel did not seek a response from Chemist Warehouse as it appeared that the sponsor was apparently responsible for the claims. 15. However, the Panel did seek a response from Pharmacy Online as some of the claims included on the website differed from the sponsor s advertising. Pharmacy Online 16. Pharmacy Online stated I have immediately removed all product advertising. The product information was provided by our supplier, Pharmacare (and I believe owns the company that is the sponsor of this product). Standard practice for suppliers who work with our business must advise us if product information and/or advertising changes or is in breach of the Advertising Code., and said that the complaint had been forwarded to PharmaCare for their response. Sponsor/advertiser PharmaCare Laboratories 17. PharmaCare Laboratories response addressed the advertising by PharmaCare on the website as well as the Third Party retailers, i.e. the Pharmacy Online and Chemist Warehouse website advertisements. 18. PharmaCare noted that Pharmacy Online has removed the claims that were alleged to have breached the Code, and stated we are unaware of how this third party retailer had received the above content. and provided some amended copy. 19. In relation to the Chemist Warehouse advertisement, PharmaCare noted the claims alleged to breach the Code, and stated they have advised Chemist Warehouse to insert new website copy for the product, a copy of which was provided to the Panel. 20. In relation to their own Naturopathica website, PharmaCare stated that they have now amended the website copy on the Naturopathica website for the product and provided the Panel with a copy of the amended claims, concluding that Since the website amendments have been made, we are therefore of the view that we are not in breach of sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d), 4(4) and 5(2) of the Therapeutic Goods Advertising Code Page 4 of 10

5 21. In addressing the complainant s allegation of there being insufficient evidence associated with two of the primary ingredients within the product, and the following claims: Epimedium sagittatum (Horny Goat Weed): a high potency formulation, proven by modern medical research and helps increase peripheral circulation, stamina and endurance. Tribulus terrestris (Surra Gokhru): proven by modern medical research and encourage and support the body's natural drives and desires., PharmaCare stated We would like to advise that we are putting forward traditional evidence to support the therapeutic claims associated with Horny Goat Weed and Tribulus terrestris. The complainant has evaluated the scientific evidence for only two ingredients of this product, including Horny Goat Weed and Tribulus terrestris. However at no point on our ARTG listing, packaging or brand website have we made claims regarding medical, scientific or clinical research as this was listed in error on the Pharmacy Online website. This content has been removed and we are not sure where the retailer had received this content from. Apart from the claims regarding modern research, the rest of the claims are substantiated by specific ingredients in the product based on majorly traditional research. PharmaCare gave as an example: Ginkgo for peripheral circulation Siberian Ginseng and Korean Ginseng for stamina and endurance Horny Goat Weed and Tribulus terrestris for libido and desire 22. PharmaCare noted that the claims proven by modern medical research and Encourage and support the body s natural drives and desires have been removed from the Pharmacy Online website and stated in conclusion that they are strongly of the view that we are not in breach of the following sections of the Therapeutic Goods Advertising Code 2015, 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d), 4(4), 5(2) since we have clearly identified that the amended advertising copy is referring to that of the majorly traditional use of the product s primary herbal ingredients and nutrients. In addition, again, Pharmacy Online has since removed the incorrect website content that was listed in error. 23. PharmaCare provided a copy of a Substantiation Evidence Summary from the ARTG listing as well as a substantial number of papers. No index, summary, rationale for their inclusion or explanation was provided as to how the materials substantiated any of the claims. Findings of the Panel preliminary matter 24. The Panel notes for the benefit of the advertiser and the readers of this determination that since the Panel s inception, sponsors and advertisers have been informed about the regulatory requirements for the advertising of therapeutic goods to the public and the remit of the Complaints Resolution Panel. That is, the Panel must receive, consider and determine complaints about a particular advertisement(s) that has been published or broadcast on a specific date in specified media. The findings, therefore, can relate only to the advertisement that is the subject of the complaint at the time the complaint was made. Page 5 of 10

6 25. The Panel, therefore, is unable to make any finding whatsoever about revised or amended claims, such as those set out by PharmaCare in their response. section 22(5) of the Act 26. Section 22(5) of the Act states that advertisements for therapeutic goods must not, by any means, advertise the goods for an indication other than those accepted in relation to the inclusion of the goods in the Register. 27. The Panel noted that neither sexual dysfunction nor impotence were entered on the Register as an indication for this product. 28. The Panel found, therefore, that this aspect of the complaint was justified. sections of the Code alleged to have been breached. 29. Section 4(1)(b) of the Code requires that advertisements for therapeutic goods contain correct and balanced statements only and claims which the sponsor has already verified. Section 4(2)(a) of the Code prohibits representations that are likely to arouse unwarranted and unrealistic expectations of product effectiveness. Section 4(2)(c) of the Code prohibits representations that mislead directly or by implication or through emphasis, comparisons, contrasts or omissions. 30. Having reviewed the materials provided, the Panel was satisfied that: the advertiser did not provide clear commentary setting out the relevance of the material or the manner in which any ingredient or medicine to which the material related were comparable to the advertised product. No attempt had been made to explain the reason for the inclusion of, or the relevance of, the supporting materials other than their broad support for traditional use claims. No scientific or medical evidence was included. the material appeared to be mostly extracts from text books the material provided was by no means sufficiently robust scientifically to support claims such as treat factors that cause sexual dysfunction, lifts libido levels, increases energy, stamina and endurance, circulation and decreases stress, high potency formulation and the representations: o Natural alternative. Avoid Viagra, hormone replacement or implanted medical devices. o Helps tackle the cause of impotence. It can help with the physiological factors causing impotence, such as fatigue, poor circulation and loss of libido. o Medically recognised ingredients: It combines the most effective natural aphrodisiacs used traditionally over thousands of years and proven by modern medical research. 31. As a consequence, the Panel found that the claims were unverified, were likely to arouse unwarranted and unrealistic expectations of the product s effectiveness and were misleading in breach of sections 4(1)(b), 4(2)(a) and 4(2)(c) of the Code. The Panel also noted the undertakings given by PharmaCare and Pharmacy Online as to the actions taken to rectify the content of the advertisements. 32. The Panel found, therefore, that these aspects of the complaint were justified. Page 6 of 10

7 33. Section 4(2)(d) of the Code prohibits advertisements which abuse the trust or exploit the lack of knowledge of consumers or contain language which could bring about fear or distress. 34. The Panel was satisfied that the unsubstantiated claims were likely to abuse the trust and exploit the lack of knowledge of consumers in breach of this section of the Code. 35. The Panel found, therefore, that this aspect of the complaint was justified. 36. Section 4(4) of the Code requires scientific information to be presented in a manner that is accurate, balanced and not misleading, requires scientific terminology to be appropriate, clearly communicated and able to be readily understood by the audience to whom it is directed and requires that publication of scientific research results should identify the researcher and financial sponsor of the research. 37. Given the findings with respect to the lack of substantiation for the claims of benefit and the lack of identification of any research or financial sponsor of any research involved in the claim proven by modern medical research, the Panel was satisfied of a breach of section 4(4) of the Code. 38. The Panel found, therefore, that this aspect of the complaint was justified. 39. Section 5(2) of the Code prohibits advertisements that refer, expressly or by implication, to serious forms of diseases, conditions, ailments or defects specified in Part 2 of Appendix 6, unless prior approval is given under the Therapeutic Goods Act The diseases and conditions specified in Part 2 of Appendix 6 of the Code include serious forms of a wide range of health concerns. 40. The Panel noted that claims about sexual dysfunction (including impotence ) in the Pharmacy Online advertisement had not been included on the Register for this product. Because the claim could include many different types of conditions requiring diagnosis and treatment by a healthcare professional, the claim constitutes a restricted representation for which prior approval is required before its inclusion in any advertisement directed to consumers. The Panel was satisfied that no such approval and been sought or obtained and that, therefore, the Pharmacy Online advertisement breached section 5(2) of the Code. 41. The Panel found, therefore, that this aspect of the complaint was justified. 42. The Panel noted, without making any formal finding, that the Pharmacy Online advertisement was also likely to breach section 42DL(1)(f) of the Act by including a reference to prescription products, namely Viagra and hormone replacement therapy. Sanctions 43. The Panel requests Pharmacare Laboratories Pty Ltd and Pharmacy Online in accordance with subregulation 42ZCAI(1) of the Therapeutic Goods Regulations 1990: a) to withdraw the advertisements from further publication; b) to withdraw all the representations noted above as having breached the Act and Code, including any restricted representation; c) not to use the representations in (b) above in any other advertisement*; Page 7 of 10

8 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; 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. 44. 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 21 June 2017 For the Panel Allan Asher Chairman Page 8 of 10

9 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 9 of 10

10 Appendix B: Excerpt of the Advertisement Page 10 of 10