Code sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(e)(ii) Withdrawal of advertisement. Withdrawal of representations

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1 COMPLAINTS RESOLUTION PANEL DETERMINATION Complaint Fertility Formula Male ARTG ID: AUST L Meeting held 17 November 2016 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 Mygen Health Pty Ltd Internet advertisement Final Act section 42DM(1) Code sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(e)(ii) Act section 22(5) Withdrawal of advertisement 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 11

2 The advertisement(s)^ 1. The complaint concerned an internet advertisement published at the website viewed by the complainant in September The advertisement comprised a product page from the website, which included the heading fertility formula male, the wording Planning to conceive? Supporting healthy sperm production., a pack shot of the product, adjacent pricing, product description and dosage, as follows: Description Contains 17 therapeutically active ingredients including: Vital nutrients Antioxidants CoQ10 Selenium Zinc 90 day supply (3 packs of 30 day supply). There are 30 tablets and 30 capsules in each pack. 90 tablets and 90 capsules in total. This comprehensive formula uses quality forms and therapeutically active levels of ingredients. Designed specifically for the fertility needs of men, the formula: Is essential for quality sperm production and sperm count in healthy men Has an essential role in cellular activity Maintains and supports the health of the prostate Supports healthy male hormone function Supports stamina and endurance Dosage Adults take 1 capsule daily with your morning meal and 1 tablet daily after your morning meal or as directed by your healthcare professional. Taking supplements with meals may assist absorption. As it takes 119 days for sperm maturation, it is recommended that men start taking this formula 3 to 4 months prior to conception. The active ingredients were listed and warnings included, per the screen shot extract from the advertisement below. Page 2 of 11

3 3. An excerpt of the advertisement can be viewed in the relevant Appendix to this determination. The product(s) 4. The advertisement promoted Fertility Formula Male (AUST L ). The advertiser(s) 5. The advertiser was Mygen Health Pty Ltd. The complaint^ 6. The complainant requested anonymity. 7. The complainant alleged the following breaches of the Act and the Code: Act sections 22(5) and 42DM(1) Code sections 4(1)(b), 4(2)(a), 4(2)(c) and 4(2)(e)(ii) 8. The complainant stated that MyGen Health claims that the included ingredients are at therapeutically active levels needed for Essential for quality sperm product and sperm count in healthy men. Specifically, MyGen claims in both its website as well as its ARTG public summary that zinc, selenium, folate, coenzyme Q10 and Vitamins A, E and C in particular are needed for a range of male reproductive functions and Therapeutic activity together with strong wording such as essential indicates that the activity of each of these ingredients should have a strong, clinically significant, evidential basis in humans. Additionally the population of healthy men does not relate to current evidence, which is only tested in infertile men. 9. The complainant presented a summary of the key scientific evidence having searched Medline for any articles containing some key words such as Dietary supplements OR Nutraceuticals AND male fertility, virility or sperm in humans, then filtered for by title so English titles remained. The evidence behind the seven key ingredients mentioned above in improving male reproductive function were filtered from the search and examined. Page 3 of 11

4 10. The complainant described study findings and noted the following conclusions with respect to the seven key ingredients Zinc Zinc therapy in the treatment of infertility has been additionally validated by followup studies, and appears beneficial. However, current evidence is restricted to zinc s effect in infertile men only, a qualification MyGen has not put in their advertising. Selenium although the most recent and largest RCT has found selenium efficacious in improving semen, the study population was limited to infertile men and thus, cannot be generalized to MyGen s claim of healthy men Folate In the light of the weaker earlier studies and later, an RCT, there is very little evidence of a clear relationship between folate levels and sperm count. Research was also primarily conducted in infertile men which limits generality CoEnzyme Q10 Overall, conenzyme Q10 may in fact have an effect on semen quality in infertile men. However, there are doubts there is any therapeutic effect at the 100mg/day dose MyGen indicates. Vitamin A Overall, there is only very weak evidence that Vitamin A protects sperm against oxidative stress. Vitamin E There is weak evidence that vitamin E may play a role in protecting against oxidative stress. However, there is no evidence directly investigating the role Vitamin E plays in male fertility. Vitamin C Overall, the evidence regarding Vitamin C s role in sperm quality is conflicting. Evidence from well designed RCT does exist that support the notion that Vitamin C may have a protective effect on sperm count and quality. However, as above, the vast majority of research has focused on infertile men and not on healthy men as MyGen s claims have targeted. 11. The complainant summarised the claims made by MyGen lack evidence when discussing healthy males. It would be reasonable to conclude from our research that although some ingredients are relevant to sperm quality and count, supplementation of the ingredients found in the fertility formula are really only relevant in cases of infertility or deficiency. The advertiser s response to the complaint^ 12. A response to the complaint was provided by Advanced Wellness Regulatory Solutions, acting on behalf of the sponsor/advertiser, MyGen Health Pty Ltd. 13. The respondent included with the response a letter which raised certain issues under the section 44 of the CRP Procedures document and part 42ZB of the Therapeutic Goods Regulations relating to conflict of interest obligations. Further, the advertiser raised concerns about confidentiality of material submitted in the complaints process and sought that a named Panel member (Choice nominee) be excluded from the review process. 14. A vast quantity of evidence material to support the claims was provided with the response, much of which was not directly relevant to the complaint. A lengthy evidence summary table (more than 220 pages), with some sections highlighted, and some complete papers and monographs were provided. The respondent also provided a copy of correspondence with the Listing Compliance Unit of the TGA with respect to specific and non-specific indications. Page 4 of 11

5 15. The respondent stated In response to the use of the term therapeutic activity, despite the fact that the ingredients being referred to are in the product at therapeutic levels for various body processes, as per the evidence summaries attached, any reference to this has been removed from the website. As the ingredients are at therapeutic levels reported in various acceptable evidence based texts to have a variety of positive health effects in the body, we do not agree that this statement is in breach of the Therapeutic Goods Advertising Code. We have supplied at least one piece of evidence for each ingredient to show that the levels of the ingredients within the product are at therapeutic levels as per suitable evidence to support the usage of the ingredients. 16. The respondent referred to the correspondence with the TGA regarding use of biomarkers and expressed some confusion about advice as to the use of the term in healthy individuals. 17. The Panel was informed that amendments to the following claims have been made in response to the complaint: Mygen Health s Fertility Formula for men is a specialised reproductive nutritional supplement to Mygen Health s Fertility Formula for men is a specialised formula to support male reproductive health ; Contains 17 therapeutically active ingredients to Contains 17 active ingredients including, and This comprehensive formula uses quality forms and therapeutically active levels of ingredients. Designed specifically for the fertility needs of men, this formula to This comprehensive formula uses quality forms of active ingredients. Designed specifically for the normal fertility needs of men, this formula includes ingredients that: Is [Are] essential for quality sperm production and sperm count in healthy men, Has [Have] an essential role in cellular activity, Maintain[s] and support[s] the health of the prostate, Support[s] health male hormone function, Support[s] stamina and endurance. 18. The respondent stated that the effect of amending the above claims was that the implications of the claims becomes non-specific structure/function type claims. This includes the use of the word essential to imply that the nutrients are essential nutrients required for various processes within the body and referred the Panel to the evidence provided to support these structure/function statements of fact that are made in the advertisement. Findings of the Panel preliminary issues raised by the advertiser 19. The respondent included with the response a letter which raised certain issues under the section 44 of the CRP Procedures document and part 42ZB of the Therapeutic Goods Regulations relating to conflict of interest obligations. Further, the advertiser raised concerns about confidentiality of material submitted in the complaints process and sought that a named Panel member (a Choice nominee) be excluded from the review process. 20. The Panel considered the advertiser's request concerning conflict of interest and confidentiality in the context of the Therapeutic Goods Regulations 1990 and the Panel's Procedures and was satisfied that the matter could be discussed at this meeting. It notes the following for the benefit of the advertiser and the readers of this determination: Page 5 of 11

6 Regulations applying to the Panel The Complaints Resolution Panel (and its members) are bound by the Therapeutic Goods Regulations and the CRP Procedures document (a copy of which is provided to parties to any complaint), to ensure the highest level of probity in the discharge of its functions. This includes meticulous attention to issues of conflict of interest obligations of Panel members and confidentiality. Composition of the Panel The Complaints Resolution Panel is an example of a partnership between government and nongovernment stakeholders to exercise controls. The membership of the Panel consists of representatives from industry, consumers, healthcare professionals and government. It is chaired by a person nominated by the Therapeutic Goods Advertising Code Council. The Panel is part of a system of advertising arrangements for therapeutic goods designed to ensure public health and safety while allowing a dynamic and fair environment for the manufacturing of products. These arrangements control promotional messages and general information about products to the public and are in place to ensure that all communications are truthful, valid and not misleading, such as by making unverified representations, arousing unwarranted expectations or downplaying possible risks. The long-term strength of the Panel derives from the strong commitment from government, industry and non-government stakeholders to providing skilled and dedicated representatives. A diversity of views, skills and experiences amongst Panel members contributes to well-rounded decisions. Panel members engage in respectful debate on the merits of complaints against the provisions of the relevant laws, regulations and procedures. Conflict of interest obligations In relation to conflict of interest obligations, the regulations and procedures refer to a member who has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting The Panel is of the view that to preclude a member from participation in a decision, the conflict must relate to the matter to be determined. At the beginning of each Panel meeting members are called on to make disclosures and where the Panel determines, is excluded from all discussion of the matter in question. It should be noted that an actual conflict of interest is just one of three possible areas of concern. Apparent and Potential Conflicts of Interest are also matters which need to be considered. Confidentiality The Procedure for Complaints about Advertisements (and/or Generic Information) for Therapeutic Goods that are directed to Consumers in Specified Media, published 3 December 2015 (the Procedure), includes strong confidentiality provisions at paragraphs 41 and 42. The Procedure requires Panel members (and others) to observe complete confidentiality in relation to all information concerning the deliberations of the Panel. It should be noted that after the Panel s final written determination has been communicated to the known parties to a complaint and made available to the public, Panel members, observers Page 6 of 11

7 and the Panel secretariat may educate and inform the public about the general principles arising from the determination and may participate in public discussion of the procedures of the Panel. As well, it should be noted that the regulations allow for a representative organisation of the Panel to nominate an alternative person to attend any Panel meeting in the absence of the nominee. alleged breaches of the Act and the Code 21. Section 22(5) of the Act states that advertisement 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. 22. The Panel was satisfied that the complainant had not identified or specified a claim in the advertisement that had not been included as one of the list of indications in the Register. 23. The Panel found, therefore, that this aspect of the complaint was not justified. 24. 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. 25. The Panel considered the claims Contains 17 therapeutically active ingredients, This comprehensive formula uses quality forms and therapeutically active levels of ingredients. Designed specifically for the fertility needs of men, the formula Is essential for quality sperm production and sperm count in healthy men Has an essential role in cellular activity 26. The Panel noted that the target audience for this listed product could not be male populations of sub/infertile men, which were the subject of some of the evidentiary material, as these are serious conditions. 27. The Panel formed the view that much of the evidence provided appears to be reasonable and adequate for general male reproductive health support, in terms of the product containing vitamins and minerals used in the production of sperm. However, the references to quality sperm production and sperm count are biomarkers that are different from general reference to the production of sperm (a supportive function) and takes the representation essential for quality sperm production and sperm count to the level of implied references to infertility or subfertility and an implication that the product is efficacious for these conditions. A similar view was taken with respect to the claim has an essential role in cellular activity. 28. The Panel s overall view of the evidence provided was that it was mainly textbook-based general-level evidence and, while voluminous, was poorly linked to the complaint made. 29. The TGA response regarding biomarkers clearly stated that the overall context is critical when evaluating claims. In this instance, the Panel was of the view that the claims in the advertisement about which the complaint was made were not simple structure-function claims but implied that the product is essential for quality sperm production and sperm count in healthy men, and were made in the context of the statement as it takes 119 days for sperm Page 7 of 11

8 maturation, it is recommended that men start taking the formula 3 to 4 months before conception. 30. The Panel was satisfied that these claims for this product, in the context of the advertisement as a whole, were neither correct nor balanced, that the strength of the claims were inappropriate for this product and had not been supported by the materials provided, in breach of section 4(1)(b) of the Code. 31. The Panel also was satisfied that the claims appeared to imply that the product will have a beneficial effect on fertility in healthy men, whereas the evidence provided was general and supportive only, and, therefore, were likely to arouse unwarranted and unrealistic expectations of product effectiveness, in breach of section 4(2)(a) of the Code. 32. The implication made in the advertisement that normal healthy men may have difficulty in conceiving and that this product is essential or would serve as an important aid to achieving conception, and because it has not been demonstrated that the product is essential for quality sperm production or sperm count in healthy men, the Panel was satisfied that the advertisement was misleading, in breach of section 4(2)(c) of the Code. 33. The Panel found, therefore, that these aspects of the complaint were justified. 34. Section 4(2)(e) of the Code prohibits representations that are likely to lead persons to believe that they are suffering from a serious ailment or that harmful consequences may result from advertised products not being used. 35. The Panel formed the view that the wording is essential for quality sperm production and sperm count in healthy men was likely to cause persons to believe that harmful consequences may result from not using the product, in breach this section of the Code. 36. The Panel found, therefore, that this aspect of the complaint was justified. 37. Section 42DM(1) of the Act requires advertisements for therapeutic goods to comply with the Code. Because of the breaches already noted, the Panel found that this aspect of the complaint was justified. 38. In drawing attention to the fact that the respondent provided amended wording for claims as part of the response, the Panel notes that it has no role in relation to reviewing amended advertising claims for use in future advertising. Sanctions 39. The Panel requests MyGen Health 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 all the representations noted above as having breached the Act and Code, including any reference to the product being essential for quality sperm production and sperm count; 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 Page 8 of 11

9 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. 40. 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 30 March 2017 For the Panel Allan Asher Chairman Page 9 of 11

10 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 10 of 11

11 Appendix B: Excerpt of the Advertisement Page 11 of 11