Code sections 4(1)(b), 4(2)(a), 4(2)(c) No sanction undertakings accepted

Transcription

1 COMPLAINTS RESOLUTION PANEL DETERMINATION Complaint Blackmores Bilberry Eyestrain Relief ARTG ID: AUST L Meeting held 15 December 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 Blackmores Limited Internet advertisements Final Code sections 4(1)(b), 4(2)(a), 4(2)(c) Code section 4(2)(h) No sanction undertakings accepted * 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 8

2 The advertisement(s)^ 1. The complaint concerned internet advertisements published on the websites and viewed by the complainant on 29 August The Blackmores website advertisement included the representations Blackmores Bilberry Eyestrain Relief is formulated to support visual acuity and Eye strain and fatigue is often caused from fine detailed work, computer work, poor night vision or glare sensitivity. The advertisement also included the heading Why use followed by the dot points: Helps to maintain visual sharpness in poor light (night vision) Supports healthy functioning of the retina May help strengthen the walls of the many small capillaries that help nourish the eye (microcirculation) 3. The Chemist Warehouse and Pharmacy Direct website advertisements included similar representations about the advertised product, such as Daily computer use, night driving and fine detail work can lead to symptoms of eyestrain, Bilberry has traditionally been used to relieve eyestrain, eye fatigue, weariness as well as support night vision, The active compounds in Bilberry work to help strengthen microcirculation and blood vessels in the eye, Helps maintain visual acuity and sharpness in poor light, Supports healthy functioning of the retina and may help reduce the risk of damage to the microcirculation of the eye and The anthocyanosides in bilberry help to maintain visual acuity (sharpness) and improve night vision. 4. An excerpt of the advertisement can be viewed in the relevant Appendix to this determination. The product(s) 5. The advertisement promoted Blackmores Bilberry Eyestrain Relief (AUST L ). The advertiser(s) 6. The advertiser was the sponsor of the product, Blackmores Ltd. The complaint^ 7. The complainant requested anonymity. 8. The complaint alleged that the following representations were in breach of sections 4(1)(b), 4(2)(a), 4(2)(c) and 4(2)(h) of the Code: Bilberry has traditionally been used to relieve eyestrain, eye fatigue and eye weariness Helps maintain visual acuity and sharpness in poor light Supports night vision Page 2 of 8

3 The anthocyanosides in bilberry help to maintain visual acuity and sharpness in poor light (night vision) 9. The complainant provided A summary of the key scientific evidence for &/or against the claims raised in the complaint. The summary was set out in 2 parts. 10. Part 1 of the evidence summary related to the representations that bilberry has traditionally been used to relieve eyestrain, eye fatigue and eye weariness, with the complainant noting that these claims should be substantiated by scientific research. 11. The complainant advised that their search of PubMed and MEDLINE revealed a recent study by Ozawa et al (2015), and provided a copy of the study. The complainant noted that the final comment in the study was further information is required on the application of BE as a common intervention therapy for reducing eye fatigue in VDT workers, this study may contribute to understanding the wider effects of BE. and surmised that This not only highlights that the research is essentially inconclusive and that bilberry extract shouldn t be used as a medical intervention without further research. The complainant also noted that this study was published in November 2015 and that the advertised product was listed in the Register prior to this (mistakenly noting 2005 instead of the correct year, 2008). 12. The complainant also argued that The ambiguity in results was also confirmed by a 2007 review carried out by Gosh and Konishi, whereby the older and less rigorous studies presented with positive correlations between bilberry extract/anthocyanosides and improved eye function, whereas, recent and more credible studies showed little to no causative relationship. Similarly a 2004 review conducted by Canther and Ernst supported the latter need for further research in this medical field. 13. Part 2 of the evidence summary related to the representations that the product helps maintain visual acuity and sharpness in poor light, supports night vision and that the anthocyanosides in bilberry help to maintain visual acuity and sharpness in poor light, with the complainant noting that these claims should be verified by readily published evidence. 14. The complainant advised that their search of PubMed revealed a study by Zadok et al (1999), and provided a copy of the study. The complainant noted that the authors concluded that Multiple oral administrations of 12 and 24mg anthocyanosides twice a day appear to lack significant effects on night vision tests. and argued that It is important to note that there was no studies found on the positive correlation between anthocynanoside dosage and night vision improvement. Therefore the claims made by the sponsor are questionable and potentially unjustified. 15. In relation to Zadok et al (1999), the complainant noted that: The number of patients used in the study was small There were no significant differences between the anthocyanoside treated groups and the control group during the 4 day drug administration period The author encourages that further testing be conducted using a longer period of drug administration and a larger number of participants. It is important to note that no recent studies have been conducted on the effects of anthocyanosides on night vision. Page 3 of 8

4 The dosages used in Zadok s study were 12/24mg administered twice a day daily. That is a maximal dose of 48mg per day. This is synonymous with the maximal dose of anthocyanosides found within Blackmores Bilberry (48.6mg) should three capsules be taken per day. As it was proven in this study that 48mg is not sufficient enough to see improvements in night vision. Blackmores cannot justify the effects of anthocyanosides on night vision. 16. The complainant also advised that A PubMed search was conducted to see if another group had replicated the results of this study and an earlier study was found examining the effects of anthocyanosides on night vision in Levy and Glovinsky (1998) found that single oral administrations of 12-36mg of anthocyanosides appear to lack significant effects on military relevant night vision. 17. The complainant concluded We believe that the sponsor Blackmores has made claims about the effects of Bilberry/anthocyanosides that are not supported by scientific evidence. and We ask the TGACRP to request Blackmores to retract these unsubstantiated claims for these products; ensure that 3rd parties such as Internet pharmacies also correct their promotion (which was presumably sourced from the sponsor). 18. The complainant also alleged breaches in relation to some of the indications included in the Register for the advertised product. However, as the Panel is unable to consider indications in the Register, its consideration of the complaint was confined only to the representations made in the website advertisements. The advertiser was advised accordingly. The advertiser s response to the complaint^ 19. Blackmores provided its response in 2 parts, in line with how the complainant had set out the complaint and evidence summary. 20. In response to Part 1, the advertiser stated: Although the dates are confused, the complainant rightly points out that the study [Ozawa et al. (2015)] was published in 2015 yet Blackmores Bilberry Eyestrain Relief was listed on the ARTG in June 2008, with the most recent effective date as February At the time of listing the ARTG claims for the product were believed to be supported by traditional and textbook evidence. The complainant themselves points out a 2007 review identified positive correlations between bilberry extract/anthocyanosides and improved eye functions, whereas more recent studies suggest further research is required to fully understand the benefit. The receipt of this complaint has prompted us to review the current body of evidence for both traditional and scientific support of bilberry extract and claims around eyestrain, eye fatigue and eye weariness. Given the inconclusive scientific evidence that has been highlighted we agree that claims in relation to eyestrain are no longer adequately substantiated based on the current levels of evidence guidelines. We are now retracting product claims around eyestrain, eye fatigue and eye weariness and we have initiated the process to change the name of the product, a process which will be completed once the current stock of labels is exhausted. 21. In response to Part 2, the advertiser stated:..bilberry has a long history of use and at the time of listing it was believed there was evidence to support a traditional use relating to night vision and visual acuity in poor light. The notion that bilberry can be used to enhance night vision arose from anecdotal reports of British Royal Air Force (RAF) aviators in World War II eating bilberry jam to improve their night vision. In Page 4 of 8

5 addition to this, numerous studies since the 1960s further suggested a benefit of bilberry on night vision. As the complainant points out, recent scientific evidence to support the use of bilberry has not replicated a positive effect. Due to the difficulty in ascertaining the role of bilberry in improving night vision it is now generally recognised that further trials on the extract are warranted. We therefore also agree that claims in relation to night vision and visual acuity in poor light are unsupported based on the current levels of evidence guidelines. As above, we are voluntarily retracting product claims around night vision and are in the process of changing the name of the product, a process which will be completed once the current stock of labels is exhausted. 22. The advertiser concluded Blackmores confirms it is committed to ensuring the claims made in relation to our products are substantiated. We are now taking appropriate action to withdraw the representations for the product, which will include notifying our retail partners and updating the Blackmores website. The website has already been updated to remove claims around eyestrain and night vision, however the product name temporarily remains while we implement a label change to change the name of the product. 23. As part of its response, Blackmores also provided the Panel with the current ARTG summary for the advertised product and an updated ARTG application submitted with revised indications and new product name. Findings of the Panel 24. As a preliminary matter, the Panel noted that the representations made in the advertisements were substantially the same and that the retailer websites only included claims consistent with the sponsor s website and in line with the indications included in the Register for the advertised product. For this reason, the Panel was satisfied that the sponsor, Blackmores Ltd, was responsible for the advertisements. 25. 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. 26. The Panel noted the advertiser s response that older evidence was used for traditional use claims at the time of listing the product in the Register but that there is now more recent scientific evidence that doesn t support the representations raised in the complaint. The Panel noted that Blackmores agreed to remove the claims and change the product name and packaging, and that evidence of this was provided. 27. Based on the material before it, the Panel was satisfied that the following representations had not been verified, were not correct and balanced, were likely to arouse unwarranted expectations and were misleading, in breach of sections 4(1)(b), 4(2)(a) and 4(2)(c) of the Code: Bilberry has traditionally been used to relieve eyestrain, eye fatigue and eye weariness Helps maintain visual acuity and sharpness in poor light Supports night vision Page 5 of 8

6 The anthocyanosides in bilberry help to maintain visual acuity and sharpness in poor light (night vision) 28. The Panel found, therefore, that these aspects of the complaint were justified. 29. 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. 30. The Panel did not find any words in the advertisement that implied that the advertised product would be effective in all cases of a condition. 31. The Panel found, therefore, that this aspect of the complaint was not justified. Sanctions 32. Given the undertakings provided by Blackmores Limited, the Panel decided to apply no sanction. Dated 28 April 2017 For the Panel Allan Asher Chairman Page 6 of 8

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 7 of 8

8 Appendix B: Excerpt of the Advertisement Page 8 of 8