The Complainant said the claims were misleading as The overall scientific literature doesn t show that Arnica helps the body.

Transcription

1 COMPLAINT NUMBER COMPLAINANT ADVERTISER ADVERTISEMENT D. Ryan Pharmacy Direct Pharmacy Direct Website DATE OF MEETING 11 October 2016 OUTCOME Not Upheld in part / Settled in part SUMMARY The website advertisements on Pharmacy Direct ( were for a range of different Arnica products. The products included Artemis Tissue Repair Sports Cream, Skybright Arnica Liniment Spray, Naturo Pharm Arnica Plus Cream, Naturo Pharm Arnica Extra Strength Gel, Naturo Pharm Arnica Cream and Naturo Pharm Arnica Lotion. These products made claims about the effectiveness of Arnica. The Complainant said the claims were misleading as The overall scientific literature doesn t show that Arnica helps the body. The Complaints Board noted that the Advertisers and the Media had amended the wording on the website so that the claims relating to the benefits of the various products were now low level claims that had been supported. The Complaint Board ruled the Complaint was Not Upheld in part and Settled in part. [No further action required] Please note this headnote does not form part of the Decision. COMPLAINTS BOARD DECISION The Chair directed the Complaints Board to consider the advertisements with reference to the Therapeutic Products Advertising Code, Principles 2, 3 and Part B1 Requirements 3,4 and 4(a). The Complaints Board ruled the complaint was Not Upheld in part and Settled in part. The advertisements subject to complaint were on the Pharmacy Direct website. In their response, Pharmacy Direct said Manufacturer product information is sourced from product packaging, product fact sheets, and the manufacturers website if they have one. Pharmacy Direct also said As a result of this complaint we reviewed the products quoted and have found that some changes in these products had not been notified to us so we will be addressing that issue with these manufacturers directly to remind them of the process they are meant to be following. However we have refreshed the content of all of these products to reflect the current content as can be found on the manufacturers websites and I would hope this addresses the issues raised.

2 The advertisements subject to complaint were different companies and related to different products. The Complaints Board dealt with each individual product separately. Skybright Arnica Liniment Spray The Advertisement for Skybright Arnica Liniment Spray said in part Arnica has been researched extensively and is well known for its healing properties. High potency natural calming & healing cream Aids healing & mobility and Soothes muscles and tired joints and helps with general muscle function. It also can be beneficial for people who are bedridden or disabled, when applied as a soothing muscle rub. The Complainant said this advertisement was misleading as The overall scientific literature doesn t show that Arnica helps the body. The Advertiser, Skybright, had reviewed its advertisement and changed the wording to read Specially formulated to assist the body s natural healing ability before and after exercise. Soothes muscles and tired joints and helps with general muscle function. The Complaints Board considered both the original and changed wording. The Complaints Board agreed that the original wording in the advertisement made very low level claims of support and said the research available supported the use of Arnica for the purpose advertised. Therefore the Complaints Board ruled the complaint in relation to Skybright Arnica Liniment Spray was Not Upheld. Artemis Tissue Repair Sports Cream The advertisement for Artemis Tissue Repair said assisting the body's natural response to shock, injury, fatigue and bruising aids normal muscle recovery after strenuous exercise or exertion. Aids normal defence mechanisms in times of trauma and after surgery. Commonly used to help the body respond to trauma injuries and shock. Great for bruising, sprains, swelling and other superficial muscle and tissue injuries. Also good for joint mobility and suppleness. The Complainant said the claims in the advertisement could not be substantiated. In its response, the Advertiser, Artemis said in part: As an active herbal product, Arnica is a much researched herb. It has a wellestablished empirical evidence base in the treatment of trauma injuries (e.g. bruises, sprains and fractures) and rheumatic conditions that produce muscular pain and joint stiffness. Arnica is endorsed for the treatment of these conditions by many international regulatory bodies and herbal authorities including the European Medicines Agency, the World Health Organisation, Health Canada, the German Commission E and the European Scientific Co-operation on Phytotherapy. The Complaints Board was advised the wording in the advertisement for this product had been changed and now states: This powerful sports cream combines traditional plant medicine to support quick recovery for muscles. Tissue Repair Cream is effective in repairing and rebuilding tissue. Effective for post surgery, bruising, sports injuries or everyday sprains and strains. For deep-seated strains, use Strain Repair Cream - the same powerful formula but with the added benefit of warming Cayenne. Combine with Tissue and Strain Repair Oral Liquid to support healing from within. Recover quickly with Tissue Repair Cream. 2

3 Artemis also provided information in support of its advertising about the use of arnica and noted its use of the pre-vetting service for the wording in its product listings. The Complaints Board reviewed the original advertisement and the amended version and agreed the amended advertisement made lower level claims in line with the evidence provided about the use of arnica. Taking into account the action taken by the Advertiser to comply with the Therapeutic Products Advertising Code, the Complaints Board ruled the complaint about the Artemis Tissue Repair Sports Cream be Settled. Naturo Pharm Naturo Pharm had four products advertised on the Pharmacy Direct website. Naturo Pharm Classical Arnica Cream Naturo Pharm Classical Arnica Extra Strength Gel Naturo Pharm Classical Arnica Plus Cream Naturo Pharm Classical Arnica Lotion The wording in the advertisements included Assisting the body s natural response to shock, injury, fatigue and bruising. Aids normal muscle recovery after strenuous exercise or exertion Aids normal defence mechanisms in times of trauma and after surgery. Commonly used to help the body respond to the trauma injuries and shock Great for bruising, sprains, swelling and other superficial muscle and tissue injuries. Also good for joint mobility and suppleness. The Complainant said the advertisements for the Naturo Pharm products made strong therapeutic claims and needed to be substantiated. In response, the Advertiser, Naturo Pharm advised that the wording for its products on the Pharmacy Direct website included additional information that was not sourced from it. Naturo Pharm confirmed the wording on the Pharmacy Direct website for the products subject to complaint had been revised to match the wording from its own pre-vetted website. The new wording included: Arnica plus Cream is a Naturo Pharm Classical plus product that assists rapid response to bruising, fatigue, injury, shock and trauma and aids natural muscle recovery after strenuous exercise or exertion. Arnica plus is also available in a convenient oral spray form. Arnica Extra Strength Gel assists normal muscle recovery after strenuous exercise or injury. Its special gel base allows it to penetrate quickly into the skin giving maximum absorption of the higher strength Arnica tincture Arnica Lotion assists the body s natural response to shock, injury, fatigue and bruising and aids normal muscle recovery after strenuous exercise or exertion. Diluted with water, it is ideal to be used as a wet compress that can be left on overnight under a loose elastic bandage. 3

4 Arnica Cream is a Naturo Pharm product that assists rapid response to bruising, fatigue, injury, shock and trauma and aids natural muscle recovery after strenuous exercise or exertion. Arnica plus is also available in a convenient oral spray form. Naturo Pharm also provided information in support of its advertising about the use of arnica and noted its use of the pre-vetting service for its own website. The Complaints Board agreed the action taken by the Advertiser to amend the wording for the four products in front of it meant that the complaint in relation to this advertising was Settled. In the course of considering the complaints about each of the products the Complaints Board discussed the information provided by the advertisers in relation to the claims made about the products under the Therapeutic Products Advertising Code. The Complaints Board acknowledged there were different views about the efficacy of arnica. However, in the context of the low level claims made in the advertising before it, and taking into account the changes made, the Complaints Board agreed it was sufficient to rule that the complaint was Not Uphold in part and Settled in part. DESCRIPTION OF ADVERTISEMENT The website advertisements on Pharmacy Direct ( are for a range of different Arnica products. The products are Artemis Tissue Repair Sports Cream, Skybright Arnica Liniment Spray, Naturo Pharm Arnica Plus Cream, Naturo Pharm Arnica Extra Strength Gel, Naturo Pharm Arnica Cream and Naturo Pharm Arnica Lotion. All of these products are making claims around the effectiveness of Arnica. COMPLAINT FROM D. RYAN Pharmacy Direct breaks the Therapeutic Products Advertising Code Part B1 Requirement 3 for several of its Arnica products. The code states that advertisements must contain true and balanced claims. I'll list 4 products, but there are plenty of other products that have similar claims. The therapeutic claims being made are: Arnica (Arnica montana flos): Most effective first aid herb for impact injuries causing bruising, sprains, swelling, fractures and muscular and joint pain. Arnica is excellent after surgery to relieve trauma, swelling and pain. It stimulates circulation to the injured area and re-absorbs internal bleeding which accelerates healing. assisting the body's natural response to shock, injury, fatigue and bruising aids normal muscle recovery after strenuous exercise or exertion. Aids normal defence mechanisms in times of trauma and after surgery. Commonly used to help the body respond to trauma injuries and shock. Great for bruising, sprains, swelling and other superficial muscle and tissue injuries. Also good for joint mobility and suppleness

5 Sprain Away is a premium potency combination of NZ-grown Arnica and Comfrey. There is a wealth of evidence supporting the calming and healing action of these two herbs, and in combination, they provide proven natural support for strained muscles, sprains, stiff joints, bruises and sports injuries. Arnica has been researched extensively and is well known for its healing properties. High potency natural calming & healing cream Aids healing & mobility Soothes muscles and tired joints and helps with general muscle function. It also can be beneficial for people who are bedridden or disabled, when applied as a soothing muscle rub. The overall scientific literature doesn t show that Arnica helps the body. The review Systematic Review on the Efficacy of Topical Arnica montana for the Treatment of Pain, Swelling and Bruises concluded: The efficacy of Arnica in doses of 10% and below is not supported by the available evidence. More research is needed to determine if higher doses would be effective and remain safe. The review Efficacy of homeopathic arnica: a systematic review of placebo-controlled clinical trials concluded: The claim that homeopathic arnica is efficacious beyond a placebo effect is not supported by rigorous clinical trials. There is some evidence that it actually makes things worse. A paper concluded "Rather than decreasing leg pain, arnica was found to increase leg pain 24 hours after eccentric calf exercises. This effect did not extend to the 48-hour measurement." THERAPEUTIC PRODUCTS ADVERTISING CODE Principle 2 - Advertisements must be truthful, balanced and not misleading. Claims must be valid and have been substantiated. Principle 3 - Advertisements must observe a high standard of social responsibility. Part B1 Requirement 3 To assist consumers to make informed decisions, advertisements must contain truthful and balanced representations and claims that are valid and have been substantiated Part B1 Requirement 4 Advertisements must not directly nor by implication, omission, ambiguity, exaggerated claim or comparison: a) mislead or deceive, or be likely to mislead or deceive; RESPONSE FROM MEDIA, PHARMACY DIRECT Thank you for your recent letter dated 4th May 2016 advising us of a consumer complaint about a number of arnica products listed on our website from Nature Pharm, Skybright, and Artemis. 5

6 Before I comment on the specific matter of the complaint I wish to clarify how product text is approved for placement on the Pharmacy Direct website: As NZ's leading online Pharmacy we take our responsibility to provide accurate information to the consumer extremely seriously, especially to those shopping independently online, so that they can make an informed and safe choice. The core principle of "First, do no harm" is paramount in the provision of all our services. As such we operate to a very strict set of Standard Operating Procedures and templates for placing products on the site. This template covers information on the potential benefits but also specific information on ingredients, dosage, and risks. ALL material for a product is provided to us directly by the manufacturer or supplier and in the main it is normally TAPS approved prior to being supplied. Note that we do not, under any circumstance, add or embellish in any way the supplied material. We do review and we may remove content we consider not appropriate but overall we do not create any product content ourselves. Manufacturer product information is sourced from product packaging, product fact sheets, and the manufacturers website if they have one. We also operate the business on the mantra "Good health is a right, not a privilege" and we aim to achieve this through giving the consumer choice (Availability) and by making healthcare products as affordable as we can (Affordability). So we hold ourselves accountable to a very high standard at all times, without compromise, and we would never knowingly or intentionally allow content on the site that could mislead consumers, In regards the complaint relating to the arnica products, these have been listed on our site for quite some time using material sourced from the manufacturers as stated above. This content is widely used on websites and by high street stores that will be selling these products. With the current activity around the Natural Health and Supplementary Products Bill (342-2) manufacturers are reviewing all their product collateral and as part of that process they work with us to ensure their products are accurately represented on our site. As a result of this complaint we reviewed the products quoted and have found that some changes in these products had not been notified to us so we will be addressing that issue with these manufacturers directly to remind them of the process they are meant to be following. However we have refreshed the content of all of these products to reflect the current content as can be found on the manufacturers websites and I would hope this addresses the issues raised. I would also note that the complainant's issue appears to be the general availability of arnica as an ingredient in NZ due to their favoured opinion and that is an entirely different matter altogether that cannot inhibit any retailer from legitimately representing and selling the product in a proper manner. So whilst we appreciate this information required updating we would have to refute the complaint that the products in any way make any inappropriate or unsafe efficacy claims or fail to comply with the TPAC core principles 1 to 3. There is a reasonable pool of studies on arnica, some of which are supportive whilst others are unsupportive or inconclusive, and that is where it is vital the consumer can make an informed and safe choice, especially buying online. I hope the ASA can recognise that we take all measures to protect the consumer from any inappropriate content and that we take all consumer concerns as serious and endeavour to respond accordingly and take prompt remedial action when deemed necessary. We believe the revised text should deal to the complaint concerns and would welcome the ASA feedback on the revisions. 6

7 We look forward to hearing from you in due course RESPONSE FROM ADVERTISER, SKYBRIGHT NATURAL HEALTH This letter is in response to complaint Re: Pharmacy Direct Digital Marketing Complaint I would like to take this opportunity to let you know that Skybright is treating this matter with the upmost importance and will assist ASA throughout this process. We acknowledge the fact the complainant has addressed Pharmacy Direct as the primary Advertiser in this instance, however further to our commitment and while you are conducting this investigation, we believe its best practice to respect all parties related in the complaint so I have removed all related Arnica Liniment images, content and related pages from website: Background: I became Managing Director in April this year, to date my primary focus has been on around our brand identity, which includes but not limited to content, process and structure. This being said I would like to point out that we are currently reviewing all print and web content and have engaged the services of a TAPS adjudicator to assist us in this process. I can confirm that Skybright s Arnica Liniment content has been reviewed in the past via the required pre-vetting process please refer to # PP6055 & PP7598 also to assist you with your investigation I have included the full list of ingrediants (listed below) to enable you to make an informed decision. Skybright Arnica Liniment contains: Arnica Witch Hazel Rosemary Lavender Alcohol Summary: We have acted professionally and in the interest of all parties. The removal of this product from our web platform shows our commitment and cooperation to date. 7

8 We pride ourselves on quality, transparency and industry experience and are proud of our position in the Natural Health industry. Thank you for your time so far, please don t hesitant in contacting me if you require any further information. RESPONSE FROM ADVERTISER, ARTEMIS Thank you for the opportunity to respond to the complaint by Mr. Daniel Ryan / The Society for Science Based Healthcare. Mr. Ryan refers to the therapeutic claims being made about our use of Arnica (Arnica montana flos.). He is specifically concerned about the following text: Arnica (Arnica montana flos): is the most effective first aid plant for impact injuries causing bruising, sprains, fractures and muscular and joint stiffness. Arnica is excellent after surgery to relieve trauma and support healing. It supports circulation to the injured area and accelerates healing. The wording in this product listing is taken directly from our website and has been approved for use by TAPS Adjudicator Peter Pratt. The TAPS approval number is PP7926. In response to Mr Ryan s claims, we would firstly like to clarify that we do not use homeopathic preparations of herbs in our products. Mr. Ryan s research evidence makes specific reference to the ineffectiveness of homeopathic products, which ours is not. As an active herbal product, Arnica is a much researched herb. It has a well-established empirical evidence base in the treatment of trauma injuries (e.g. bruises, sprains and fractures) and rheumatic conditions that produce muscular pain and joint stiffness. Arnica is endorsed for the treatment of these conditions by many international regulatory bodies and herbal authorities including the European Medicines Agency, the World Health Organisation, Health Canada, the German Commission E and the European Scientific Cooperation on Phytotherapy. In the construction of their respective monographs and approval for use as an ingredient, these regulatory bodies evaluate a broad array of empirical and clinical evidence to substantiate pharmacological action and efficacy. We have attached these monographs as summaries of the considered evidence in support of Arnica s therapeutic benefits and our product claims. We hope this information helps to address Mr Ryan s concerns. If further information is required, we can provide further copies of individual research papers and trials that speak to the efficacy of this herb. We look forward to hearing the outcome of your decision. Attached: TAPS approval PP7926 American Botanical Council (2000). Arnica Flower. Excerpt from Herbal Medicine: Expanded Commission E Monographs Arnica. Austin, Texas, USA. American Botanical Council / Integrative Medicine Communications. 8

9 ESCOP (2003). Arnicae flos (Arnica Flower). ESCOP Monographs, Second edition. Exeter, UK: European Scientific Cooperative on Phytotherapy / Thieme. European Medicines Agency. (2014). European Union herbal monograph on Arnica montana L., flos. Committee on Herbal Medicinal Products (HMPC). EMA/HMPC/198793/2012. European Medicines Agency. (2014). List of references supporting the assessment of Arnica montana L., flos Final. Committee on Herbal Medicinal Products (HMPC). EMA/HMPC/198792/2012 Health Canada. (2011). Arnica monograph. Natural Health Products Ingredients Database. Retrieved from World Health Organization (2007). Flos Arnicae. WHO Monographs on selected medicinal plants, Volume 3. Geneva, Switzerland: World Health Organization. RESPONSE FROM ADVERTISER, NATUROPHARM LTD A basic, neutral description of the advertisement Date advertisement began Where the advertisement appeared (all locations e.g. TV, Billboard, Newspaper Website Is the advertisement still accessible where and until when? A copy of digital media file(s) of the advertisement if the complaint relates to on-screen graphic, please send a broadcast quality version. Who is the product / brand target audience? Please provide a copy of the media schedule. Pre-vetting Approval number if applicable Four different products for topical application containing herbal Arnica that were included for sale on the Pharmacy Direct website. The product descriptions included information pertaining to typical product use. Some of this information was taken from the Naturo Pharm website, but not all of it. Unfortunately we do not know when the products first appeared on the Pharmacy Direct website. Website: the adverts in question were on the Pharmacy Direct website, with some of the wording having been taken from the Naturo Pharm website As discussed in full in the response document that follows, the product advertisements that appeared on the Pharmacy Direct website that the complaint pertains to have been updated since the complaint was made. The wording that now appears on the Pharmacy Direct website is an exact match for the Naturo Pharm website. See attached folders: Appendix 1 Naturo Pharm web pages Appendix 2 Pharmacy Direct web pages Consumers with an interest in natural healthcare options TAPS Approval No: PP7069 (This is the Approval no. for the Naturo Pharm website) 9

10 Clear substantiation on claims that are challenged by the complainant. Please see the Guidance Note. Please see the response document that follows for a full discussion. Naturo Pharm s Response: Having recently received your letter bringing the issue of complaint to our attention, we were concerned to hear that a complaint had been made against Naturo Pharm products. We take our responsibility regarding responsible advertising seriously and in keeping with this, all advertising material released into the public arena has undergone the TAPS approval process, in an attempt to ensure that we are not in breach of the advertising requirements as they pertain to therapeutic advertising of natural health products. We are taking this matter seriously and trust our response addresses this matter appropriately. While the complaint in question was raised against products as they appeared on the Pharmacy Direct website, this response is not being made on behalf of any other party. As a starting point we would first like to clarify that, while the bulk of the advertisement wording in question was extracted from Naturo Pharm s website (see Appendix 1 Naturo Pharm web pages), there was additional wording included on the website that did not come from Naturo Pharm. Having contacted Pharmacy Direct to discuss the matter of the additional wording, we further discovered that they have recently updated their website and the amended wording is now an exact match to that on our own website (see Appendix 2 Pharmacy Direct web pages). Of the quoted wording in question, the following is from Naturo Pharm s website: Arnica Cream assists the body s natural response to shock, injury, fatigue and bruising and aids normal muscle recovery after strenuous exercise or exertion. Aids normal defence mechanisms in times of trauma and after surgery The following is additional and does contain wording that we understand could represent a therapeutic claim and as such is not in keeping with Naturo Pharm s process of releasing advertising material to consumers: Commonly used to help the body respond to trauma, injuries and shock. Great for bruising, sprains, swelling and other superficial muscle and tissue injuries. We have included bold formatting for the words we believe would be of greatest concern in representing a therapeutic claim, and which are not words that have been extracted from any Naturo Pharm published advertisements. It is, likewise, the additional wording quoted immediately above that has already been removed from Pharmacy Direct s website. Naturo Pharm products, like most complementary healthcare products, are not registered medicines and as such we recognise that we are not able to make therapeutic claims about our products. We make every effort to comply both with the Medicines Act 1981 and the Advertising Codes of Practice. We do not believe that we have made any therapeutic claim in respect of any of our products. All of the material that we make available to consumers is submitted to the Therapeutic Advertising Pre-vetting Service ( TAPS ) for approval prior to its publication and is published with the relevant TAPS reference stated on it. Addressing the complaint: According to the complaint the complainant has complained about the claims Pharmacy 10

11 Direct has made on its website with respect of a number of Arnica products, some of which would be supplied by Naturo Pharm. The complainant suggests that in respect of our products, therapeutic claims have been made that are not true and balanced, thereby contravening the Advertising Code Part B1 Requirement 3. We do not believe that we have represented the products as the complainant alleges. As already mentioned, Naturo Pharm seeks and obtains TAPS approval for material made available to consumers. In this instance the issue is somewhat muddied by the fact that the Pharmacy Direct website did include wording that we understand could represent a therapeutic claim. However, as discussed previously, this wording was not extracted from Naturo Pharm marketing materials and has, further, been removed from their website. The wording that appeared on the Pharmacy Direct website which does seem to have been extracted from Naturo Pham s website, is wording that was TAPS approved, since we have obtained TAPS approval for the whole of the Naturo Pharm website (TAPS Approval No: PP7069). The words used in describing our Arnica products are assists the body s natural response or aids normal. Our understanding is that the use of this type of wording is acceptable and is effectively as far as one can go without making a therapeutic claim. The complainant states that the overall scientific literature doesn t show that Arnica is helpful to the body. While we recognise that there is scientific research that concludes that Arnica is not helpful, there are likewise research studies that show positive outcomes for the use of herbal Arnica. We believe that it is beyond the scope of this complaint to conduct a full literature review on the efficacy of herbal Arnica, considering that while it is required to substantiate direct claims made with scientific evidence, we don t believe that we have made any direct therapeutic claims. If further information in this regard is required in order to settle this complaint then please do not hesitate to contact us. Addressing the relevant parts of the Advertising Codes of Practice: As already stated Naturo Pharm tries to comply with provisions of the Code and we believe that this is the case in respect of both the B1 Requirements 3, 4, 4a; and Principles 2 and 3 to which you have referred us. Monographs published in phytotherapy texts support the use of Arnica in the manner that it has been described in the products under question. We have attached some copies of phytotherapy text references as an example (Appendix 3 Phytotherapy texts), bearing in mind that these are a very small sample and many further examples are available. Considering our use of TAPS approved wording, in which we don t believe that we have made any therapeutic claims, as well as our description of Arnica being in keeping with those suggested by phytotherapy texts; we feel that we have met the principles of having advertisements that present a truthful and balanced representation, and that we have not made any therapeutic claims. For the same reasons we don t believe that we have made any exaggerations in respect of our advertisements, nor have we misled or deceived. By demonstrating a long history (over 30 years) in the industry in which we have made every effort to comply with all regulations, including those of the Advertising Codes of Practice, we feel that Naturo Pharm meets a high standard of social responsibility in respect to advertising our products. 11

12 We have a history of good working relationships with regulatory authorities and wish to maintain these relationships going forward. We believe that the manner in which we have dealt with the complaint demonstrates our commitment to maintaining these relationships and complying with the current regulatory environment. We trust that the information provided is of assistance in your consideration of the complaint that has been made. If we can be of any further assistance please do not hesitate to contact us. We look forward to hearing the outcome of your consideration of these matters. 12