Claims on the website www.trionz.co.uk promoted a range of magnetic wristbands.
A page entitled "Clinical Trials" referred to research conducted on the products. Claims included "The results have shown that in the real bracelet condition there is a significant difference (a positive improvement) for all 3 tests of pain, stiffness and ease of functioning. The mean differences of before wearing the bracelet to after wearing it are as follows: 24.5% PAIN DECREASED - 21% STIFFNESS DECREASED - 15.3% FUNCTIONING WAS EASIER" and "These results show without doubt the efficacy of Colantotte products to assist with relief from a number of conditions and the increase of mobility, which can be a significant benefit to people of all ages, including those interested in improving sporting performance".
A page entitled "Magnetic Therapy" stated "Magnetic therapy is the use of magnets to help create a beneficial environment that promotes the bodies [sic] own healing processes. When magnets are applied to the skin, they produce physiological effects in the body and blood flow. Clinicians who have studied the effects of magnetic therapy have estimated that its effectiveness s [sic] relieving pain is 85 percent [sic] ... Relief is usually rapid, with muscle pain for example often diminishing within 30 minutes." The page also contained an explanation of "HOW RED BLOOD CELLS RESPOND TO MAGNETISM"; this indicated that the magnetic field increased blood flow and also induced red blood cells to separate from each other, increasing their surface area to foster better transport of oxygen and nutrients around the body. Further text included "Colantotte improves circulation and relieves stiffness", "ALLEVIATES PAINFUL STIFFNESS IN THE SHOULDERS, HIP AND NECK" and "... simply wearing the gear relieves stiffness in that part of the body". A number of pictures resembling infra-red imaging appeared to indicate more heat to various parts of the body on which Colantotte magnets were described as being worn. One image was accompanied by the claim "Improves circulation and relieves stiffness".
Text on a page entitled "Dr. Sarah Brewer" contained quotes attributed to "Dr Sarah Brewer, MSc (Nutr Med), MA (Cantab), MB Chir, RNutr, MBANT, CNHC, FRSM", the "Author of Healing with Magnetic Therapy". Text stated "I am a firm believer in magnetic therapy and regularly recommend magnetic healing to people who embrace complementary medicine and are committed to a healthy lifestyle ... I am especially impressed by the Trion:Z/Colantotte brand ... [I] have now switched to the Trion:Z bracelet. Not only do they help to boost fitness performance, they also help users to maintain their wellbeing". A second quote, which was also repeated on the "Clinical Trials" page, referred to the trial and stated "Greater improvements were seen in those wearing the bracelets, which confirms my clinical observations that magnetic therapy bands help to improve quality of life by reducing pain and stiffness".
A page entitled "Testimonials" contained a number of testimonials from customers, detailing their experiences of using the wristbands.
The bottom of every page of the website contained a box with an image of Dr. Sarah Brewer and the text "'I came across magnetic therapy about 10 years ago when I had a jogging related injury. A friend suggested I try it and I was impressed with its rapid effects.' Dr Brewer says magnetic therapy is 85% more effective at relieving pain than many drugs: 'It can be used to treat many different conditions'".
The complainant challenged whether the efficacy claims for the products, including those contained in the testimonials, were misleading and could be substantiated.
Sales Marketing Solutions Ltd t/a Trion:Z and Colantotte, provided a copy of the study referenced on the website, which they considered supported the claims in their marketing. They also confirmed that the bracelets they sold were registered as Class I medical devices.
The ASA understood that the products sold by Sales Marketing Solutons were registered as Class I medical devices. Product classification related to the potential safety risk associated with the device and Class I devices were sold on a self-declaration basis without having been assessed by any notified body.
The CAP Code required that objective claims, including medical claims for a CE-marked medical device, be backed by evidence, if relevant, consisting of trials conducted on people. We therefore considered the study supplied by Sales Marketing Solutions in support of their claims. The study had not been published and, therefore, had not been subject to peer review. We noted that it had been conducted using participants experiencing ongoing pain in joints below the waist, but considered that the claims on the website relating to both the study specifically and more generally the efficacy of the bracelets, implied that the products could be beneficial for the population at large. Although one of the "key findings" reported on the "Clinical Trials" page of the site stated "Bracelets, powered by Colantotte magnets reduce pain in joints of the lower body ...", that did not explicitly state that only those with lower joint pain had been included in the trial. In addition, it was accompanied by further text within the same "key findings" section of the page stating that the bracelets were "effective for everybody regardless of age, sex or health", and was not in any case sufficiently prominent within the web page to contextualise the more general claims as to the efficacy of the bracelets.
Nevertheless, participants in the study had been randomly allocated to one of three test groups: the first wore active Colantotte bracelets; the second uncharged Colantotte bracelets (the placebo group); and the third wore no bracelet at all. Participants in the first two groups were asked to wear the bracelet assigned to them for at least all of their waking hours over a period of four weeks and all three groups completed self-assessment questionnaires relating to pain, stiffness and ease of daily functioning at the beginning and end of the trial. We were concerned that the methodology by which the trial had been conducted was not always clear, and that no reference was made to blinding procedures, without which there would be a significant risk of bias in the results. Furthermore, a number of participants had been excluded from the results analysis because they did not meet unspecified inclusion criteria, and whilst the study provided various statistical analyses of the results obtained it did not include the raw data itself. Moreover, the study reported no significant difference between results obtained from the two bracelet-wearing conditions (those wearing the charged bracelets and those wearing the uncharged placebo bracelets). Notwithstanding our concerns regarding the methodology of the study, we considered that this finding suggested that the positive difference in reported pain, stiffness and ease of functioning scores between the start and end of the study could not reliably be attributed to the wearing of the charged Colantotte bracelets.
We further noted that many of the claims on the page entitled "Magnetic Therapy" related to matters that had not been examined during the study. Examples included the claim "Relief is usually rapid, with muscle pain for example often diminishing within 30 minutes", the explanation of how red blood cells "respond[ed] to magnetism"; the claim "ALLEVIATES STIFFNESS IN THE SHOULDERS ... AND NECK", and the images indicating greater heat delivery to the hand, arm and back in association with references to relief of stiffness and improved circulation.
The "Testimonials" page of the website also contained a number of both direct and implied claims as to the efficacy of the product in alleviating pain, improving physical performance and treating a variety of medical conditions. In addition, Dr. Sarah Brewer was reported as being "impressed with its [magnetic therapy's] rapid effects" and stating that magnetic therapy was "85% more effective at relieving pain than many drugs: 'It can be used to treat many different conditions'". A further endorsement from the same person included the text "I have used magnetic jewellery every day for years, and have now switched to the Trion:Z bracelet. Not only do they help to boost fitness performance, they also help users to maintain their wellbeing". We considered that all of those claims, as well as the claim, on the "Magnetic Therapy page, that "Clinicians who have studied the effects of magnetic therapy have estimated that its effectiveness s [sic] relieving pain is 85 percent [sic]", would be understood by consumers as factual claims relating to the efficacy of the products sold by Sales Marketing Solutions and were therefore likely to mislead unless they were supported by robust documentary evidence.
For the reasons outlined above, we considered that the study submitted was insufficiently robust in both methodology and findings to support the efficacy claims made by Sales Marketing Solutions. In the absence of adequate substantiation, we concluded that all of the efficacy claims, both those directly linked to the study and those contained in testimonials or referring to the mechanism by which the products were alleged to work, were misleading and in breach of the Code.
The claims breached CAP Code (Edition 12) rules
Marketing communications must not materially mislead or be likely to do so.
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
Claims that are likely to be interpreted as factual and appear in a testimonial must not mislead or be likely to mislead the consumer.
(Endorsements and testimonials) and
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease. (Medicines, medical devices, health-related products and beauty products).
The claims must not appear again in their current form. We told Sales Marketing Solutions Ltd not to make efficacy claims for their products unless they held adequate documentary evidence which directly related to each of the claims they made.