Ad description
A national press ad for the Lumbros BioFeedbac Support Belt, published on 14 November 2015, was headed "STOP BACK PAIN FAST". The ad featured an image of a spine with the cervical, thoracic and lumbar regions labelled. Text stated "LUMBROS uses patented technology called Biofeedback. This technology is proven to: Prevent back muscle damage Reduce muscle tension Improve and support posture ... Biofeedback utilises the body's own automated awareness and re-educates your muscles to perform at their best ... CLINICALLY PROVEN ... DRUG FREE TREATMENT ... FAST PAIN RELIEF". Next to an image of the device, text stated "Patented technology Combats back pain".
Issue
The complainant challenged whether the claims that the device could treat back pain and that relief would be "fast" were misleading and could be substantiated.
Response
BioEnergiser Ltd stated that the ad only offered to 'treat' back pain, which they understood to be defined as an attempt to deal with something in a certain way, and that they did not claim to 'cure' it. They stated that the product did indeed deal with back pain in a certain way, in that it used the biomechanics principle of proprioception. BioEnergiser provided a list of published clinical trials relating to proprioception and lower back pain. They said the product, when applied to the back region, allowed the spine to reset to its natural neutral position, reducing postural sway and thereby reduce, relieve and alleviate a range of conditions associated with improper alignment of the spine, including soreness in the back, shoulder and neck. They said that when the spine was not in its natural position the back automatically produced symptoms of pain and muscle tension to allow one to be aware that the spine was not correctly aligned and to take action.
Assessment
Upheld
The ad stated "STOP BACK PAIN FAST" and "FAST PAIN RELIEF". We considered that consumers would understand these as claims that using the product would quickly relieve pain in the areas illustrated in the ad (neck, upper and lower back). Also, we considered that, particularly in light of the claim "CLINICALLY PROVEN", consumers would expect these claims to be supported by robust, documentary evidence that the product would have this effect.
We noted the information provided about the trials. We had not been provided with a full copy of each trial or an explanation of how each related to the Lumbros Belt, and were therefore unable to assess fully how robust the conclusions of the trials were or to what degree they substantiated the claims in the ad. From the descriptions provided we understood there was a suggestion that postural sway (the degree to which the lower back curved inwards) was related to lower back pain and that improving sway could improve such pain. However, none of the trials appeared to test the ability of a proprioception belt to relieve pain in the neck, upper back and lower back, or indicate how quickly this would take effect. The trials also did not appear to cover prevention of muscular damage or tension or the improvement of posture in those with lower back pain through use of the belt, which were also referred to in the ad. We noted BioEnergiser's statement that restoring the spine to a neutral position would alleviate pain symptoms. However, in the absence of documentary evidence to show that this effect and any resulting pain relief were produced by the Lumbros Belt, we considered that the claims had not been substantiated and concluded that the ad breached the Code.
The ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
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.
(Substantiation) and
12.1
12.1
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).
Action
The ad must not appear again in the form complained about. We told BioEnergiser Ltd not to make any claims, whether stated or implied, that the Lumbros BioFeedbac Support Belt could relieve pain unless they held robust, documentary evidence to substantiate them.
