Background
Summary of Council decision:
Three issues were investigated, all were Upheld.
Ad description
The Bodi-Tek website www.bodi-tek.co.uk featured a product called "Bodi-Tek Circulation Plus". Text stated "Boosts lower leg and foot circulation ... Swollen feet, aching and heavy feeling legs can be the result of poor circulation. The Bodi-Tek Circulation Plus uses EMS technology to repeatedly contract and relax the muscles in the lower legs and feet simulating normal exercise while seated. The repeated contraction and relaxation of the muscles in the lower legs and feet in turn induces something known as the 'muscle pump action,' which boosts blood flow and blood circulation. While the Circulation Plus should not be seen as a substitute for normal active exercise it does provide a means of exercising the lower legs passively while seated or otherwise relaxing ...".
Issue
Actegy Ltd t/a Actegy Health and Bioenergiser Ltd challenged whether the following claims were misleading and could be substantiated:
1. "Boosts ... foot circulation";
2. "Bodi-Tek Circulation Plus uses EMS technology to repeatedly contract and relax the muscles in the lower legs and feet"; and
3. "boosts blood flow and blood circulation."
Response
1. & 3. The Dezac Group said the relationship between contraction of the calf and lower leg muscles and consequent venous pump action, which increased circulation, was a well-documented and well-understood scientific principle. They supplied an extract from a university textbook which they believed supported their view. They said the Circulation Plus "passively" contracted and exercised the lower leg muscles and recruited the "muscle pump" to increase or boost circulation. They said that applied to all users with normal function in their lower limbs. They said pooling of blood in the legs and resultant swelling could affect otherwise healthy individuals. In that situation, pooling was not a "medical condition" but, nevertheless, where someone was sedentary for long periods of time or in situations where lower limb exercises might be recommended, an otherwise healthy individual could consider electrical muscle stimulation (EMS) passive exercise. They cited a study which they believed supported the view that leg activity was an important factor in prevention of swelling. Another study, which had found that muscle inactivity could induce the development of lower limb blood flow stasis (stagnation) and venous thrombosis (blood clots) in healthy individuals, found that subjects with chronic venous insufficiency (long-term problems with blood flow) showed a threefold increase in swelling rate, compared with healthy, able-bodied subjects. The Dezac Group cited a number of studies which had looked at how electrical stimulation of the lower limbs resulted in muscle contraction and could improve blood flow.
The Dezac Group did not believe the ad made any direct or implied medical or health claim. They said the Medicines and Healthcare products Regulatory Agency (MHRA) had reviewed the product and the claims and had confirmed that it was not a medical device. The Dezac Group said that symptoms of swelling in the feet and feelings of heaviness in the legs were often described anecdotally by those who experienced them as being the result of poor circulation, without the intention of making a medical claim. They said the claims regarding the relief from these symptoms that could be obtained by using the device reflected the language used by those who experienced the symptoms. They said the claim that swollen feet and aching and heavy legs "... can be the result of poor circulation" was a cautiously-worded claim. They said there might be medical conditions that exhibited similar symptoms but that the ad did not target consumers with medical conditions. They believed the passive exercise offered by the device made it no different in that respect to any other piece of exercise equipment which encouraged the use or engagement of lower leg muscles while seated. They said the ad stated "While the Circulation Plus should not be seen as a substitute for normal active exercise it does provide a means of exercising the lower legs passively while seated or otherwise relaxing ...".
2. The Dezac Group supplied a web link to a video which they believed demonstrated by observation how the electrical muscle stimulation (EMS) provided by the Circulation Plus and a similar device resulted in similar and substantial calf muscle contractions and provided a means of exercising the lower legs passively while seated or otherwise relaxing. They said the results applied to all users with normal function in their lower limbs and that no medical, lasting or long-term benefits were claimed.
Assessment
The ASA had taken advice in other investigations that related to ads for EMS circulation devices and we took additional informal advice in this case. We considered that it was well established that nerves and muscles could be stimulated electrically if a device delivered an electrical current of sufficient amplitude. If the device delivered electrical current of sufficient amplitude to cause significant mechanical contraction of either calf muscles, foot muscles or both, we considered that a plausible mechanism existed by which electrical stimulation could affect circulation. We considered there would always be some increase because of the simple mechanical forces on the blood vessels, but whether any such effect was actually relevant to the body would depend on the size of the contractions, their locations, their duration and the age or condition of the blood vessels and surrounding tissue.
1. & 3. Upheld
We noted that the MHRA did not consider the product met the criteria for being a medical device for their purposes. We considered that the claims suggested that use of Circulation Plus boosted blood flow and blood circulation in the feet in people who experienced the symptoms of swollen feet and aching and heavy legs that resulted from poor circulation that were described in the ad. We considered the product name, Circulation Plus, also suggested that the device boosted blood circulation. We accepted that the demonstration video showed that, in the situation it portrayed, stimulation through the feet had resulted in muscle contraction in the lower legs and feet. To support the claims that had been challenged, we considered the Dezac Group needed to hold evidence that demonstrated that people who had experienced the symptoms of poor circulation described in the ad had experienced a boost in foot circulation, blood flow and blood circulation from using Circulation Plus or an equivalent device.
Of the studies the Dezac Group had supplied, four referred to stimulation being applied to the calf muscles, to the peroneal nerve (located between the knee and the ankle) or the lower leg muscles by the placing of electrodes. Although that mode of use was different from the one used by Circulation Plus, we considered that, since the demonstration video had shown that Circulation Plus was capable of causing a similar contraction of the calf muscle by applying stimulation through the soles of the feet, the results of studies which also used devices on subjects who were seated and which showed a similar contraction of the calf muscle would be relevant. However, of those four studies, one stated that participants were between 23 and 34 years of age with an average age of 26.5 and two stated that they had used healthy volunteers or healthy subjects. This is commented on further below.
We noted that a fifth study referred to electrical stimulation being applied to the feet, but through pads that were placed in socks and operated by battery while the user continued to walk around as normal. An abstract of a sixth study contained no information on where stimulation had been applied and appeared to have assessed swelling, but its conclusions regarding efficacy were unclear.
We noted that a seventh study had involved stimulation being applied to the soles of the feet using a device that was similar to Circulation Plus. We noted that the participants averaged 33 years in age with a maximum of 41 years; were otherwise healthy; had taken part on the basis of blood pooling/swelling induced by 40 minutes of motionless sitting and had had stimulation applied at 50% of their pain threshold for 10 minutes. We noted that the report did not state the stimulus current or pulse frequency and did not take into account the possibility that users might, for reasons of comfort, choose a level of stimulation that was too low to be effective and that the report had not been published and had not been subject to peer review.
One of the four studies that referred to stimulation being applied to the calf muscles, to the peroneal nerve or the lower leg muscles by the placing of electrodes, one had used 10 patients with class six (the most severe) chronic venous disease. Electrodes were applied to the back of each patient's calf; sufficient electrical stimulation was applied to result in contraction of the calf muscle and blood flow was measured. The authors believed that the results showed that electrical stimulation may prove useful in the treatment of patients with venous ulceration who had reduced mobility or reduced ankle movement. However, they acknowledged that the results had not been consistent and had concluded that further research was needed. Furthermore, we noted that the trial had been conducted in a different way from how Circulation Plus was used, in that subjects had been standing and, at one point during the testing, had changed from the standing position to a "tip-toe" position, which caused an exaggerated calf muscle contraction that was not caused by the device.
We accepted the general principle that, if a device delivered electrical current of sufficient amplitude to cause significant mechanical contraction of either calf muscles or foot muscles, or both, a plausible mechanism existed by which electrical stimulation could affect circulation and that there would always be some increase because of the simple mechanical forces on the blood vessels. However, while we considered that a device of sufficient power may temporarily improve lower leg blood circulation in healthy individuals who were seated or inactive for long periods of time, we considered that the claims "boosts ... foot circulation" and "boosts blood flow and blood circulation" suggested to people with the condition poor circulation (rather than healthy individuals who were seated or inactive for long periods of time) that the device would be effective for them. We considered that the results of trials that had been conducted on young and/or healthy volunteers could not be extrapolated to people with the condition poor circulation. The results of trials that delivered stimulation while the subject was mobile (as was the case with the device where electrical stimulation was applied to the feet through pads that were placed in socks and operated by battery while the user continued to walk around as normal) also could not be extrapolated to a device that was designed to be used by subjects who were seated and immobile (Circulation Plus), and that the results of the trial that had been conducted on subjects with chronic venous disease were not conclusive and also could not be extrapolated to a device that was designed to be used by subjects who were seated and immobile (Circulation Plus).
For the reasons discussed above, we did not consider the evidence submitted by the Dezac Group was sufficient to substantiate the claims and concluded that they were misleading.
On points 1. & 3., 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).
2. Upheld
Notwithstanding that the claim related primarily to the technical or mechanical way in which the device worked, because the claim referred to the action "... to repeatedly contract and relax the muscles in the lower legs and feet", we considered that it was unlikely to be seen in isolation and, in the context of the claims "boosts ... foot circulation" and "boosts blood flow and blood circulation", it suggested an efficacy claim. As we have discussed in relation to points 1. & 3. above, while we accepted the general principle by which the device was claimed to function, we did not consider the evidence submitted by the Dezac Group was sufficient to substantiate the efficacy claims we considered the ad made. Because of that, we concluded that the claim was misleading.
On point 2., 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 claims must not appear again in their current form.
