Background
Ad description
Text on the Direct Healthcare Ltd website, for the Electroflex Circulation Booster Massager, stated that the product could "improve blood circulation, reduce swelling, ease aches and pains ... fluid retention and numbness in the lower limbs" and "increase oxygenation and nutrition retention".
Issue
High Tech Health Ltd, who did not believe the efficacy claims for the product could be substantiated, challenged whether they were misleading.
Response
Direct Healthcare Ltd (Direct Healthcare) agreed to remove the references to fluid retention, numbness in the lower limbs and nutrition retention. They submitted details of a pilot study that measured the effects of a Bioenergiser Electroflex electrical stimulation device on lower limb circulation in 16 subjects. They said the document stated 15 of the 16 cases showed a significant improvement in circulation after a single treatment. They said, because improved circulation relieved tired and aching legs, the summary that related to specific cases where circulation was improved, substantiated the claim that the product could improve blood circulation and relieve tired and aching legs. They also said the results showed a slight reduction of lower limb oedema in several subjects and reduced limb heaviness, coldness and pain in all subjects, and believed this substantiated the claims that the product could reduce swelling and pain.
They submitted a core claims document that looked at the evidence for the therapeutic benefit derived from electrical nerve/muscle stimulation. They said this document reported that patients suffering from chronic obstructive pulmonary disease were unable to gain sufficient oxygen from the lungs, but that stimulating the muscles in a way that did not increase breathing rate could, over repeated treatments, improve heart and lung function. They believed this substantiated the claim that the product could increase oxygenation.
Assessment
Upheld
We welcomed Direct Healthcare's assurance that they would remove the references to fluid retention, numbness in the lower limbs and nutrition retention. We noted the study stated imaging scans detected the diameter, degree of function, degree of pain and/or discomfort in the lower limb parameters of subjects suffering from claudication, “restless leg”, leg ulcers, oedema, lower limb pain and/or restriction of movement and that, after a single treatment with the product, imaging scans showed that 15 out of 16 participants had improved circulation, several showed slightly reduced lower limb oedema, while all reported that they had reduced lower limb heaviness, coldness and pain. However, we noted the trials themselves were not supplied and that Direct Healthcare had not demonstrated that they had been carried out under controlled conditions, or that the product tested was the same as the Electroflex Circulation Booster Massager detailed in the ad. We therefore considered that Direct Healthcare had not demonstrated that the results referred to in the report could be relied on to demonstrate that the product in the ad could be used to improve circulation, or reduce lower limb oedema.
We noted that the core claims document stated that patients suffering from chronic obstructive pulmonary disease were unable to gain sufficient oxygen from the lungs but that stimulating the muscles in a way that did not increase breathing rate could, over repeated treatments, improve heart and lung function. However, we noted the full trials had not been submitted, and that the advertiser had not shown that the product worked in the same way, or stimulated muscles to the same degree as the device used in the study. We considered that, in the absence of trials using the advertised product, or evidence showing that the results claimed for other devices used on people with chronic conditions were likely to be replicated by use of the Electroflex Circulation Booster Massager among the target audience for the ad, the efficacy claims made had not been substantiated. We 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),
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.
12.2
12.2
Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered (see rule
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.
).
Health professionals will be deemed suitably qualified only if they can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of members' skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.
and
12.6
12.6
Marketers should not falsely claim that a product is able to cure illness, dysfunction or malformations.
(Medicines, medical devices, health-related products and beauty products).
Action
The ad must not appear again in its current form. We told Direct Healthcare Ltd not to repeat the claims for the Electroflex Circulation Booster Massager unless they held robust evidence to substantiate them.
