Ad description
Claims on Comfort Click's website for a "Bioenergiser TM Electro Flex Circulation Enhancer" included "Bad circulation is not something you just have to learn to live with. While doctors usually recommend difficult-to-implement solutions to deal with poor circulation, you can fix it by just literally putting your feet up. The Electro Flex Circulation Enhancer works using the traditional art of reflexology to target specific areas on your feet with a tiny electrical current. The Electro Flex Circulation Enhancer has already helped thousands of people to improve their circulation and is medically approved and certified for use in the UK". The ad included further claims about the product and its efficacy.
Issue
1. High Tech Health objected that the product name "Circulation Enhancer" was an implied claim that the product improved circulation and challenged whether it could substantiated.
High Tech also challenged whether the following claims could be substantiated.
2. "Proven to improve circulation and reduce swelling in the legs".
3. "Reduces pain caused by walking".
4. "Electro Flex can bring back normal circulation levels to your body by stimulating the nerve endings with electrical impulses ... With repeated used of the Electro Flex, the muscle becomes 'retrained' to function properly again".
5. "Using Electro Flex to treat poor circulation could not be any easier ... 25 minutes every day is enough to dramatically improve your circulation, reduce water retention and eliminate swelling in your legs".
6. "Electro-Flex has been proven to help treat a number of conditions. As well as blood circulation, it is recommending for treatment in Arthritis, Restless Leg Syndrome, Gout, Muscular Atrophy, Peripheral Neuropathy or Numbness, muscle aches and pain, Lymphoedema and swelling".
7. "Results from first application".
8. The machine is programmed with a selection of treatments, aimed at specific conditions".
The ASA challenged whether:
9. the website references to serious medical conditions could discourage essential treatment.
Response
1. Comfort Click Ltd (Comfort Click) provided trials and reports which they believed substantiated the claim that the product improved circulation, along with the other conditions that were referred to in the ad.
2 - 7. Comfort Click provided a report that examined a range of clinical trials that took place between 1999 and 2010 and which tested the effects of transcutaneous electrical nerve stimulation (TENs) and electrical stimulation devices on symptoms associated with conditions including heart disease, stroke, spinal cord injury, osteoarthritis, rheumatoid arthritis, muscular dystrophy, diabetes and period pain. They also supplied a study into a new development in imaging technology, which stated that different areas of the body emitted different infrared heat patterns and that some medical conditions and injuries could be detected because the affected areas of the body would show up on the image as having different temperature patterns to those detected in healthy individuals. The report stated that the imaging could be used before and after treatment to examine whether the heat pattern in the area under examination had changed following whatever treatment the test subject had received and that it was therefore possible to examine whether the treatment had been successful in that individual.
They also supplied a clinical trial which incorporated the heat imaging technology to examine the heat patterns emitted by the legs of 16 patients before and after a 25 minute treatment with the product and which also examined the effect of the treatment on the subjective symptoms experienced by the test subjects.
8. Comfort Click did not provide evidence to substantiate the claim that the product had a selection of treatments aimed at specific conditions.
9. Comfort Click did not respond on this point.
Assessment
1.– 6. Upheld
The ASA considered that the name of the product “Circulation Enhancer” implied that the product could increase circulation and noted this claim was also made directly in the ad. We noted the report supplied by Comfort Click examined a large number of clinical trials of various sizes which had been carried out on TENs and electrical stimulation devices. However, we noted the trials themselves were not supplied and that Comfort Click had not demonstrated that they had been carried out under controlled conditions or that the products tested were exactly the same as the product detailed in the ad. We therefore considered that Comfort Click had not demonstrated that the outcome of the studies referred to in the report could be extrapolated to demonstrate that the product could be used to treat the symptoms or medical conditions listed in the ad.
We examined the report on the imaging technology and noted it claimed to detect the heat patterns given off by the body. We understood that, because the function of different muscles and organs, the type and amount of heat emitted would vary and they could be distinguished from the areas of the body that surrounded them. However, we noted the study failed to demonstrate that heat patterns in tested individuals could be used to diagnose or examine the conditions or symptoms referred to in the ad and that the trial itself pointed out that it was a pre-diagnosis tool which should not be used alone to diagnose specific conditions.
We also examined the trial on the advertised product which used the heat imaging technology to show heat patterns before and after 25 minutes of treatment with the product. We noted the trials were carried out on 16 individuals between the ages of 50 and 75 years who suffered from symptoms including “intermittent claudation, restless leg, leg ulcers, oedema, lower limb pain and restricted movement”. However, we also noted the trial had not demonstrated that poor circulation had been diagnosed as the cause of these symptoms in those individuals. We noted the trial did not examine arthritis or most of the other conditions specifically referred to in the ad and noted Comfort Click had not demonstrated that the results of the trial on the 16 participants were statistically significant. We noted each of the 16 patients were asked about the symptoms they generally experienced before they received the 25-minute treatment and that they reported symptoms like numbness (in the legs), pain and difficulty walking or standing for long periods of time. We noted the individuals were asked about how they felt following treatment and that they had self reported improvements in subjective elements of their condition such as numbness and stiffness. However, we also noted the trial did not demonstrate that each of these individuals was subject to any objective medical assessment on their condition prior to or following treatment and that the trial was not blinded or placebo controlled. We noted the infrared heat images did show a difference in the amount of heat generated by areas of the legs before and after treatment. However, we considered that Comfort Click had not demonstrated that these changes occurred as a direct result of enhanced circulation.
We considered that Comfort Click had not substantiated the claim that the product increased circulation or that it could be used to treat the symptoms associated with the medical conditions listed in the ad. We therefore concluded that the ad was misleading.
On these points the ad breached CAP Code 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),
3.11
3.11
Marketing communications must not mislead consumers by exaggerating the capability or performance of a product.
(Exaggeration),
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.
and
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.
(Medicines, medicinal devices, health-related products and beauty products).
7. Upheld
The ASA noted the trial on the 16 individuals involved a single 25-minute treatment and that the trial reported that the pain and circulation in the legs of the patients had been observed through the infrared heat images and through patient self-assessments. However, we noted the trials were not blinded or placebo controlled and that Comfort Click had not demonstrated that the results were statistically significant. Furthermore, we noted the trial did not examine all of the patients' symptoms following treatment, such as problems walking or standing for long periods, and that there was no information supplied on how long the reported improvements continued following treatment. We concluded that the trials supplied by Comfort Click did not substantiate the claim that the product showed "results from the first application" and concluded that the ad was misleading.
On this point the ad breached CAP Code 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),
3.11
3.11
Marketing communications must not mislead consumers by exaggerating the capability or performance of a product.
(Exaggeration),
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.
and
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.
(Medicines, medicinal devices, health-related products and beauty products).
8. Upheld
We noted Comfort Click had not provided any information about how their product functioned and considered that they had not substantiated the claim that "the machine is programmed with a selection of treatments, aimed at specific conditions". We therefore concluded that the ad was misleading.
On this point the ad breached CAP Code 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),
3.11
3.11
Marketing communications must not mislead consumers by exaggerating the capability or performance of a product.
(Exaggeration),
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.
and
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.
(Medicines, medicinal devices, health-related products and beauty products).
9. Upheld
We noted the ad stated that the product was proven to help with a number of symptoms that could be associated with serious medical conditions and concluded that some consumers might be discouraged from seeking essential treatment for those conditions.
On this point the ad breached CAP Code rule
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.
(Medicines, medicinal devices, health-related products and beauty products).
Action
The ad should not appear again in its current form. We told Comfort Click to ensure that it held adequate clinical substantiation before making claims that the product could enhance circulation.
