Background
Summary of Council decision:
Two issues were investigated, of which one was Not upheld and one was Upheld.
Ad description
A website, www.circulationmaxx.com, made various claims in relation to a medical device.
An additional page stated "Cirulation [sic] Experts - Bioenergiser, over 20 years of bringing you the very best in healthcare. Don't risk your health purchasing Non Class IIa Medical Devices. We can guarantee that our medical devices will deliver the performance and health benefits you would expect from a world class device. Our senior clinician, Dr Paul Clayton, ensures that it delivers the health benefits we state, time-after-time ... We work very closely with leading doctors in their fields, engineers and specialist health institutions to bring you the latest healthcare devices".
A page headed "PRODUCT RANGE (NEW)" stated "Scientifically proven to work" and featured endorsements from Dr Sszacksy and Dr Paul Clayton. It also stated "Circulation Maxx Ultra Winter Pack with Medical Gloves ... to ease sore, painful hands and arms".
The "Corporate Sales" web page stated "Bioenergiser's Circulation Maxx product range is ideal because: Our medical product portfolio has been designed by one of Europe's Premier Doctors in his field - Dr Paul Clayton".
Issue
Actegy Health challenged whether the following were misleading and could be substantiated because:
1. the claims "Circulation Experts", "Our senior clinician, Dr Paul Clayton, ensures that it delivers the health benefits we state, time-after-time", "We work very closely with leading doctors in their field" and "Our medical product portfolio has been designed by one of Europe's Premier Doctor's in his field - Dr. Paul Clayton" did not relate to vascular experts; and
2. the claim "Medical Gloves ... to ease sore, painful hands and arms" was not supported with clinical trials.
Response
1. BioEnergiser Ltd said they had not stated that the experts were vascular surgeons. They submitted the curriculum vitae (CV) of both experts. They said one of the experts was a leading figure in the field of medicine and health and was a former Government advisor. They also said that if Government used his expertise and trusted his judgement, they did too. They said one of the experts was a Fellow of the Royal Society of Medicine and both held a PhD, so were entitled to use the title Dr.
2. They said the health claims did not relate to chronic illnesses and had not stated the claims were supported by clinical trials. They said their customers had commented that the gloves had reduced the soreness of their hands. BioEnergiser also said the ad was in line with the CAP Advice Online entry relating to TENS machines regarding the relief of minor aches and pains. They said the text had since been revised.
Assessment
1. Not upheld
The ASA noted the experts’ qualifications and wide range of professional and academic experience. One expert’s CV showed experience in the field of health, nutrition and other scientific areas. The second expert’s experience was in the field of scientific advice, somatology and anthropology. We noted the ad did not make claims, directly or indirectly, related to the experts’ experience in the field of circulation or as vascular specialists. Furthermore, the ad clearly set out that one expert’s field of experience was in medical pharmacology and in food, nutrition, health and medicines. Because the ad did not make claims of vascular or circulation expertise we concluded the claims were not misleading.
We investigated this point under 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 3.11 3.11 Marketing communications must not mislead consumers by exaggerating the capability or performance of a product. (Exaggeration) but did not find it in breach.
2. Upheld
We noted the advertisers’ assertion that the claim did not refer to a chronic condition and that in the past, CAP had allowed marketers to make claims for the temporary relief of minor aches and pains. However, we understood that TENS machines did not all use the same pulse rates or frequencies and that could affect their efficacy, meaning that some devices might be demonstrably more effective than others. Due to the variation in TENS machines, evidence was needed to support the claims made for this product. We also noted that the ad made claims for the relief of sore and painful arms and the product was worn on the hands only. Because we had not seen evidence to support the claims made, we concluded the ad was misleading.
On this point 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 in its current form. We told BioEnergiser Ltd to hold robust evidence before making claims about their product.
