Background
Summary of Council decision:
Four issues were investigated, all of which were Upheld.
Ad description
A listing on Amazon.co.uk for TENS Electrode Gloves was headed "TENS Electrode Gloves - For sufferers of Arthritis, Sports Injuries, RSI, Carpel Tunnel Syndrome & Raynauds Syndrome". Text next to the product picture stated "Relief to the whole hand, Can aid mobility, Can help with Swelling, One size fits all, Can be used with any TENS/Circulation Massager device". Text further down the page stated "Using the TENS glove can give relief to the whole hand and aid mobility. This is an accessory for a TENS/Circulation Massager machine. Can be used with Electroflex, Circulation Maxx and Circulation Maxx Ultra. If you suffer from Repetitive Strain Injury, Carpal Tunnel Syndrome, Raynauds Syndrome or other chronic pain conditions in you [sic] hand, this could be the answer to your prayers. This glove harnesses TENS technology, allowing the stimulation from the unit to reach the whole hand. The stimulation improves the blood flow, which in turn can increase mobility in the fingers and provides relief throughout the whole hand. Everybody suffers from pain at some stage of their lives, but not everybody wants to tackle it by taking endless drugs and experiencing invasive surgical procedures. An effective, powerful alternative is the medically-approved electro-therapy known as TENS.
TENS stands for Transcutaneous Electrical Nerve Stimulation. It consists of a small unit, attached to the body via electrode pads, through which a harmless electrical signal is passed. The sensation is not painful or unpleasant, and can be likened to "pins and needles", or even gentle massage. This signal triggers the nerve endings, activating the pain gate and boosting the release of endorphins. The pain gate effectively stops pain signals from reaching the brain, whilst endorphins are the body's own natural defensive mechanism to ease pain. TENS is used by physiotherapists, doctors and midwives, as well as individual patients with varying degrees of pain".
Issue
Actegy Health Ltd challenged whether the following claims could be substantiated:
1. "Relief to the whole hand";
2. "Can aid mobility";
3. "Can help with swelling"; and
4. that the product could benefit people with "Arthritis, Sports Injuries, RSI, Carpel Tunnel Syndrome & Raynauds Syndrome".
Response
1., 2., 3. & 4. Tower Health Ltd said that they would make changes to the ad which they believed were sufficient. They said the product was a glove that plugged into a TENS machine to provide TENS therapy to the whole hand. They said they understood from CAP guidance that they were therefore able to refer to providing 'temporary relief'.
Assessment
1., 2., 3. & 4. Upheld
The ASA noted that Tower Health had removed and amended some of the claims. However, we considered that the ad still contained efficacy claims for the product. 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. We considered that because of the variation between machines and because this device involved the application of TENS by the gloves only, rather than by electrodes, we needed to see evidence to demonstrate the efficacy of the specific product. Because we had not seen evidence to support the claims we concluded that they had not been substantiated.
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 its current form. We told Tower Health Ltd not to state or imply that the product could relieve pain, aid mobility, help with swelling or benefit people with arthritis, sports injuries, RSI, carpel tunnel syndrome & Raynaud's syndrome unless they held robust evidence that demonstrated efficacy of the gloves.
