A YouTube ad and a website, for the HoMedics’ Leg Exerciser, seen on 10 November 2015:
a. The YouTube ad featured a presenter who stated, “As we get older, it’s important that we keep fit and active. But that may not always be easy or even possible … a new device helps you enjoy the benefit of gentle leg and feet exercises without having to leave your chair … Regular use could help reduce stiffness and tiredness in your legs and feet and many users have found that it could improve their overall lifestyles.” The ad featured several people who talked about the HoMedics’ Leg Exerciser. One person stated, “Since using the leg exerciser, I have a lot more energy to keep up with my grandchildren” and another stated “The best thing about it is I don’t really have to go out of my way to exercise”. The ad also included scenes of consumers using the device, which showed it moving their legs backwards and forwards without any input from the users.
b. The website www.homedics.co.uk stated, “The HoMedics Leg Exerciser provides an easy way to keep joints mobile. Helps to improve circulation in legs and feet. Can help to reduce swelling and aching in your legs and feet. Helps to improve … Tiredness in the legs and feet … Discomfort in feet and legs … Sore and aching legs … Leg cramping … Inflammation in knee and ankle joints … General mobility … Overall energy levels. When regular exercise becomes a challenge because of age, illness, reduced mobility or disability, the HoMedics Leg Exerciser provides an easy way to keep joints mobile by providing regular gentle exercise from the comfort of your own chair”.
The complainant challenged whether the claims “Regular use could help reduce stiffness and tiredness in your legs and feet … I have a lot more energy … an easy way to keep joints mobile … Helps to improve circulation in the legs and feet … Can help to reduce swelling and aching in your legs and feet … Helps to improve … Tiredness in the legs and feet … Discomfort in feet and legs … Sore and aching legs … Leg cramping … Inflammation in knee and ankle joints … General mobility … Overall energy levels” in ads (a) and (b) were misleading and could be substantiated.
HoMedics Group Ltd said to substantiate the claims and prove the benefits of the product they had commissioned a home use consumer survey for the Leg Exerciser and provided that study.
They said the Leg Exerciser was a fully certified CE device, designed to offer potential lifestyle improvements for consumers. They said the product provided a gentle lower leg and ankle exercise for individuals who felt they did not get enough movement in their legs. They said users of the device might benefit from the gentle movement which helped to keep joints active and mobile, as well as providing a psychological benefit through the feeling of doing something rather than being sedentary.
The ASA considered that consumers would understand from the claim “a new device helps you enjoy the benefit of gentle leg and feet exercises without having to leave your chair” in ad (a), the scenes of the product in action and the claim “the HoMedics Leg Exerciser provides an easy way to keep joints mobile by providing regular gentle exercise from the comfort of your own chair” in ad (b), to mean that the product enabled users to passively move their lower legs with little or no active involvement from the user. Furthermore, we considered that the overall impression of both ads, particularly in light of the references to a number of ailments such as poor circulation, mobility and discomfort, was that users would gain benefits akin to partaking in active exercise and also resolve what could be long standing conditions such as general and joint immobility, poor circulation, sore and aching legs and joint inflammation.
We noted that the CAP Code required that objective claims, including medical claims for a CE-marked medical device, be backed by evidence, if relevant, consisting of trials conducted on people. We understood that the device certification was granted by a body within the European Member States that had been designated to carry out conformity assessments under the Medical Device Directive. We reviewed the documents provided by HoMedics in relation to their assertion that their Leg Exerciser was certified as a medical device and noted that they were issued by a company based in China and not a designated body within the EU. We therefore considered that the product was not registered as a medical device and because of that, no medical claims could be made for the product.
We considered that the ad made various direct and indirect medical claims for the HoMedics’ Leg Exerciser. For example, that the product could improve overall mobility for consumers with movement problems, provide pain relief for consumers with inflammation or tired, sore and aching legs, and affect a physiological response to improve circulation, leg cramping and to reduce swelling in the legs and feet. We acknowledged HoMedics’ consumer survey. However, we did not assess that document because of the product’s lack of a medical device certification.
Because the ads made medical claims for a product which was not a CE-marked medical device we concluded they breached the Code.
The ads breached CAP Code (Edition 12) rules
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising) and
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).
The ads must not appear again in their current form. We told HoMedics Group Ltd not to make unsubstantiated medical claims for a product that was not CE-marked.