A product listing for the MaxMedix Circulator, a medical device, seen on www.weightworld.uk in October 2017, stated "Home booster device for circulation ... You've probably heard all about the importance of good circulation and the positive effects it can have on the body. Well it's true and there is now a prescription-free option you can use from the comfort of your own home to help you achieve it. The Circulator is a lightweight device that uses innovative Exopulse technology to contract and relax the muscles to help increase blood flow to the legs and feet and relieve pain and swelling. Helps boost circulation to alleviate aches & pain in the feet and legs...After years of research into pulse technology and circulation, MaxMedix have designed the Circulator as a drug-free and non-invasive option to help alleviate circulatory issues such as clots, swelling, cold feet, cramps, calf pain, and numbness".
The complainant challenged whether the efficacy claims in the ad were misleading and could be substantiated.
Comfort Click Ltd t/a WeightWorld said that at the time the ad was seen, it was on “pre-order”, which they considered meant that it was not for sale. They had removed the product from sale while they awaited the completion of medical device certification.
WeightWorld said the claims in the ad simply said the product could “help with” conditions and did not claim any direct physiological change. They submitted previous certification documents for the product as well as testimonials from medical professionals.
The ad stated “… help increase blood flow to the legs and feet and relieve pain and swelling. Helps boost circulation to alleviate aches & pain in the feet and legs … help alleviate circulatory issues such as clots, swelling, cold feet cramps, calf pain and numbness”. The ASA considered that consumers would understand those claims to mean that the MaxMedix circulator could treat the symptoms and conditions listed.
We noted that a button at the top of the page stated “Pre-order now”. We considered that meant consumers could purchase the product for delivery at a later date.
The CAP Code stated that medical claims may be made for CE-marked medical devices. We understood that device certification was granted by notified bodies 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 WeightWorld which stated that the product conformed with the Medical Devices Directive. We noted that they were issued by a company in India, and not a notified body within the EU. We understood from the advertiser that they were in the process of obtaining CE certification for the product. However, we concluded that, because the product did not have the requisite certification at the time the ad was seen, medical claims could not be made about the product.
In any case, CE certification alone did not constitute evidence for efficacy claims. We considered that testimonials were also insufficient to support such claims. Because we had not seen robust clinical evidence for the efficacy claims made in the ad, we concluded that they had not been substantiated and were therefore misleading.
The ad breached CAP Code (Edition 12) rules
Marketing communications must not materially mislead or be likely to do so.
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.
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 ad must not appear again in the form complained about. We told Comfort Click Ltd t/a WeightWorld to ensure they did not make medical claims for products that were not CE-marked medical devices. We also told them to ensure they held robust substantiation for any medical efficacy claims made in their advertising.