Summary of Council decision:
Two issues were investigated, both of which were Upheld.
An advertisement feature in the national press for a product called FLX Knee, seen on 7 October 2017, included various claims regarding the product's efficacy in relation to knee pain. The feature also included a testimonial from "Edward G, Leeds".
The complainant challenged whether:
1. the claims that the product was effective in the treatment of knee pain were misleading and could be substantiated; and
2. the testimonial from Edward G from Leeds was genuine.
1. UK Direct Shop Ltd’s marketing agency 2020DM, responded on their behalf. 2020DM stated that patella straps were commonly used to help relieve mild patella tendonitis (‘jumper’s knee’) and Osgood-Schlatter’s disease, and could help with treatment and management of knee pain. The FLX Knee strap was specifically designed to help provide relief for such symptoms. They said the ad clearly communicated that the strap could provide ‘relief’, ‘ease discomfort’ and ‘helping to relax’. They further stated that the ad did not make any claims that went beyond the effectiveness of the product, and that there were no implied claims that the product could permanently fix a serious knee problem, or was a cure for knee pain.
202DM stated that they contacted the fulfilment house for any negative feedback about the product and understood that they had not received any complaints.
2. 2020DM stated that the testimonial was taken from a customer letter, which their client confirmed that they held on file, along with signed authorisation from the customer to use the testimonial for marketing purposes.
The ASA noted that the ad included the following claims: "FLX Knee brings you relief from the pain of strained or injured knees - and also protects your knees from further injuries ...", “FLX Knee is designed to bring relief and ease the discomfort of aching knees. It takes the pressure off your knee, providing protection from everyday stresses and strains that can wear down your knees and compromise an active lifestyle”, “It can also help with a number of specific knee problems including: Patellar Tendonitis, Patellar Tracking, Runner’s Knee, Jumper’s Knee, Knee Injuries and Sprains. It offers support and relief …”, “… the band applies gentle pressure on the joint liner and patellar tendon, helping to relax muscles and relieve pain, stiffness and inflammation”, and “New device for anyone with knee pain - instant relief”. We considered that those claims were medical claims that the product would alleviate knee pain in general (including pain from the conditions referred to), treat inflammation and prevent future knee injuries.
The CAP Code required that medicinal or medical claims and indications were made only for a medicinal product that was licensed by the MHRA or under the auspices of the European Medicines Agency (EMA) or for a CE-marked medical device. Whilst we noted UK Direct Shop’s comments, we had not seen any documentary evidence to demonstrate that the FLX Knee strap was CE-marked, and therefore considered that the product was not a CE-marked medical device. Because of that, no medical claims could be made for the product. In addition, we had not been provided with any documentary evidence to substantiate the efficacy claims above made for the knee strap.
Because the ad made medical claims for a product which was not a CE-marked medical device, and because we had seen no evidence to substantiate those claims, we concluded that the ad was misleading.
On that point, 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).
We considered that consumers were likely to expect that the testimonial featured in the ad were the genuine views of a customer who had used the FLX Knee product. Notwithstanding UK Direct Shop’s comments that they held a copy of the customer’s letter from which the testimonial was taken and the customer’s permission for the testimonial to be featured in the ad, we had not been provided with any evidence to demonstrate that the testimonial was genuine. We therefore concluded that the use of the testimonial in the ad was misleading.
On that 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 3.45 3.45 Marketers must hold documentary evidence that a testimonial or endorsement used in a marketing communication is genuine, unless it is obviously fictitious, and hold contact details for the person who, or organisation that, gives it. (Endorsements and testimonials).
The ad must not appear again in its current form. We told UK Direct Shop Ltd to ensure that they did not make medical claims for a product, unless it was a CE-marked medical device and they held evidence that it was effective in alleviating knee pain in general (including pain from the conditions referenced), treating inflammation and preventing future knee injuries. We also told UK Direct Shop Ltd to ensure that they held documentary evidence to demonstrate that testimonials used in their ads were genuine, and held the contact details for the people who gave them.