A website for weight loss and cosmetic treatment clinic Alevere Ltd, www.alevere.com, seen in April 2017, included text on the FAQ page under the question “Why do I need the treatments as well as the diet?” that stated, “Because losing weight does not automatically mean you will be left with the great body shape you want - so we shape it for you. We make sure you lose inches in the places you want, as well as losing weight overall, and we tighten and firm your skin. We achieve this in two ways: Firstly, we use state-of-the-art ultrasound technology to break down those stubborn fat deposits under your skin - there is scientific evidence to prove it works. This is a really important treatment because dieting alone often won't shift these thick stores of fat. If they were to stay, you would still be unhappy with your figure even after losing all the weight. Then, we make your skin contract as you lose weight by tightening and firming it all over, using technology that stimulates it to make collagen and elastic fibres. This treatment also smooths out bumpy and uneven skin and improves your lymphatic drainage, so that the fat broken down by the ultrasound is more easily removed by your body”.
The complainant challenged whether the treatment claims were misleading and could be substantiated.
Alevere Ltd said provided a number of scientific clinical papers, which they stated were approved and published in well-known plastic surgery journals, as well as other documentation in support of their efficacy claims.
The ASA considered that the claims would be interpreted by consumers to mean that the treatments offered by the advertiser would cause weight loss, specifically fat reduction, and firm and tighten the skin subsequent to weight loss, using an ultrasound and other unnamed technology that had been scientifically proven to be effective. We noted that the advertiser also offered a diet and weight management programme but we considered that these claims would be understood as meaning the specific treatments had an effect that went beyond any weight loss achieved through dieting and exercise alone.
We considered that such claims should be supported by robust evidence, including clinical trials of the treatments on people that have demonstrated the efficacy of the treatment.
We considered the evidence supplied by the advertiser. We also noted one of the devices they used as part of the treatment, the LPG Cellu M6 Alliance Medical, had a CE mark certificate. The certificate was supplied to the ASA, but we did not consider that this alone was capable of substantiating the weight loss and skin firming and tightening claims made in the ad.
We were provided with abstracts that we did not regard as providing sufficient detail to support efficacy claims and one document, a PowerPoint presentation, that did not provide the requisite level of detail to determine whether the conclusions were based on robust methodological design. Similar to the PowerPoint presentation, a paper that summarised other studies that did not provide sufficient details regarding its subjects and methodology has been considered inadequate substantiation.
We noted that the conclusions of three studies supplied undermined rather than supported the efficacy claims. For example, by stating the treatment should not be regarded as an effective body contouring method and that there was no definitive non-invasive treatment method for cellulite and subcutaneous fat. Two further studies that reported positive results and included sham treatment control groups did not appear to have measures in place to control diet and lifestyle changes in the participants. Further, one of the studies only had three participants, which we did not consider to be a sufficient sample size to generalise findings to the wider public. We considered that the lack of provision for such variables made the results unreliable. Three more studies were not controlled or blinded, and we considered that these factors undermined the robustness of the methodology used. Another study tested porcine skin and observed that the study observations would not be able to predict clinical results; we also considered this was not adequate substantiation. We also had concerns about the financial independence of some of the studies’ authors.
The final study supplied, which was controlled, randomised and double-blinded, used a device that did not appear to have the same mechanism as the device used by the advertiser. The results of the study also related to skin sagging and the authors noted this was an observed finding that was not statistically significant. Because the results were not statistically significant and the device was not the same as the one used by the advertiser, we did not regard the final study as adequate substantiation.
Because of the issues identified with the evidence supplied and the lack of scientific evidence that demonstrated that ultrasound or the other unnamed technology could sustain weight loss or firm and tighten skin, we considered the claims relating to weight loss and skin firming and tightening had not been substantiated and were misleading.
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), 13.1 13.1 A weight-reduction regime in which the intake of energy is lower than its output is the most common self-treatment for achieving weight reduction. Any claim made for the effectiveness or action of a weight-reduction method or product must be backed, if applicable, by rigorous trials on people; testimonials that are not supported by trials do not constitute substantiation. and 13.4 13.4 Before they make claims for a weight-reduction aid or regimen, marketers must show that weight-reduction is achieved by loss of body fat. Combining a diet with an unproven weight-reduction method does not justify making weight-reduction claims for that method. (Weight Control and Slimming).
The ad must not appear again in its current form. We told Alevere not to claim that their treatments could lead to weight loss or firm and tighten skin or that they were scientifically proven to do so, unless they held adequate substantiation of efficacy.