A national press ad for Slimspired's 3D Lipo, a fat reduction treatment, seen on 28 March 2017 was headed “The no-gym solution to a bulging belly!”. Text stated “… IF YOU are searching for a way to get the figure you want without the hard work, you need 3D-Lipo! … 3D-Lipo targets your body’s fat cells using a combination of tried and tested technologies including cavitation and dermology”. Further text stated “Shifts stubborn fat fast! No pain, no exercise, no recovery time … plus instant results guaranteed!”.
The complainant challenged whether the ad misleadingly implied that the product could reduce fat and aid weight loss.
Medspa Pro Ld t/a Slimspired said that there were many studies which showed that 3D Lipo was safe and effective in reducing fat layer circumference on the abdomen. They said that as part of their treatment, they advised patients to take part in a calorie restriction diet. Further information about the diet was available on their website.
Slimspired provided three clinical studies. The first study investigated the effectiveness of combining medical technology, diet and lifestyle changes to achieve weight loss. The second study looked at the effect of ultrasound cavitation therapy on adipose tissue thickness in Egyptian women. The final study assessed the efficacy of a non-invasive focused ultrasound system on body contouring.
The ASA considered that the claims “The no-gym solution to a bulging belly!”, “… get the figure you want without the hard work” and “shifts stubborn fat fast!” would be interpreted by consumers to mean that the 3D Lipo treatment could reduce fat and aid overall weight loss without the need to exercise.
We considered that such claims should be supported by robust evidence, including clinical trials of the treatments on people demonstrating the efficacy of the treatment.
We assessed the clinical studies provided by Slimspired. We had concerns that the first study assessed a combination of a 3D Lipo device, a lifestyle programme with diet advice, exercise and motivational support and therefore did not accurately represent the product offered by Slimspired. We noted that the ad stated “no-gym solution” and “no exercise” and therefore considered that the study contradicted the claims in the ad. We were also concerned at the small sample size and that the study was not randomised, double blinded or controlled. Furthermore, we noted that the study was authored by the medical directors of a company that offered 3D Lipo which we considered introduced the possibility of bias. We therefore considered that the study was not sufficiently robust to support the claims in the ad.
The second study was conducted on 60 obese Egyptian women aged between 30 and 50 years with a body mass index from 22 to 35 kg/² with "butt obesity" (waist hip ratio less than 0.8) and at least 2.5 cm of fat thickness in the treatment area (able to pinch at least one inch). The study made clear that anybody who did not meet those specific requirements could not participate. We considered that the specificity of the inclusion criteria was such that the study could not produce results to support the wide ranging general efficacy claims. We acknowledged that the study was randomised, triple blinded and placebo controlled and therefore of a higher quality than the other studies provided. However, we noted that no information was provided about how the randomisation was carried out. In the absence of that information, we were unable properly to assess the methodology of the trial. While we noted that the results showed a statistically significant decrease in fat thickness matched with a significant increase in waist-hip ratio among women in the intervention group after treatment, there were no significant differences regarding weight loss at the end of the programme between the two groups. We also considered that because both groups received diet advice, we were unable to assess the individual impact of the 3D Lipo on the fat loss achieved. We further noted that measurements were made after a six-week period. We considered that the claims such as “shifts stubborn fat fast!” and "instant results guaranteed” would be understood to mean that effects would be seen quickly and did not consider that consumers would interpret claims suggesting that the effects of a treatment were achievable after a six-week period.
The final study was authored by staff members, including the medical director, of a Spanish clinic that offered 3D Lipo treatments. We considered that those factors introduced the possibility of bias. We were also concerned that the study was not randomised, double blinded or controlled. We did not consider the study was sufficiently robust to support the claims in the ad.
Because of the limitations identified with the evidence supplied, we considered that we had not seen sufficient evidence to support the efficacy claims. We therefore 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) and 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. (Weight control and slimming).
The ad must not appear again its current form. We told Slimspired to ensure that they held robust documentary evidence for all their claims in future.