Ad description
A press ad, claims on the website www.advancedestheticssolutions.co.uk, and an e-mail promoted "Lipofirm Plus".
a. The press ad, which appeared in a trade magazine, stated "Lipofirm Plus Evlaser's Credible Alternative to Liposuction creating INCH LOSS, BODY CONTOURING and SKIN TIGHTENING - all in ONE SYSTEM! ... Lipofirm Plus is one of the very few systems that is MEDICALLY CERTIFIED with clinical studies".
b. A claim on the website stated "LIPOFIRM PLUS Europe's No 1 inch loss, body contouring and skin tightening system".
c. An e-mail, sent from Advanced Esthetics Solutions Ltd, stated "With in excess of 4000 installations throughout Europe, Lipofirm Plus is the market leader in utilising a multiple platform using Ultrasound and Radio frequency for facial and body contouring, it is also one of few devices on the market that has medical certification".
Issue
Bio-Therapeutic UK Ltd challenged whether the following claims were misleading and could be substantiated:
1. "Europe's No 1 inch loss, body contouring and skin tightening system";
2. "With in excess of 4000 installations throughout Europe ...";
3. that Lipofirm Plus was medically certified; and
4. that Lipofirm Plus had been subject to clinical trials.
Response
Advanced Esthetics Solutions Ltd (AES) stated that they were the sole distributors for Evlaser, a company based in Italy that manufactured the Lipofirm Plus, which was a combination of two other devices called "Slim Cav Pro" and "Twin Trend".
1. AES said Evlaser had manufactured the technology utilised in the device for over six years and had installed over 4000 units throughout Europe. They stated that no other company had manufactured and installed that number of devices. They also said it was the only ultrasound cavitation system on the market that had an adaptive mode within the hand piece, which meant the frequency which could be applied changed depending on the characteristics of the skin during the treatment. In addition, they highlighted that their cavitation hand piece had a minimum guaranteed life of 12 months, which none of their competitors offered. They also stated that, for the radio frequency the product offered, it came with a higher number of hand pieces than other comparable products.
2. AES provided a letter from Evlaser which confirmed that the Slimcav Pro and Twin Trend had been part of their portfolio for over five years and that "The sale of these two devices has been successful for Evlaser during the said period with in excess of 4000 units sold".
3. AES said the Lipofirm Plus was the brand name of the product in the UK, and that the two devices it incorporated, "Twin Trend" and "Slimcav Pro" had medical certification. They provided a copy of that certification which listed a number of different products including the "Twin Trend Med" and the "Slim Cav Med Plus". In comparison with the "Twin Trend" and "Slimcav Pro", AES explained that the "Med" products had a higher output for the medical profession, but that those higher specifications were within the Lipofirm Plus. They also provided an additional response from Evlaser which stated that legislation varied in different countries in respect to the permitted usage and qualification of the operative. They explained that the majority of Evlaser devices were manufactured for the medical and aesthetic industries and to satisfy all countries' in respect to the permitted usage, Evlaser had applied for, and received, medical certification from CERMET - the Italian authority for the certification of quality of goods, services and systems. Because of the versatility of both technologies Evlaser said they had decided to combine both machines in one platform, but that the technology, protocols and certifications remained the same.
4. AES stated that to achieve medical certification, independent clinical trials had to be carried out on both devices, and they provided copies of those two studies.
Assessment
1. Upheld
The ASA considered that the claim "Europe's No 1 inch loss, body contouring and skin tightening system" was likely to be interpreted by readers to mean that the Lipofirm Plus was the best-selling device of its kind in Europe, and that it had achieved more installations than its competitors. We noted that Evlaser claimed they had installed in excess of 4000 units across Europe, but understood that those installations were of the "Twin Trend" or "Slimcav Pro", and not solely the Lipofirm Plus. In addition, we noted that neither Evlaser nor AES had provided any comparative evidence to show that the number of installations of the Lipofirm Plus was greater than similar devices on the market. We therefore concluded that the claim was misleading and in breach of the Code.
On that point, the claims 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 3.38 3.38 Marketing communications that include a comparison with an unidentifiable competitor must not mislead, or be likely to mislead, the consumer. The elements of the comparison must not be selected to give the marketer an unrepresentative advantage. (Other comparisons).
2. Upheld
We understood from the documents provided that Evlaser had installed over 4000 units of the "Twin Trend" and "Slimcav Pro" devices over the past five years. We considered, however, that readers would understand the claim "With in excess of 4000 installations throughout Europe, Lipofirm is the market leader ..." to refer solely to the Lipofirm Plus, and not the two separate devices it incorporated. Therefore, in the absence of any evidence to prove that more than 4000 units of the Lipofirm Plus had been installed across Europe, we concluded that the claim was misleading and in breach of the Code.
On that point, the claims breached CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising) and 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).
3. Upheld
The ASA noted from the certificate provided that the "Twin Trend Med" and the "Slim Cav Med Plus" had been certified as compliant with the Medical Devices Directive by an authorised Notified Body. Although we understood the same technology within both devices was utilised by the Lipofirm Plus, we noted that that device did not appear on the certification provided. We considered that readers would understand the claims "Lipofirm Plus is one of the few systems that is medically certified ..." and "it is also one of few devices on the market that has medical certification" to mean that the Lipofirm Plus had medical certification, rather than that it utilised technology which had been certified. We therefore concluded that the claim was misleading and in breach of the Code.
On that point, the claims 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
12.1
12.1
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).
4. Upheld
We noted that in order to be granted medical certification, both the "Twin Trend Med" and "Slim Cav Med Plus" had been subject to medical trials. Although we understood that the technology within both the "Twin Trend Med" and the "Slim Cav Med Plus" was utilised by the Lipofirm Plus, we considered that readers would understand the claim "one of the very few systems ... with clinical studies" to mean that the Lipofirm Plus, not the two devices it incorporated, had been subject to clinical studies. Because we had not seen any evidence to show that the Lipofirm Plus had been subject to medical trials, we concluded that the claim was misleading.
On that point, the claim breached CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising) and 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).
Action
The claims must not appear again in their current form. We told AES to ensure they held robust evidence to substantiate the claims made in their advertising in future.
