Ad description
The website www.futurapro.info, for health and beauty therapists, stated "The great benefits of ULTRASOUND - In Sonophoresis, electrolypolisis, anti-ageing, breakdown of fatty deposits, stretch marks reduction, improved acneic skin, and tissue massage, to name but a few, can be achieved with the manual Ultrasound Applicato". Photographs showed the applicator being applied to the face and the upper leg.
Issue
A complainant, on behalf of a beauty salon owner, challenged whether the claim "The great benefits of ULTRASOUND - In Sonophoresis, electrolypolisis, anti-ageing, breakdown of fatty deposits, stretch marks reduction, improved acneic skin, and tissue massage, to name but a few, can be achieved with the manual Ultrasound Applicator" was misleading and could be substantiated.
Response
Ultratone Scientific Instruments (Ultratone) said that the Futura Pro System consisted of two ultrasound devices, one of 1 MHz and one of 3MHz. They supplied documentation which they believed substantiated the claim.
Assessment
Upheld
Of the research papers and references Ultratone's response referred to and which they considered substantiated their claim; the ASA noted that full details were supplied of two studies only, which Ultratone had put forward in support of efficacy claims for electrolypolisis and breakdown of fatty deposits. One study had considered the use of ultrasound in producing human autologous collagen. We noted that the document explained the equipment and technique, but that there was no information about the number of participants and whether the study had been controlled or blinded. We also noted that the equipment used in the study was described as between 20 kHz and 3 MHz, which was different from Ultratone's, which they described as consisting of two ultrasound devices, one of 1 MHz and one of 3 MHz. The second study reported on the efficacy of ultrasound assisted liposuction. The document stated that the study had been carried out on 20 healthy volunteers, but contained no information about the power of the device (i.e. whether it was the same as that of the product Ultratone advertised) and whether the study had been controlled or blinded.
The remainder of the documentation Ultratone had supplied consisted of abstracts, articles and references. During the investigation, Ultratone said they were willing to purchase full studies, but we noted that they did not hold them at the time of the ad. Although the documentation they had supplied was positive or cautiously positive about the cosmetic results that could be obtained from the use of ultrasound, it did not contain sufficient detail for us to establish whether the trials were likely to be of a sufficient standard to substantiate the claim. For instance, the abstracts for the most part contained no information about whether the trials had been blinded and/or controlled or whether the device tested was equivalent to the device advertised. Because of that, we considered Ultratone had not substantiated the claim and concluded that it was misleading.
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),
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).
Action
The claim must not appear again in its current form. We told Ultratone Scientific Instruments Ltd to ensure they held adequate substantiation before making efficacy claims in future.
