Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
A regional press ad for Ultherapy stated "Your Future Face ... Treat your face, neck, brow, jowls, skin etc from inside out in one treatment ... Ultherapy The only technology that treats your face from the foundation up ... WITHOUT A SINGLE INCISION ... FDA Approved Lifting Modality". The ad included two sets of before and after photos.
Issue
The complainant challenged whether:
1. the efficacy claims were misleading and could be substantiated; and
2. the before and after photos were genuine and gave an accurate representation of what could be achieved with the treatment.
Response
1. Lamphall Ltd provided various documents which they said supported the advertised claims. The documents consisted of clinical trials, trial summaries, manufacturer’s brochures and media stories. They said the non-invasive treatment had been widely used by many top surgeons and doctors for the last four years because of its efficacy, it provides more choice and is an alternative to other aesthetic treatments. The advertiser said the treatment resulted in visible skin improvement, firming and tightening with measureable lift of facial contours which developed over time as tissue regenerated. They said the treatment had been carried out with positive results and had very high patient satisfaction ratings. They also provided the product’s US Food and Drug Administration (FDA) approval.
Lamphall said they understood that no one surgical or non-surgical procedure would address every issue associated with ageing and Ultherapy was offered as a treatment package alongside a patient consultation.
The advertiser submitted further information from the manufacturer. They said research on Ultherapy had been published that examined the use of the product on the face, neck and body of over 320 subjects. They said there were also over 30 unpublished pilot and pivotal studies for face and body treatments conducted on hundreds of patients. To support this, they submitted a bibliography and trial summaries.
2. The advertiser said all photographs were genuine and provided to Ultherapy by the doctors and surgeons who used the treatment. They submitted documents which included various before and after pictures from the manufacturer which they said supported the before and after effects of the device.
Assessment
1. Upheld
The ASA considered the ad gave the impression the treatment would improve the overall appearance of several areas of the face. The ad also implied the treatment could be an alternative to aesthetic surgery due to the wording "one treatment", "without a single incision" and "FDA Approved Lifting Modality". We also considered that the before and after photographs emphasised this impression.
We considered the various documents supplied by the advertiser. However, as two studies were conducted on cadaver skin and one on pork skin, we did not consider them sufficient evidence to support efficacy claims for living humans. Of the studies conducted on consumers, we did not consider these sufficiently robust due to the use of a prototype device, small study size, limited facial areas treated and lack of long-term follow up. Additional trials considered the efficacy of the device on several areas of the face and neck. However, some did not examine all areas featured in the ad, for example, under the chin or jowls. Whilst some trials claimed an effect, individual results were not included and therefore it was not possible to analyse the results in full. We acknowledged the bibliography of trials and the manufacturer's assertion that the device had been tested on hundreds of patients. However, we pointed out that summaries of evidence or references would not suffice as evidence as it would not be possible to assess the trials in full.
We acknowledged the document from the FDA, and a further approval was also submitted. However, because the CAP Code stated that the rules applied to marketing communications and not the products, we needed Lamphall to demonstrate that the advertised claims were supported with evidence. We concluded that because the evidence did not support the efficacy claims made for the treatment, the ad was misleading.
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),
3.11
3.11
Marketing communications must not mislead consumers by exaggerating the capability or performance of a product.
(Exaggeration),
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.
and
12.7
12.7
References to the relief of symptoms or the superficial signs of ageing are acceptable if they can be substantiated. Unqualified claims such as "cure" and "rejuvenation" are not generally acceptable, especially for cosmetic products.
(Medicines, medical devices, health related products and beauty products).
2. Upheld
We noted the before pictures featured consumers with notable under eye sagging and the after pictures had significantly reduced sagging. We considered the manufacturer’s before and after pictures but these did not appear to include the consumers featured in the ad. We asked the advertiser for signed and dated proof that the photos were genuine and that they had not been manipulated. This information was not supplied. Because we had not received robust evidence that the pictures were genuine or gave an accurate representation of what could be achieved, we concluded they 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),
3.11
3.11
Marketing communications must not mislead consumers by exaggerating the capability or performance of a product.
(Exaggeration),
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.
and
3.47
3.47
Claims that are likely to be interpreted as factual and appear in a testimonial must not mislead or be likely to mislead the consumer.
(Endorsements and testimonials),
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.
and
12.7
12.7
References to the relief of symptoms or the superficial signs of ageing are acceptable if they can be substantiated. Unqualified claims such as "cure" and "rejuvenation" are not generally acceptable, especially for cosmetic products.
(Medicines, medical devices, health related products and beauty products).
Action
The ad must not appear in its current form. We told Lamphall to hold robust evidence before making efficacy claims and to ensure before and after photos were genuine.
CAP Code (Edition 12)
12.1 12.7 3.1 3.11 3.45 3.47 3.7
