ASA Adjudication on Allergan Ltd

Ad

A TV ad for a dermal filler had a voice-over that stated "Discover Juvederm ULTRA injections" as on-screen text stated "Facial wrinkles? Discover Juvederm ULTRA injections". The ad featured a woman looking at her reflection in a pool of water and touching the surface of the water. The voice-over continued "For facial wrinkles. Smooth ... immediately effective ... wrinkle treatment ... long lasting". The ad showed an image of a feather landing on a pool of water, and absorbing the circles on the surface of the water. On-screen text stated "Juvederm ULTRA must be administered by a qualified medical aesthetic practitioner". The voice-over stated "Experience the difference. Natural beauty without surgery". The ad finished with an image of the product and on-screen text that stated "Juvederm ULTRA, natural beauty without surgery. To find a clinician or learn more go to www.juvedermultra.com".

Issue

1. Some of the viewers, who had seen the ad during programmes that were likely to be watched by children and young teenagers, challenged whether, given the nature of the product, the ad was suitable to be seen by children and should have had a scheduling restriction.

2. One viewer challenged whether the term "qualified medical aesthetic practitioner" implied that only doctors registered with the General Medical Council (GMC) could administer the injections, whereas he believed that was not the case.

3. The ASA challenged whether the efficacy claims made about the product could be substantiated.

BCAP TV Code

Response

1. Allergan Ltd (Allergan) said the product was a medical device, and that in line with Clearcast's guidance the ad had not been broadcast on dedicated children's channels, or during children's programmes and strands on other channels, or in the ad breaks immediately before or after those programmes. They said the ad did not show the product being administered to children and did not use imagery or cartoons likely to appeal to children. They said that view was shared by Clearcast, who had not placed a scheduling restriction on it.

Allergan said they believed it was unlikely that the commercial had been widely viewed by under 16-year-olds, because they had targeted the ad at women over 35 years of age. They said the media buying agency had carefully selected specific channels, programmes and times of the day in order to maximise exposure to their target audience, and minimise the number of children exposed to the commercial. Allergan submitted data that they said showed that they had successfully targeted their core audience of women over 35 whilst limiting the number of children exposed to the commercial.

Clearcast said they had not traditionally given products of that nature a timing restriction. They said Allergan had provided a copy of the transmission schedule for the ad, which showed the ad had been broadcast during adult programming in the main, and during daytime programming that was not of particular interest to children. Clearcast said the ad was restrained and lacked any sort of youth appeal.

2. Allergan said they did not believe the term "qualified medical aesthetic practitioner" implied that only doctors registered with the GMC could administer the product. They said the term was chosen to accurately reflect the wide range of practitioners engaged in the delivery of injectable cosmetic treatments, and was not interchangeable with the term 'doctor'.

Allergan explained that, due to the nature of the product (a dermal filler containing 0.3% of the local anaesthetic lidocaine), only practitioners holding a valid professional qualification such as a medical or dental qualification, or a qualified nurse, should administer the injection. They said the term 'qualified medical aesthetic practitioner' recognised the special nature of the product and directed consumers to an appropriately trained professional. They explained that that term was in line with the Independent Healthcare Advisory Services (IHAS) Standards for Injectable Cosmetic Treatments. They said IHAS Standard 9 stated that patients should receive treatment from an appropriately trained and competent clinician, and recommended that that clinician should: be registered with an appropriate professional body and have professional indemnity insurance; have the appropriate clinical qualifications to make a safe assessment as to the suitability of treatment based on the medical history of the patient; have received appropriate training, including regular updating of their skills. Allergan argued that, while that Standard made it clear that the clinician should be properly qualified and registered with their professional body, it clearly referred to a broad body of practitioners and was not restricted to doctors registered with the GMC only.

Clearcast said they and their medical consultant considered the word 'aesthetic' removed any implication that the product could only be administered by a doctor registered with the GMC.

3. Allergan explained that Juvederm Ultra was a long-lasting, resorbable Hyaluronic Acid (HA) dermal filler that contained 0.3% Lidocaine for improved ease of injection, reduced pain and improved subject comfort. They said it  was suitable for injection into the medium and deep dermis to treat moderate to severe wrinkles and folds. They said that dermal fillers were growing in popularity because they produced immediate benefits and required very minimal downtime. They explained that patients were able to see the immediate effects of the product as the filler flowed into the dermis and filled out the wrinkle or fold.

Allergan submitted copies of clinical trials in support of the efficacy claims. They sent a study that assessed post-injection smoothness of Juvederm Ultra 3, which they said showed that post-treatment smoothness was considered to be 'excellent' in 67% of cases and 'good' in 26% of cases when assessed by the injector. Allergan also provided a pan-European study that they explained focused on a number of endpoints, including injector and patient assessment of the effectiveness of the treatment measured as satisfaction with the aesthetic result. They said over 95% of injectors involved in the study rated the aesthetic effect of the product as 'excellent' or 'good'. Allergan said the "long-lasting" claim was supported by a clinical trial that showed that there was still a clinical difference after Juvederm Ultra injection at one year. They said Juvederm Ultra products were the only HA dermal fillers on the market that were approved by the US Food and Drug Administration for lasting up to one year.

Clearcast said their medical consultant had assessed Allergan's substantiation and was satisfied that it supported the efficacy claims made in the ad.

Assessment

1. Not upheld

The ASA noted the responses of Allergan and Clearcast. We noted that care had been taken to broadcast the ad away from children's programmes or dedicated children's strands, and that Allergan had targeted their audience of adult women over 35 years old as far as possible, by weighting the transmission of the ad after 8 pm. We considered that the ad was unlikely to be of particular appeal to children in either its design or imagery and we also noted that the ad did not show the product being administered. We understood that some viewers might find the product distasteful. However, we considered that the ad itself was unlikely to cause distress or harm to children, and we therefore concluded that it had been scheduled appropriately.

On this point we investigated the ad under CAP (Broadcast) TV Advertising Standards Code rules 7.4.1 (Mental harm) and 7.4.7 (Use of scheduling restrictions) but did not find it in breach.

2. Not upheld

We noted the arguments put forward by Allergan. We also noted that the product could only be administered by practitioners who held a professional qualification, such as a doctor, dentist or nurse, because it contained a local anaesthetic. We considered that the term "qualified medical aesthetic practitioner" indicated to consumers that the product should be administered by a suitably qualified practitioner, but we also considered that the term was unlikely to be understood by most people as referring to doctors who were registered with the GMC only. We therefore concluded that on this point the ad was not misleading.

On this point we investigated the ad under CAP (Broadcast) TV Advertising Standards Code rule 5.1 (Misleading advertising) but did not find it in breach.

3. Not upheld

The ASA took advice from an expert.

We noted that the studies provided by Allergan assessed the efficacy of Juvederm Ultra for use on nasolabial folds. We understood from the expert that some dermal fillers were hard, firm gels that could form lumps under the skin if not administered correctly. While we acknowledged that the smoothness of the product would therefore depend to some extent on the skill of the practitioner, we accepted that the product had been rated as producing a smooth appearance by the majority of practitioners in one of the studies and had been compared favourably for smoothness with other similar products in a single-blind trial by the trial subjects. We also understood from the expert that the nature of the product was to introduce volume into the skin, and that the product would provide an immediate filling and 'plumping up' of the skin, which would reduce the appearance of lines and wrinkles. We noted the expert's explanation that in most cases post-injection massage of the product by the practitioner was required in order to distribute the product evenly and physically smooth it. However, we considered that, because a filling effect would be seen directly upon injection of the product,  it was reasonable to state that the product was 'immediately effective'.

We understood that one of the studies submitted by Allergan was a double-blinded, multi-centre trial on 280 subjects, designed to assess the long-term effectiveness of the product. We also understood that the study showed an improvement in the appearance of nasolabial folds that persisted after treatment for a period between nine months and one year. We considered that consumers who were interested in using dermal fillers were likely to be aware that the product would not produce a permanent effect and that further 'top-up' injections would be needed. We also considered that, in that context, it was reasonable to claim that a temporary effect that lasted for a period of 9 to 12 months was "long-lasting". We therefore concluded that the efficacy claims had been substantiated.

On this point we investigated the ad under CAP (Broadcast) TV Advertising Standards Code rules 5.2.1 (Evidence) and 5.2.2 (Implications) but did not find it in breach.

Action

No further action necessary.

Adjudication of the ASA Council (Broadcast)