Summary of Council decision:
Three issues were investigated, all of which were Upheld.
Ads for Lyclear shampoo lice treatment:
a. The voice-over in a TV ad stated, "My friend's recommended an unbeatable treatment for head lice." Small print stated "Two applications needed. Ex vivo study 2010, data on file". The voice-over continued, "Double action Lyclear shampoo. Suffocates. Dehydrates. And is guaranteed to remove 100% of head lice." A woman was shown using the product on a child's hair, massaging it in and then washing it out in the bath. On-screen text stated "100% EFFECTIVE". The voice-over stated, "And it's as easy as washing hair. Lyclear shampoo. 100% effective." On-screen text stated "100% EFFECTIVE".
b. The Lyclear website www.lyclear.co.uk, included a web page for Lyclear shampoo which stated "100% effective" and "100% effective.* Repeat the treatment after 7 days". Small print at the bottom of the page stated "*Kills 100% of head lice and near to 100% of eggs. Use sufficient product and comb thoroughly to be certain all eggs are removed from the hair. Ex vivo study 2010, data on file".
The ASA received three complaints.
1. Three complainants, including Thornton & Ross Ltd, challenged whether the claims "Suffocates. Dehydrates. And is guaranteed to remove 100% of head lice" in ad (a) and "100% effective" in ads (a) and (b) and were misleading and could be substantiated.
Thornton & Ross Ltd also challenged whether:
2. the claim "And it's as easy as washing hair" in ad (a) was misleading, because they believed this implied the process was easier and quicker than it was; and
3. the claim "unbeatable" in ad (a) could be substantiated.
1. Omega Pharma Ltd said that Lyclear shampoo was a class 1 medical device and consisted of a surfactant, emulsifier and foaming agent. They said the product had a double action that both dehydrated head lice and their eggs and suffocated the lice. They provided a clinical study of the shampoo in which 29 subjects with head lice were treated twice with a 7- to 9-day interval. They said that the cure rate was 90% and that these results demonstrated that Lyclear shampoo was an effective head lice treatment. They said that following this clinical study the product formulation was optimised and an optimal comb was also identified. They said the revised comb was a fundamental aspect in support of the claim. They said the optimised formula was tested in an ex vivo study, which they provided, showed that it was 100% effective at killing head lice. They said the study results showed 100% mortality against head lice and 96.5% mortality against eggs. They said that studies had also been carried out on Lyclear spray, but that it was not appropriate to extrapolate fully the results from the clinical study, although they considered the results informative. They said that Lyclear shampoo contained mineral oils and tensioactives and that mineral oils were proven to both suffocate and dehydrate head lice, and therefore achieve the same result, in two treatments, as was seen in Lyclear spray, which contained the additional ingredient dimethicone. They said the shampoo was formulated to obtain maximum effect on head lice and eggs. They said that the oil's high affinity for the epicuticle of the head lice made them and the eggs more vulnerable to dehydration. They said that the oil also acted as a suffocant. They said the tensioactives meant the formula foamed on the hair after the addition of water, and because it did not contain any silicones (such as dimethicone) it did not leave any greasy residue on the hair. They said that dimethicone and mineral oils were proven suffocants and dehydrants both in combination and alone, and that this was supported by the clinical data for each product.
Clearcast said the ad made clear that two applications of the product were required for it to be 100% effective. They said the advertiser provided them with evidence for the same claim in relation to Lyclear spray and that before approving it they sent it to a consultant. They said the consultant was satisfied that the evidence supported claims that the spray suffocated and dehydrated lice, and that it was 100% effective when used twice. They provided a copy of the consultant's view and the evidence supplied to them by the advertiser, which consisted of an ex vivo study and a clinical study. They said that although the original substantiation had been provided for Lyclear spray, they understood the mode of action for both the shampoo and the spray was the same, and they were therefore satisfied the evidence was sufficient.
2. Omega Pharma said that the product would foam on the hair when combined with water, just like a standard shampoo. They said that in contrast with other head lice treatments it was not necessary to apply shampoo separately, as the product would also wash the hair. They said the product did not contain any silicones and so would not leave any greasy residue on the hair.
Clearcast said that the product worked in the same way as shampoo and that you applied the product, waited ten minutes and then you used water to lather the product and washed it off as you would shampoo. They said the product contained mineral oil which would be easily washed out, and no silicones, and that there was no need to use a separate shampoo. They said that although the pack instructions contained a number of other steps, these were designed to make clear how to use the product and also contained steps that did not relate to use of the product, such as combing dry hair for lice and eggs first, and then combing out the lice and eggs after use. They also said they believed that the average consumer would be aware that dead lice needed to be combed out to be removed. They said the ad was designed to show the use of the product itself, and that many generic shampoos required the product to be left on for a period of time. They therefore did not believe the ad implied the process was easier and quicker than it was.
3. Omega Pharma said that test data showed that Lyclear shampoo was 100% effective and that it was therefore unbeatable. Omega Pharma said they were not aware of any products outside of their range that were proven to treat head lice in one treatment. However, they believed that the claim would still be supportable even if that was the case, because the claim was a top parity claim and was supported by the evidence.
Clearcast agreed with Omega Pharma's response, and said that the existence of a product which worked in one application would not have affected their view of the claim, which they regarded as a top parity claim rather than a superiority claim.
The ASA had been provided with an ex vivo study and a clinical study by Clearcast. However, these related to Lyclear spray rather than the Lyclear shampoo referred to in the ads. We understood that the spray contained an active ingredient, dimethicone, which was not present in the shampoo, and noted that Omega Pharma said that it was not appropriate to extrapolate fully the results from the Lyclear spray clinical study to the shampoo. We therefore considered that, although the studies were background information, they did not constitute substantiation for the claims in relation to the shampoo.
Omega Pharma had provided two studies which related to the shampoo, an ex vivo study and a clinical study. However, the clinical study concluded that the shampoo was only 90% effective after two treatments. The ex vivo study had then been conducted on an optimised formula, and showed 100% mortality against head lice and 96.5% mortality against eggs. Both ads included small print which stated "Ex vivo study 2010, data on file". However, we considered that robust evidence was still required to support the claims and that, for a claim of 100% effectiveness of a head lice treatment, robust evidence included a relevant clinical study. Because we had not been provided with robust evidence that the product was "guaranteed to remove 100% of head lice" and "100% effective", we therefore concluded that the claims had not been substantiated.
On this point ad (b) breached CAP Code (Edition 12) rules 3.1 3.1 Advertisements must not materially mislead or be likely to do so. (Misleading advertising) and 3.7 (Substantiation) and ad (a) breached BCAP Code rules 3.1 3.1 Advertisements must not materially mislead or be likely to do so. (Misleading advertising) and 3.9 3.9 Broadcasters must hold documentary evidence to prove claims that the audience is 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 (Other comparisons).
The ASA considered that most viewers would be aware that head lice treatments usually required the use of a comb. However, we also noted that the product was described as a shampoo and the claim stated that using it was "as easy as washing hair", which we considered implied the product was particularly easy to use and very similar in process to normal hair washing. We noted that instructions for using the product included leaving it on the hair for ten minutes and that the use of the product shown in the ad did not include any qualification that this was required. It was also necessary to comb out head lice after washing the product out and we noted this was not referenced or shown in the ad. We considered that the claim implied the process of using the product was easier and quicker than it was and therefore concluded that it was misleading.
On this point ad (a) breached BCAP Code rules 3.1 3.1 Advertisements must not materially mislead or be likely to do so. (Misleading advertising) and 3.9 3.9 Broadcasters must hold documentary evidence to prove claims that the audience is 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).
We considered that the claim "unbeatable" was a top parity, rather than superiority claim. However, because we had not been provided with robust evidence that the product was 100% effective, and Omega Pharma had said that other products in their range were 100% effective, we concluded the claim the treatment was "unbeatable" had not been substantiated.
On this point ad (a) breached BCAP Code rules 3.1 3.1 Advertisements must not materially mislead or be likely to do so. (Misleading advertising) and 3.9 3.9 Broadcasters must hold documentary evidence to prove claims that the audience is 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 (Other comparisons).
Ad (a) must not be broadcast again in its current form, and ad (b) must not appear again in its current form. We told Omega Pharma Ltd to ensure they did not imply the treatment process was easier and quicker than it was. We also told them not to claim or imply that Lyclear shampoo was "100% effective" or "unbeatable" unless they held robust evidence to support those claims.