Ad description
An ad shown both on TV and on Youtube promoted a teeth whitening product:
a. The TV ad featured a close-up of a woman smiling and a graphic of eight different shades of tooth colour. The woman's teeth whitened as a marker slid from the darker to the paler end of the scale. The voice-over stated, "iWhite teeth whitening kit. Instant results in up to eight shades whiter, and clinically proven safe and effective." Large text at the top of the screen stated "INSTANT results*" and "Up to 8 shades whiter". Small text at the bottom of the screen stated "*Instant results, up to 8 shades whiter after 1 application of 20 minutes".
b. The same ad was shown on a Youtube channel belonging to the advertiser's Business Unit Manager.
Issue
Colgate-Palmolive UK Ltd, who considered that the ad exaggerated the product's efficacy, challenged whether the whitening claims in the ads were misleading and could be substantiated.
Response
Fdd International Ltd provided a copy of a clinical in-use study that they considered supported the claims in the ad. They said the study had been conducted by an independent healthcare professional with appropriate experience in the field and had followed guidelines on good clinical practice. They considered that it was robust in terms of participants, methodology and data analysis. They said all assessments of tooth colour had been carried out in a well-defined dentist cabinet facing north during daylight, with the participants stood a uniform distance from the investigator, which ensured constant and validated clinical investigation parameters. They noted that 68% of participants were recorded as having achieved a shade improvement after one application of iWhite Instant for 20 minutes (the recommended application time). They described that as a significant result proving the efficacy of the product and substantiating the claims in the ad regarding "instant" results.
Fdd also supplied a copy of raw data relating to the study, which included information on the age and gender of participants and their tooth colour both before the start of the trial (their "baseline") and after one application of the product. They noted that the study included both smokers and non-smokers and said the baseline shades covered the majority of the shade guide and represented a standard distribution, meaning that the sample of participants was representative of the population. They also submitted a statistical analysis, using a two-sided significance level of 5%, of the results achieved by the study. They commented that that showed that mean shade improvement was not affected by gender or smoking behaviour, and that there was no relationship between age of the participant and the level of shade improvement recorded. They noted that the statistical analysis demonstrated a higher degree of shade improvement for participants with a high baseline score (i.e. darker teeth), which was logical because those participants would have more room for improvement in their tooth colour.
Fdd said the claims that use of the product could result in teeth "up to eight shades whiter" were supported by the fact that two out of the 25 participants in the study were recorded as having achieved a result of eight shades whiter after one application. They also considered that the spread of results as a whole supported the claim. In respect of the sliding marker used in the ad, they believed that that indicated the nature of the "up to eight shades whiter" claim by depicting the range of improvement that could be achieved through use of the product.
Clearcast said they, in consultation with their expert consultant, had considered that the evidence supplied to them by the advertising agency supported the whitening claims in the ad. They said they had specifically required the inclusion of the qualification "after 1 application of 20 minutes" to the "instant" claim to ensure that it did not exaggerate the efficacy of the product. They supplied a copy of the evidence they had assessed, which included the same trial as that provided by Fdd.
Assessment
Upheld
The ASA considered the in-use study supplied by Fdd and Clearcast, which measured the tooth shade of 25 participants before and after use of iWhite Instant. Although the primary objective of the study was described as being to determine the whitening effect of the product after two applications, measurements had also been taken after only one application and we understood that it was upon those results that the whitening claims in the ad were based. Seventeen of the participants were recorded as having experienced some degree of shade improvement (measured against a guide containing 16 incremental shades) after one 20-minute application, with two results being eight shades whiter than the initial baseline. We sought expert advice on the in-use study and accompanying documentation supplied by Fdd.
We noted that the study had not been published and therefore had not been subject to peer review. We understood that it would normally be necessary for an investigator taking qualitative measures, such as visually assessing tooth colour against a shade guide, to demonstrate their ability to take, reliably, those recordings. We considered it a weakness of the study that it did not contain details of any calibration exercise undertaken by the investigator to demonstrate a consistent approach to assessing tooth colour. We were further concerned that the study was not blinded; no control group existed (and therefore there was no randomisation of treatments); and both investigator and participants appeared to be aware of the objectives of the study. We understood that the lack of blinding procedures was not indicative of good clinical practice.
In relation to the sample of 25 participants, the study noted that no formal sample size calculation had been performed, but that that number was considered to be logically feasible and adequate to assess the proof of principle study. Although we considered it would be preferable to conduct a formal calculation demonstrating the rationale for a particular sample size, we understood that on this occasion it was likely that 25 participants would have been sufficient to deliver statistically significant results. We noted that that was reflected in the statistical analysis supplied by Fdd.
However, we were concerned by the lack of commentary in the study as to what level of shade improvement would be classed as a clinically significant result. We understood that that would typically form part of a sample size calculation and would also be applied to an analysis of the results obtained. We considered that consumers were likely to understand the whitening claims in the ad, including "clinically proven ... effective", to be based on data that demonstrated a clinically (and statistically) significant positive effect on tooth colour through use of the product. We considered that it might have been beneficial for the study to also contain feedback from participants recording whether they had noticed an improvement in their tooth colour, and if so to what extent. In the absence of any further information relating to clinical significance in the study, we noted that a number of participants were recorded as not having received any benefit at all from one application of the product, and that the significance of the remaining results was not addressed.
For the reasons outlined above, we considered that the methodology of the study and, consequently, the significance and reliability of its results were not adequate to support the teeth whitening claims in the ad.
Further, the ad referred to teeth becoming "up to eight shades whiter" through one 20-minute application of the product. We considered that viewers would understand that a significant proportion of users would experience that result. Notwithstanding our concerns as to the study methodology, we noted that only eight per cent of the participants in the study had experienced an eight-shade improvement to their tooth shade and considered that that number fell short of the expectation created by the "up to" claim.
Finally, we noted that the ad contained a visual representation of the teeth whitening process in the form of a woman whose teeth got whiter as a marker slid from one end of a scale showing tooth colour to the other. We were concerned that that scale displayed only eight shades of tooth colour, whilst the "up to eight shades whiter" claims in the ad were based on a shade guide containing 16 incremental shades. We considered that the inclusion in the ad of the eight-shade scale created an inaccurate frame of reference for the "up to eight shades whiter" claim, with the effect of exaggerating the possible degree of change that could be achieved from use of the product.
For the reasons outlined above, we concluded that the claims had not been appropriately substantiated and were therefore misleading.
Ad (a) breached BCAP Code rules 3.1 3.1 Advertisements must not materially mislead or be likely to do so. (Misleading advertising), 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 3.12 3.12 Advertisements must not mislead by exaggerating the capability or performance of a product or service. (Exaggeration).
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), 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 3.1 3.1 Advertisements must not materially mislead or be likely to do so. (Exaggeration).
Action
The ad must not appear again in its current form. We told Fdd International Ltd to ensure they held adequate substantiation for their objective claims and that their ads did not exaggerate the capability or performance of their products.
