On 25 May 2012, Commission Regulation (EU) No 432/2012 of establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health, which was provided for by EC Regulation 1924/2006 on Nutrition and Health Claims made on Foods, was published in the Official Journal of the European Union (EU). The Regulation came into force on 14 June 2012 and began to apply from 14 December 2012.
A regional press ad, dated November 2012, for a skincare tablet stated "IMEDEEN Beautiful skin begins within. Award-winning skincare in a tablet ... Winner of several consumer and beauty awards, IMEDEEN has been pioneering skincare from within since 1991. Natural-based, scientifically tested skincare formulations for different ages that work from within to help reduce the appearance of fine lines and wrinkles. IMEDEEN is offering skin consultations using a Dermascan - the Dermascan looks at the elastin and collagen levels in the dermal layer of the skin". The ad featured a picture of a woman with text that stated "Try it. Love it. Trust it. As recommended by Sarah, 43, UK - taking IMEDEEN for 4 years".
A reader challenged whether the claim that the product "[worked] from within to help reduce the appearance of fine lines and wrinkles" was misleading and could be substantiated.
Pfizer Ltd supplied the ASA with a number of research studies, which they believed supported the efficacy of the product and the claim that the product worked from within to reduce the appearance of fine lines and wrinkles. They also strongly believed that going forward, although Imedeen was classified as a food supplement, none of the claims in the ad were health claims and were therefore outside the scope of EC Regulation 1924/2006 (the Regulation), which prevented nutrition and health claims made on foods unless they were authorised claims included on the EU Register of Nutrition and Health Claims (the Register). They also believed the claims in the ad complied with relevant Department of Health guidance.
The ASA noted Pfizer's view that the claims in the ad were not health claims and therefore outside the scope of the Regulation. We considered whether the claim "work from within to help reduce the appearance of fine lines and wrinkles", although it referred to the appearance of skin, was likely to be understood by consumers to be a health claim. We concluded that, in the context of this ad, the claim was a beauty claim rather than a health claim under the Regulation. We therefore considered that, if used in similar advertising in the future, the claim was not likely to be problematic under the CAP Code rules that mirrored the Regulation. As a beauty claim, however, it would still be subject to the rules of the CAP Code covering efficacy and substantiation.
Although the Regulation was already in force at the time the ad appeared, it did not begin to apply until 14 December 2012 and therefore, prior to that date, national regulators were required to determine whether such claims were misleading and could be substantiated.
We took independent expert advice on the six studies provided by Pfizer to support the claim that Imedeen "[worked] from within to help reduce the appearance of fine lines and wrinkles". The expert considered that three of the studies were not adequate substantiation, because they did not involve study protocols that included a non-active control or placebo throughout the whole trial period or up to the period where statistically significant changes had been reported. One of the studies consisted of only six participants, two with medical conditions that might have affected the skin or general health. In addition, pre and post treatment grading pictures were not assessed for two of the six participants.
The expert said some parts of the reporting in the remaining studies made it difficult to provide an accurate interpretation of the data. The data and statistical information in one of the studies was limited, with no standard deviations or standard error figures reported or which wrinkles or part of the face were assessed. Another used paired statistics for its calculations, whereas non-paired statistics would have been more appropriate, and the number of participants appeared to vary throughout the report. It was also unclear whether 'crows-feet' or cheek were measured at each time point for the same individual. The third study reported ultrasound density, but did not give the calculation of density or the combined epidermal and dermal thickness although listed as a measurement.
The studies involved three-, four- and six-month trials with the results measured by clinical grading, self-evaluation and visual imaging techniques, but did not use methods to assess direct measures of wrinkles before or after treatment. The expert said the trials showed a small effect in both the clinical grading of wrinkles and the ultrasound measures but, other than the clinical grading, which after six months was minimal, the data showed that participants themselves did not see the effect. Ultrasound was used to measure changes in skin thickness and density, but a consistent pattern of a definite increase in skin thickness for the active group had not been shown across the three studies.
We noted the studies involved older subjects, two studies with a mean age of 50 and therefore likely to have a high component of post-menopausal subjects, and the other specifically using post-menopausal women. We understood that post-menopausal women were known to show different cutaneous symptoms to pre-menopausal women. We considered that readers would infer from the ad, which included a picture of a 43-year-old woman who had been using the product for four years, that this was the target group for the advertised product. We understood that the majority of women in this age group would be pre-menopausal and therefore not representative of the age group in the studies. We also noted, although the studies reported on wrinkles around the eyes, they did not report on "fine lines" as claimed in the ad.
We noted the expert said the trials appeared to show a small effect in both the clinical grading of wrinkles and the ultrasound measures, although consumers were unlikely to notice the difference, but he had concerns about the thoroughness of both the data and studies. In addition, we noted the studies our expert looked at were restricted to older and, therefore likely to be post-menopausal, women and were based on only two products in the Imedeen range, neither of which was made clear in the ad.
Furthermore, we understood that the formulation of the tablets used in the trials was not the same as the product on sale at the time the ad appeared. The amount of Biological Marine Complex, the main active ingredient in the Imedeen tablets, remained at roughly the same level, but the exact formulation differed in terms of the other vitamin content of the tablets. We therefore considered that, because the formula was not the same as that tested in the trials, the studies did not support the claims for the product being advertised at the time the ad appeared.
We considered that the reports provided were not sufficiently robust to support the claim "[worked] from within to help reduce the appearance of fine lines and wrinkles" and concluded that the claim was misleading.
The ad breached CAP Code (Edition 12) rule 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising) and 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).
The ad must not appear again in its current form. We told Pfizer Ltd to ensure that they held robust substantiation for the claims made in their advertising.