Summary of Council decision:
Three issues were investigated, all of which were Upheld.
A poster for Gold Collagen, seen on 7 January, which stated "More and more women are waking up to GOLD COLLAGEN what about you? Younger-looking skin Healthier hair Stronger nails". A footnote stated "*Based on UK clinical trials on 108 voluteers [sic] taking PURE GOLD COLLAGEN daily (Double Blind, placebo controlled, randomised clinical trial). Results published in leading medical journals. Includes vitamin C which contributes to normal collagen formation and the normal function of cartilage and skin. Includes zinc which contributes to the maintenance of normal skin, hair and nails. Includes biotin, which contributes to the maintenance of normal skin and normal hair".
The complainant challenged whether the following claims breached the Code:
1. "younger-looking skin";
2. “healthier hair”; and
3. “stronger nails”.
1. Minerva Research Labs Ltd said the statement was a cosmetic claim and that they had gathered significant consumer opinion on the efficacy of their products. They provided several reports of clinical trials, all of which had been (or were about to be) published in peer-reviewed journals, and an internal consumer perception report.
In relation to Pure Gold Collagen, Minerva provided four reports. The first related to a consumer perception trial. Surveys were completed by 396 participants at the beginning and end of the trial; 74–81% agreed that their skin was more radiant, supple, smoother, healthier, or more hydrated. The second report was a journal article describing a double-blinded, randomised, placebo-controlled trial on 108 women, who completed a self-evaluation at the end of the treatment period. Compared with placebo group results, 66% more treatment participants agreed their skin was more elastic and 121% more agreed that stretch marks were reduced. The study also analysed the surface area, total length and mean length of wrinkles at baseline and 3, 6, 9 and 12 weeks for some participants. The report stated that these metrics were all statistically significantly reduced at 9 weeks in the treatment group.
The third report was a journal article relating to a study with three arms, on 217, 10, and 67 participants. The first arm looked at skin hydration, extent of photodamage, the distribution of wrinkles, and the depth of nasolabial folds after 60 days of product use. The study reported improvements in the first three factors for proportions between 43% and 82% of the subjects who had initially reported problems in those areas, and an average improvement of 24% in nasolabial fold depth. The second arm of the test measured collagen density on the forearm and eye area after 12 weeks of product use and was placebo controlled. The report stated that a statistically significant improvement in collagen density in both areas was seen in the treatment group compared to the placebo group. The third arm of the test measured skin firmness of participants' left forearms, and stated that there were statistically significant improvements at 80 and 130 days.
The fourth report, another journal article, detailed a double-blinded, placebo-controlled, randomised trial on 18 participants over 12 weeks. The study measured the hydration, elasticity and micro-topography of the subjects' left forearms. With regard to wrinkle depth, the study concluded that at week 9 there was a statistically significant improvement against baseline. A statistically significant change in skin elasticity was observed in the treatment group against baseline values, although the study also reported no statistical significance between the treatment and placebo groups. A similar pair of results was stated in relation to skin hydration.
In relation to Active Gold Collagen, Minerva provided a journal article summarising trials of three Minerva products. It included a report of a trial on 20 male volunteers, measuring skin elasticity and dermal collagen density on the forearm. Subjects took the product for a maximum of 14 weeks; a statistically significant increase in both skin elasticity at week 14 and collagen density at weeks 8, 12 and 14 was reported.
With regard to Gold Collagen Forte, Minerva provided the same summarising article as above. The relevant portion described a 90-day double-blind, placebo-controlled, randomised trial on 60 subjects, in which skin elasticity was measured on the left forearm and self-perception questionnaires were completed. Histological examination was made of skin samples from two subjects from the treatment group. The study reported a statistically significant improvement in skin elasticity in the treatment group but not in the placebo group. The histological examination showed a reduction in both the thickening of the skin and the accumulation of abnormal elastin as a result of excessive sun exposure. It was also reported that perception of skin condition was improved after 90 days, but only in the treatment group.
Minerva provided a second report, which they said was a full report of the clinical study outlined in a preliminary manner in the summary article. The report stated that 120 people participated, with four providing histological samples. It described the same methodology as the summary article, and clarified that the histological samples were taken from participants’ buttocks. The study reported that between 91 and 95% of treatment-group subjects agreed that their skin was more elastic, more youthful or more hydrated and smoother, whereas these proportions were between 28 and 50% for the placebo group. The report also stated that a statistically significant increase in skin elasticity was observed in the treatment group but not in the placebo group. Minerva provided additional data comparing the results between participants who had undergone cosmetic treatments and those who had not, which stated that there was little difference between those groups.
Minerva also provided a pre-publication paper describing an in vitro study of the effect of collagen peptides added to adult human dermal fibroblasts, in relation to Active and Forte.
Finally, Minerva provided a document outlining the clinical trials that had been performed on a range of ingredients present in Gold Collagen supplements, including hydrolysed collagen.
Minerva said that, the submitted evidence notwithstanding, "younger-looking" was clearly an impressionistic and subjective claim. They said there was no indication in the ad of how much younger users' skin would look and that they believed many, if not all, consumers would expect the statement to be 'puffery' and therefore would not be misled. While they had made efforts to establish objective substantiation, it was a matter likely to be considered subjective to a significant degree.
2. & 3. Minerva stated that these were general health claims, which were accompanied by the three specific claims in the footnote of the ad. They understood that these accompanying statements complied with the Code in that the claims were listed as authorised in the EU Register. Minerva said they had combined the authorised claims in order to avoid repetition and aid understanding by readers. They believed consumers would not have difficulty in understanding the statements as presented and would not be misled by the manner in which they had been combined. They noted that they had accidentally substituted ‘and’ for ‘for’ in the claim relating to Vitamin C and explained that this error would be amended going forward.
Minerva said that the manner in which the generalised two-word claims were presented was unlikely to mislead the average consumer, as they would appreciate that such short statements could not provide exhaustive details of the benefits and would be understood as being more fully expressed in the accompanying authorised claims. They said that consumers might alternatively consider the statements to be mere marketing language and would therefore not be likely to be misled by them. They also provided information regarding the amount of Vitamin C, Biotin and Zinc in the products.
The ASA considered that "younger-looking skin" was a claim about the cosmetic effect of the products and was likely to be understood as such, as it focused on the appearance of skin rather than function or physiological effects. We also considered that, although the degree to which skin could be understood to look 'younger' was a subjective issue, the claim in question was an objective statement that users would see a difference in the appearance of their skin. As such, we did not agree that the claim would be perceived as 'puffery'. In light of the imagery of three women, we considered that the claim would be understood primarily in relation to women and we also considered that consumers would generally understand anti-aging claims to relate to (although not in isolation) the face. We therefore expected to see evidence to demonstrate that typical users of the three products would perceive their skin, including on their face, to have a younger-looking appearance and that this would be apparent across a range of ages and ethnicities. We understood that such effects of the oral consumption of collagen on the body were not well-established and therefore considered that the statement “younger-looking skin” was a claim for which a high standard of evidence was required, both with regard to objective changes in skin quality and consumers’ perceptions of their skin age. We reviewed the evidence provided by Minerva.
With regard to the Pure Gold Collagen consumer perception trial, although we noted that this reported a positive response to the product and that some of those properties may be related to younger-looking skin, we did not consider that these responses demonstrated that participants had perceived their skin as having a more youthful appearance. Moreover, the study had not accounted for confounding factors by using a placebo and blinding the participants and researchers.
In relation to the three other reports, which between them used a range of objective measures of skin quality and assessed participant perceptions, we noted that much of the statistical analysis was carried out against baseline data, rather than in comparison with placebo results (even where this data existed), and that some analysis was carried out at, for example, week 9 of a 12-week trial. In addition, the third paper stated that all the subjects recruited into the first arm of the trial were due to undergo facial cosmetic procedures, which we understood took place 20 days into the trial. While the study included separate results for participants whose procedures were ostensibly unrelated to the metric being measured, the report did not account for how this approach to subgroup analysis might impact on the validity of the results. We also noted that, as above, the self-evaluation statements and data relating to hydration, elasticity, firmness, collagen density, photoaging and changes in wrinkle metrics did not in themselves demonstrate an improvement in participants’ perceptions of the youthful appearance of their skin. In addition to these three main concerns, we also considered that the studies had omitted key information or contained several other causes of concern in relation to methodology that meant the trials were not sufficiently robust to support the claim, both in terms of objective measurements and perception-based evidence. In light of these concerns, we concluded that “younger-looking skin” had not been substantiated in relation to Pure Gold Collagen.
With regard to the study for Active Gold Collagen, we noted that, as well as some areas of concern in relation to methodology for a trial intended to support a marketing claim (such as the lack of placebo control), the results did not demonstrate an improvement in subjects’ perception of their skin and were described in the study as “preliminary”. We therefore considered that, in itself, this report was insufficient to substantiate “younger-looking skin” in relation to Active Gold Collagen.
In relation to Gold Collagen Forte, we took independent expert advice. We understood the same trial was described by both papers, with the 60-participant trial containing preliminary results for the full study. The preliminary summary paper reported that it had included participants who underwent cosmetic treatments (specifically, Botox and facial fillers). As outlined above, we were concerned that this would affect the reported outcomes and that this potential source of bias had not been adequately accounted for in the trial design or by independent studies. As above, although we noted the positive results stated for objective testing of elasticity, this did not in itself also demonstrate a perceivable difference in skin appearance. Furthermore, we were concerned that the analysis of the histological and consumer perception studies contained anomalies. Notwithstanding these factors, we noted that when comparing the treatment and placebo group results for participants agreeing that the product affected the look of their skin, the maximum potential benefit (comparing treatment and placebo results) was in the region of 55% of subjects, and in the region of 60% for those questions most relevant to youthfulness of skin. We considered these reported effects were insufficiently large enough to demonstrate that the product had a demonstrable effect. In light of this and other concerns about the trial design, although we noted that 93% of the treatment group agreed that their skin was ‘more youthful’ and that other perception answers were also positive in relation to wrinkles and fine lines, such results did not account for placebo group results. We therefore considered that concerns about the applicability of the chosen methodology, as well as the analysis and conclusions of the objective and perception-based trial data, precluded the positive results of the trial from substantiating the claim “younger-looking skin” in relation to Gold Collagen Forte.
We noted the paper relating to the in vitro study. However, we considered that, in light of the above concerns about the in vivo trials, this was insufficient by itself to support the claim for the products in question as it did not demonstrate real-world applicability or show an improvement in perception of skin age. In relation to the document outlining trials on Gold Collagen ingredients, we noted that the studies listed were in relation to specific ingredients rather than the formulations as sold, and several were unrelated to the claim either by the method of use, the participants chosen, or by the outcome measured. Moreover, the full papers for the studies were not provided.
Taking the above elements into account, we considered that the claim “younger-looking skin” in relation to the three products featured in the ad had not been substantiated, both with regard to objective changes in skin quality and consumers’ perceptions of their skin age. We therefore concluded that the ad breached the Code.
On this point, 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) 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).
We considered that the claim “healthier hair” would be understood as a reference to the general benefits of the products for overall good hair health. According to EC Regulation 1924/2006 on Nutrition and Health Claims made on Foods (the Regulation), which was reflected in the CAP Code, references to general benefits of a nutrient or food (including food supplements) for overall good health or health-related well-being were acceptable only if accompanied by a specific authorised health claim. We noted that the footnote in the ad included three authorised health claims relating to ingredients in the Gold Collagen products, including two in relation to hair. The claims in the ad referenced skin and nails as well as hair, but we noted the claim reflected the wording of the authorised claims “Zinc contributes to the maintenance of normal hair” and “Biotin contributes to the maintenance of normal hair”. We considered the claims in the ad therefore conveyed the same meaning to consumers as the authorised claims, in relation to the benefits of the substances for hair health. We understood that the Gold Collagen products contained sufficient of these ingredients to meet the conditions of use associated with the specific health claims in question.
However, the footnote was considerably separated from the headline claim and was presented in very small type. We considered that this combination of separation and lack of prominence meant that the accompanying authorised claims were likely to be overlooked by consumers viewing the ad, and that they should have been more prominently presented within the ad and placed next to or following the initial statement. Moreover, the parts of the footnote outlining the specific authorised health claims were preceded by information relating to clinical trials. We considered that this obscured the intention of the footnote (to clarify the nature of the headline claim) and blurred the basis on which the claim “Healthier hair” had been made.
Finally, we considered that “healthier hair” implied to consumers that using the product would improve the health of their hair. We noted that the specific authorised health claims related to the maintenance of normal hair, and considered that the implications of “healthier hair” exaggerated those claims. As such, the specific health claims used were not sufficiently relevant to appropriately accompany the headline general health claim. In light of the above factors, we considered that the ad breached the Code.
On this point, the ad breached CAP Code (Edition 12) rules 15.2 15.2 References to general benefits of a nutrient or food for overall good health or health-related well-being are acceptable only if accompanied by a specific authorised health claim. (Food, food supplements and associated health or nutrition claims) and 15.7 15.7 Nutrition and health claims for food supplements must be permitted or authorised as provided for at rule 15.1.1 above. Marketing communications that contain nutrition or health claims must be supported by documentary evidence to show they meet the conditions of use associated with the relevant claim as specified in the EU Register. (Food supplements and other vitamins and minerals).
According to the Regulation, which was reflected in the CAP Code, only health claims that appeared on the list of authorised health claims (the EU Register), or claims that would have the same meaning to the consumer, could be made in ads that promoted foods. Health claims were defined as those that stated, suggested or implied that a relationship existed between a food category, a food or one of its constituents, and health. We considered the claim “stronger nails” related to a defined effect on a particular part of the body, as it implied an improvement in the strength of nails and, therefore, their physical structure, and would consequently be understood as a specific health claim.
We noted Minerva’s view that their product met the conditions of use for authorised claims relating to the contribution of zinc and biotin for the maintenance of normal nails. We considered that, although ‘normal nails’ would have a certain degree of strength, the claim “stronger nails” would not be understood by consumers as having the same meaning as “maintenance of normal nails”. We also considered that “stronger nails” implied to consumers that using the product would make their nails stronger than they had been before, and that the implications of “stronger nails” therefore exaggerated the authorised claims relating to “normal nails”. Finally, we considered that “stronger nails” in the context of the ad would be understood in relation to the advertised products themselves and not with regard to zinc and biotin specifically. We noted that the EU Register did not contain any authorised claims for Gold Collagen products and that the claim ‘stronger nails’ did not appear in the Register in relation to any ingredients. In light of the above, we considered that “stronger nails” was not an authorised specific health claim or a claim that would hold the same meaning for consumers, and concluded that the ad breached the Code.
On this point, the ad breached CAP Code (Edition 12) rules
Marketing communications that contain nutrition or health claims must be supported by documentary evidence to show they meet the conditions of use associated with the relevant claim, as specified in the EU Register. Claims must be presented clearly and without exaggeration.
Only nutrition claims listed in the updated Annex of the EU Regulation (as reproduced in the EU Register) may be used in marketing communications.
Only health claims listed as authorised in the EU Register, or claims that would have the same meaning to the consumer may be used in marketing communications.
http://www.ec.europa.eu/food/food/labellingnutrition/claims/community_register/authorised_health_claims_en.htm. (Food, food supplements and associated health or nutrition claims) and 15.7 15.7 Nutrition and health claims for food supplements must be permitted or authorised as provided for at rule 15.1.1 above. Marketing communications that contain nutrition or health claims must be supported by documentary evidence to show they meet the conditions of use associated with the relevant claim as specified in the EU Register. Food supplements and other vitamins and minerals).
The ad must not appear again in the form complained about. We told Minerva Research Labs Ltd to ensure that future ads did not make efficacy claims about the cosmetic effects of Gold Collagen unless they held documentary evidence to substantiate them. We also told them to ensure that claims about the general benefits of their products for overall good health were accompanied by a suitably prominent authorised specific health claim, and that any specific health claims made in their ads were authorised and appropriately worded.