Summary of Council decision:
Two issues were investigated, both of which were Upheld.
A magazine ad for Seven Seas Perfect 7 Renewal Advanced supplements, seen on 21 October 2018, featured text positioned over a women’s cheek which stated "WRINKLES APPEARANCE REDUCTION, SKIN FIRMNESS, SKIN MOISTURE, SKIN SMOOTHNESS, SKIN ELASTICITY, SKIN RADIANCE, SKIN SOFTNESS". Further text stated "NEW PERFECT7 RENEWAL IS A UNIQUE FORMULATION CONTAINING CERAMOSIDES. A NATURAL SOURCE OF CERAMIDES, FOR MORE HYDRATED LOOKING SKIN, FROM WITHIN".
1. The complainant challenged the claims “skin moisture” and “for more hydrated looking skin, from within”, which were health claims which must be authorised on the EU Register of nutrition and health claims made on foods.
2. The complainant also challenged whether the claims “wrinkles appearance reduction", "skin firmness", "skin smoothness", "skin elasticity", "skin radiance" and "skin softness" were misleading and could be substantiated.
1. Seven Seas Ltd said that both of these were cosmetic claims. They provided a copy of a randomised clinical trial which they believed substantiated the claims “skin moisture” and “for more hydrated skin, from within”.
2. Seven Seas provided confidential information which they believed substantiated the claim "Wrinkles Appearance Reduction". That information came from an excerpt from a study on the reduction of appearance of wrinkles over 60 days. Seven Seas believed the clinical trial referred to above also substantiated the claims "skin firmness", "skin smoothness", "skin elasticity" and "skin softness". In respect of the claim “skin radiance”, Seven Seas referred to a study into the appearance benefits of skin moisturising. They said the outer layer of the skin, the stratum corneum and its structure needed to be hydrated in order for it to allow more incident light to reach the subsurface layers and create the glow of radiance.
According to Regulation (EC) 1924/2006 on nutrition and health claims made on foods (the Regulation), which was reflected in the CAP Code, only health claims listed as authorised on the EU Register of nutrition and health claims (the EU Register) could be made in ads promoting foods. Health claims were defined as those that stated, suggested or implied a relationship between a food, or ingredient, and health. The ASA understood that the function of the skin was to provide a permeable barrier against the external environment. We considered that claims which stated or implied a beneficial physiological effect on or change to the structure of the skin to aid in its function of providing a permeable barrier were health claims for the purposes of the Regulation. In contrast, claims which related to temporary improvements in appearance or maintenance of normal appearance of skin did not refer to a beneficial physiological effect on a specific function of the skin and therefore were cosmetic, rather than health claims. The Regulation therefore did not apply to such claims. We considered that the interpretation of such claims as health or cosmetic claims depended on the specific claims made and the overall context of the ad.
We considered that the claims “skin moisture” and “for more hydrated looking skin, from within” would be understood by consumers as a reference to the benefits of the product in providing hydration to the skin. While we acknowledged the inclusion of the words “hydrated looking” which could been seen as a reference to a cosmetic effect on the skin, we considered the claims implied that the product had a specific physiological action on the body which would have a beneficial health effect on a function of the skin, in particular by protecting the skin against dehydration. We therefore considered that both claims were specific health claims. However, we had not seen evidence that either health claim “skin moisture” or “for more hydrated looking skin, from within” were authorised on the EU Register. In light of that, we concluded that the claims breached the Code.
On that 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. (Foods, food supplements and associated health and 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 15.1 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. 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 claims “wrinkles appearance reduction", "skin firmness", "skin smoothness", "skin elasticity", "skin radiance" and "skin softness" did not reference a specific effect on the function of the skin. In that context, we considered that consumers were likely to understand the claims to be cosmetic claims about the product’s beneficial effect on the appearance and texture of the skin.
We considered the evidence in support of the cosmetic claims. Seven Seas provided a double-blinded, placebo-controlled trial which investigated the efficacy of oral administration of wheat polar lipids complex (WPLC) on 60 women aged between 30 and 60 years. Twenty subjects were given two capsules of WPLC in oil form daily (70 mg per day), which was the same amount of ceramosides as in one capsule of Perfect 7 Renewal Advanced and 20 subjects were given a capsule containing a placebo. A further 20 were also given WPLC in a powder form, which was not relevant to the claims.
Skin elasticity was measured using a Cutometer, a non-invasive suction skin elasticity measure. Results showed a statistically significant increase after 15, 30 and 60 days of supplementation compared to the placebo, which remained unchanged at the 60-day mark. Skin smoothness was measured using Visionscan, a high-resolution UVA-light video camera. The results showed a statistically significant increase in skin smoothness over 60 days of supplementation compared to the placebo. In addition, 85% of subjects who took the relevant WPLC answered ‘yes’ to the question “Do you think that your skin is softer and smoother?” on a self-assessment questionnaire at the end of the period. While we acknowledged the results, we did not consider the trial large enough to demonstrate the effects of the product on women generally. Only the results of 40 participants were applicable and in addition, it had only been conducted on Caucasian women. We considered, consequently, that the results could not be extrapolated and that the trial should have been carried out on a larger, more representative cross-section of a population similar to that of the UK at which the product was targeted.
We also noted that the participants went through a five-day conditioning period. Within that period, they were given a basal night and day cream to standardise topical application on the skin across the group. The cream had no claimed effect on the skin by topical application and participants were required not to use any other cosmetic product during the conditioning or trial period. However, no information was given on the consumption of water during the trial period and whether that was regulated. Also, we were given no information as to whether any of the participants consumed the product with water. In addition, because the amount of water consumed would have an effect on the hydration of the skin and consequently its elasticity, we considered the trial was insufficient to support the claimed effects of the product. We noted Seven Seas said that for the claim “skin radiance”, hydrated skin allowed more incident light in, creating the effect of shiny skin.
We also noted their comments in relation to the claim “skin firmness”, that in addition to the skin elasticity results measured by the Cutometer in the clinical trial, the skin needed the correct moisture levels to lead to firmness. To measure the moisturising effects of the product, Seven Seas referred to the results of a self-assessment questionnaire taken in the clinical trial, where participants were asked after 60 days, “How do you evaluate the food supplement’s efficacy concerning skin moisturising level improvement?”. Those who took the supplement responded positively to the question. Notwithstanding the fact that we had not seen evidence that claims about skin moisturising were authorised on the EU Register as discussed in point 1, we did not consider that by itself, a self-assessment questionnaire based on perception demonstrated that the product provided “skin radiance” and “skin firmness”.
We also considered the evidence provided in relation to the claim “wrinkles appearance reduction”. We had not been provided with a full copy of the clinical trial. We had no information on how the participants of the trial were chosen or how the randomisation was carried out. While we had been provided with a graph to demonstrate the results after 60 days, we had not been provided with information as to whether the comparison of results was based on all participants as originally allocated after randomisation, or whether it was based only on those participants who completed the treatment originally allocated. We also had not been provided with any information on the methodology of the trial. Consequently, we could neither be sure that the results of all participants had been captured nor of the robustness of the trial as a whole. We therefore considered the claim “wrinkles appearance reduction” had not been substantiated and consequently breached the Code.
On that 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).
The ad must not appear again in its current form. We told Seven Seas Ltd to ensure that their future advertising did not include specific health claims that were not authorised on the EU Register and to ensure that they held robust evidence to substantiate cosmetic claims.