Two ads for the Sanex Advanced AtopiCare range, seen in June 2016:
a. A press ad for the body lotion stated "Very dry, red skin? It could be Atopic. If your skin is red, reactive or very dry, it could be atopic. The Sanex Advanced AtopiCare Body Lotion has been especially developed for dry, atopic skin to help relieve dryness and soothe skin ...".
b. Colgate's website www.sanex.co.uk, featured a banner at the top of each page stating "NEW SANEX ADVANCED. DEVELOPED WITH DERMATOLOGISTS FOR SPECIFIC SKIN NEEDS. CLINICALLY PROVEN RESULTS". A page headed "REACTIVE, ATOPIC SKIN" contained text stating "... You know the feeling. Your skin is severely dry and can easily become reactive or irritated. What you may not know is that your skin may be atopic. But don't panic, you are not alone. Atopic skin is a common skin condition. To make your skin feel comfortable again, there are a few important steps that should be part of your daily skin routine. STEP 1 - CLEANSE. Use a gentle and hypoallergenic cleansing product with emollients, like the new Sanex Advanced AtopiCare shower cream. This helps keep your skin soft and clean, while minimising the risk of allergies and irritations. STEP 2 - MOISTURISE ... You can also try the new Sanex Advanced AtopiCare body lotion with emollients and skin-identical lipids. It's clinically proven to soothe dry, atopic skin ... STEP 3 - DON'T FORGET YOUR UNDERARM SKIN! If your underarm skin is sensitive, reactive or atopic, use the new hypoallergenic Sanex Advanced AtopiCare range to protect against itchy, tingling sensations and irritation ...".
The website also featured a video which had a voice-over stating, "Listen to your skin. When it's red, very dry or itchy, it could be telling you that you have a common problem: atopic skin. New body lotion Sanex Advanced AtopiCare. It soothes dry, atopic skin from the very first use ..." The accompanying visuals showed a close-up of skin with red patterns on it.
Unilever UK Ltd challenged whether the ads made medicinal claims for unlicensed products.
Colgate-Palmolive (UK) Ltd did not accept that these were medicinal claims. They said 'cosmetic product' was defined under EU Regulation 1223/2009 as meaning "... any substance or mixture intended to be placed in contact with the external parts of the human body ... with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours". They believed the Sanex Advanced AtopiCare range of products fell squarely within that definition. The products were typical cosmetic products consisting of a shower gel, body and hand lotion, and deodorant which could be used on dry, sensitive and atopic skin. They said the range was therefore marketed with a focus on its intended cosmetic function of protecting and keeping skin in good condition by daily care and maintenance. They pointed out that ad (b) illustrated this, as it suggested a three-step daily routine for people with dry skin.
They provided a position paper written by a dermatologist which defined "atopic skin". As outlined in the paper, they understood "atopic" skin in itself was not a disease condition, but rather a fragile and sensitive skin that benefitted from regular application of effective, high-quality, non-irritating moisturiser. More specifically, they believed the term "atopic skin" encapsulated an inactive phase where skin exhibited the symptoms of being dry, pink to red and mildly itchy. That was not necessarily a condition on a disease spectrum. It could, however, progress into the more extreme active phase, characterised by severely dry, red, cracked, inflamed skin, commonly referred to as dermatitis or eczema. They understood that some people with atopic skin in the inactive phase never experienced dermatitis or were completely able to avoid the active phase through regular moisturisation. They said that consumers who had episodes of dermatitis were easily able to distinguish between the active and inactive phases of their skin condition and would seek medicinal products during flare ups. They pointed out that ad (a) included text stating "*If you think you may have a serious skin condition, please see your doctor before using this product".
Colgate said they had purposely avoided using any language which might imply that their products were intended to treat, cure or prevent any underlying medical condition or flare up. They said the claims merely explained that the products worked by moisturising skin and were formulated with non-irritating ingredients suitable for sensitive, dry and even atopic skin. They believed that consumers understood that medicinal products contained active ingredients, such as topical steroids, that significantly reduced eczema symptoms through pharmacological activity, rather than a daily use cosmetic product intended to ensure the normal, protective moisturising layer of the skin was maintained in good working order.
They said it was well accepted under the relevant legislation and guidance that when assessing whether a product was presented as having properties for treating or preventing disease, any claims must be considered in the overall context of the product's presentation, taking into account the perception of an average consumer. They maintained that the fact the product range was marketed as being suitable for a particular skin type was not the same as claiming that it treated or prevented any underlying disease or condition. They believed they had made that clear to consumers with carefully considered wording such as "For extra dry, reactive, even atopic skin", "especially developed for dry, atopic skin" and "Sensitive to reactive skin, atopic prone". They maintained the references to the soothing qualities of the products did not imply or suggest to consumers that the products could treat or prevent any specific skin diseases and they had carefully avoided any wording that might suggest that the products were suitable for use during an active phase flare-up.
In particular, in relation to ad (a), Colgate did not believe the headline "Very dry, red skin? It could be Atopic" could be interpreted as meaning the product was able to treat or prevent a skin disease or condition when viewed in the context of the featured model who had perfect skin, text which explained that the product had been specifically developed to help relieve and soothe dry skin, and with the warning to seek medical advice in respect of serious skin conditions.
Specifically in relation to ad (b), they pointed out that the web page set out a three-step daily skin care routine to help soothe, moisturise and protect the skin (all cosmetic functions). They believed there was no implication or suggestion that the products were able to treat flare-ups, or prevent or treat any disease.
The ASA noted that Article 1(2) of the Medicinal Products Directive 2001/83/EC made clear that a substance was deemed to be a medicinal product either by virtue of its function or by virtue of its presentation. Article 2(2) of the same Directive explained that where a product fell within a definition of a “medicinal product” and within the definition of a product covered by other European legislation, the provisions of the Medicinal Products Directive applied.
We noted that the European Commission published a Guidance Document on the demarcation between the Cosmetics Products Directive 76/768 and the Medicinal Products Directive 2001/8318 (the Demarcation Guidance Document). In relation to the definition of a cosmetic product, the Guidance stated that, “A product may have a principal cosmetic purpose and also a secondary purpose to maintain the health. A secondary preventive purpose does not exclude the classification of a product as cosmetic product. However, if the product in question falls also within the definition of medicinal product (be it by virtue of its presentation or by virtue of its function, which is to be decided on a case-by-case basis), the principle of non-cumulation applies …”. We therefore considered that it was possible for a “cosmetic product” (defined in EU Regulation 1223/2009 – the Cosmetics Regulation) to have a secondary medicinal purpose without satisfying the definition of a “medicinal product”, but that where a product met the definition of both a medicinal product and a cosmetic product the provisions of the Medicinal Products Directive applied.
We noted that under the CAP Code, medicinal claims could be made for a medicinal product that was licensed by the MHRA. A medicinal claim was a claim that a product or its constituents could be used with a view to making a medical diagnosis or could treat or prevent disease, including an injury, ailment or adverse condition. With that in mind, we considered that the issues under the Code were whether or not the claims in the ads amounted to: 1. medicinal claims – i.e. whether “atopic skin” amounted to a disease and if so whether the products (a body lotion, shower gel, hand lotion and antiperspirant) were presented as preventing or treating it, in which case the products would breach the Code because they did not have a license from the MHRA; or 2. secondary medicinal claims made for products squarely fitting within the Cosmetics Regulation definition of cosmetic products (whose primary purpose is to clean, perfume, change appearance, protect, keep in good condition or correct body odour), which, in order to comply with the CAP Code, would need to be backed by evidence, be limited to preventative action and would need to make no claims to treat disease; or 3. non medicinal or medical claims but claims consistent with the products’ status as cosmetic products.
The European Commission had published a Manual on the Scope of Application of the Cosmetics Regulation (EC) No. 1223/2009 (Art. 2(1)(a)), (February 2016) (the Cosmetics Regulation Manual) which included the question “Are products for atopic skin cosmetic products?”. The answer provided was that products using claims related to atopy seemed to fall outside of the scope of the Cosmetics Regulation. However, it made clear that the use of such terms as "atopy" or “atopic skin” should be assessed on a case-by-case basis. The Cosmetics Regulation Manual stated that products presented as “appropriate for/suitable to skins with atopic tendency/atopic skin” could be qualified as cosmetic products, whereas products presented as having properties to treat or prevent atopy/atopic skin could not be.
The MHRA published “A guide to what is a medicinal product” (March 2016) (the MHRA Guidance), which explained how and on what basis the MHRA decided whether or not products were medicines. Under “Meaning of disease” the MHRA Guidance stated “When considering borderline products the MHRA considers the following examples to be medicinal claims: … references to treatment or alleviation of adverse conditions including … calms, stops itching …”. Under “What claims can I make for my product?”, the MHRA directed readers to Appendix 1, which stated that in context, a claim to “Help/help with …”, “may be a claim to treat, provide relief from and cure symptoms of disease or an adverse condition”, and that “Relieves/relief condition …” may amount to “a claim to alleviate the symptoms of disease or adverse condition”. Under “Claims to treat or prevent disease”, the MHRA stated “Saying that a product ‘may help with’ an adverse medical condition implies to the averagely well-informed consumer that the product is a treatment and such claims will bring the product within the first limb of the definition” (i.e. it would make the product medicinal by presentation). The Guidance went on to state that “As a guide the following are examples of claims which MHRA could regard to be adverse medical conditions: … to protect /prevent eczema, dermatitis and psoriasis. These are all adverse medical conditions which can be exhibited by dry, inflamed, scaly and itchy skin and products will fall to be either medicinal products or medical devices depending on their mode of action” and that “shampoos may be cosmetics or medicines, depending on the constituents and the claims being made. Those mainly intended for hygiene, or are for anti-dandruff, are likely to be cosmetic products. However, if the claims are for the alleviation or treatment of itchy scalp, or dermatitis, then the product would fall to be a medicinal product as it suggests that an underlying medical condition exists”.
We noted that the ads would be seen by a general audience. We considered that the average consumer, to whom the ads were directed through their content, was someone who believed they had “dry”, “very dry”, “red”, “itchy” or “reactive” skin. We considered that a significant proportion of such people were unlikely to be familiar with the term "atopic skin", which we understood described skin that was hypersensitive and could develop into eczema or dermatitis during a flare up.
We understood from Colgate that the products’ mode of action was solely moisturisation because of the emollients and other moisturising ingredients they contained. However, we noted that ad (a) did not mention the moisturising properties of the product, and although ad (b) did (where it stated “STEP 2 - MOISTURISE ... You can also try the new Sanex Advanced AtopiCare body lotion with emollients and skin-identical lipids”), we considered the emphasis of the ad was not on the moisturising action of the products.
In relation to ad (a), we noted that it featured an image of a model touching her skin with the headline "Very dry, red skin? It could be Atopic", and "Atopic" was emphasised by virtue of its size. The ad also stated "If your skin is red, reactive or very dry, it could be atopic. The Sanex Advanced AtopiCare Body Lotion has been especially developed for dry, atopic skin to help relieve dryness and soothe skin ...". We considered that the references to "If your skin is red, reactive or very dry, it could be Atopic" and "help relieve dryness and soothe skin" were likely to be interpreted by consumers, who were unfamiliar with the term "atopic", to mean that "atopic" was a medically recognised adverse skin condition with symptoms including red, dry and reactive skin. We also considered that the ad presented the product as having properties to treat or prevent atopic skin – e.g. where it stated "help relieve dryness and soothe skin". We noted the ad also referred to the product being "especially developed for dry, atopic skin" and directed consumers to see their doctor if they suspected they had a serious skin condition. However, we considered that did not counter the overall impression given, that atopic skin was a medical condition causing red, dry, reactive skin and that the product could treat the condition.
In relation to ad (b), we noted that the tab at the top of the web page stated "Reactive, Atopic Skin" and that a sub-heading below stated "98% confirmed* it soothes itching and irritation". Further text stated "You know the feeling. Your skin is severely dry and can easily become reactive or irritated. What you may not know is that your skin may be atopic. But don't panic, you are not alone. Atopic skin is a common skin condition". We considered the text was likely to be interpreted by consumers, who were unfamiliar with the term "atopic", to mean that "atopic" was a common medical condition and was characterised by very dry, reactive, irritated skin. We considered that references in the ad to "soothes itching and irritation", "make your skin feel comfortable again", "clinically proven to soothe dry, atopic skin", "protect against itchy, tingling sensations and irritations" and "once my skin has cleared up, I feel like a woman again" gave the impression that the AtopiCare products could treat the symptoms of "Atopic" skin. We considered that text at the top of the website which stated "Developed with Dermatologists ... Clinically proven results" contributed to that impression.
We noted that a small footnote in the ad qualified the "98% confirmed*" claim with text stating "Tested on 146 women, Europe 2014" and considered that could, in isolation, cause the average consumer to think of a cosmetic rather than medicinal product. However, we considered that was not sufficient to counter the overall impression given that "atopic" was an adverse skin condition, the symptoms of which could be treated by the AtopiCare products.
We also considered that the video, which was no longer appearing on the website, appeared to present atopic skin as an underlying medical condition, whose symptoms were skin that was "red, very dry or itchy", and presented the products as being able to treat the condition where it stated "soothes dry, atopic skin". We considered that impression was enhanced by visuals in the video which showed a representation of a close-up image of skin cells that became red and went back to their normal colour following application of the product on the skin.
For those reasons, we concluded that ads (a) and (b) made medicinal claims for unlicensed products and therefore breached the Code.
The ads breached CAP Code
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease. 12.11 12.11 Medicines must have a licence from the MHRA, VMD or under the auspices of the EMA before they are marketed. Marketing communications for medicines must conform with the licence and the product's summary of product characteristics. For the avoidance of doubt, by conforming with the product's indicated use, a marketing communication would not breach rule 12.2.
Marketing communications must not suggest that a product is "special" or "different" because it has been granted a licence by the MHRA, VMD or under the auspices of the EMA. and 12.4 12.4 Marketers must not confuse consumers by using unfamiliar scientific words for common conditions. (Medicines, medical devices, health-related products and beauty products).
The ads must not appear again in their current form. We told Colgate-Palmolive (UK) Ltd to not make medicinal claims for unlicensed products in future.