A website, www.clearasil.co.uk, seen on 15 November 2017 featured text that stated "Clearasil Rapid Action Treatment Cream When fighting breakouts, faster is better. Clearasil Rapid Action Treatment Cream is clinically proven to visibly reduce spot size and redness in as fast as 4 hours …".
The complainant challenged whether the ad made medicinal claims for unlicensed products.
RB UK Commercial Ltd said that their Clearasil Rapid Action Treatment Cream was placed on the UK market as a cosmetic product and not a medicine.
RB UK said that as per the Cosmetics Regulation (EC) No 1223/2009, a cosmetic product "means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity 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 …".
RB UK stated that the cream's intended purpose was to be used on the external part of the epidermis to keep skin in good condition and to change the appearance of the skin. They said that spots and blemishes were associated with a blockage in the normal sebaceous follicles on human skin. The blockage was caused by a combination of shed skin cells and excess sebum. The blocked follicle could cause a build-up of pressure and lead to a build-up of bacteria, causing the appearance of redness.
RB UK said that the cream contained salicylic acid, which delivered a cosmetic keratolytic action by physically removing dead skin cells from the blocked follicles. Salicylic acid was present in the product, in line with the maximum permitted concentration in ready-for-use preparation of 2.0%, as detailed in Annex III/98 of (EC) No 1223/2009.
RB UK said that the claims about visibly reducing spot size and redness were linked to changing the appearance of the skin and keeping the skin in good condition by the physical keratolytic action of removing dead skin cells. That consequently relieved pressure and redness caused by unblocking of follicles, which was in line with the product's cosmetic purposes.
RB UK said that as per Article1(2) of Directive 2001/83/EC on medicinal products for human use, a medicinal product was "(a) any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis".
RB UK said that the manner in which the product worked was not by restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action. Furthermore, they said that the ad did not claim or imply that the cream had a specific therapeutic benefit in regards to spots.
RB UK stated that the product was a cosmetic cream for spots and not a medicinal treatment for acne. They conducted an online survey of 369 people who had bought a skin care product for facial spots in the last six months. The results showed that: 51.22% did not perceive spots to mean the same thing as acne, 43.9% thought that they were the same thing and 4.88% did not know; 58.54% did not think that all people who experienced spots on their face would also be described as having acne, 31.17% did think that that was the case and 10.3% did not know; 81.3% perceived it was possible to have spots on the face without having acne, 11.65% perceived that it was not possible and 7.05% did not know; 81.03% agreed it was possible to have a breakout of spots without having acne, 11.65% thought it was not possible and 7.32% did not know; and 70.46% did not think all spot breakouts were acne, 20.6% thought it was and 8.94% did not know. RB UK therefore believed that the survey results demonstrated that consumers were aware that there was a difference between spots and having acne.
RB UK referred to a piece of guidance for advertising claims on cosmetic products, which was published by a trade body for companies involved in making, supplying and selling cosmetic and personal care products.
RB UK said that the guidance referenced the European Commission guidance (05/ENTR/COS/79) on the demarcation between cosmetic and medicinal products, which stated "All cosmetic products will, to some extent, affect the physiology of the tissues to which they have been applied …". RB UK Commercial said that the guidance provided clarification on the meaning of physiological activity, which stated that the sentence as a whole must be read whereby a medicinal product was defined as "any substance … used or administered … with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological immunological or metabolic action …". Furthermore, the guidance stated that any such pharmacological, immunological or metabolic modification had to be more than insignificant. The guidance also stated that if the restoration, correction or modification of the physiological function was not through one of those three actions, the product was not a medicinal product regardless of the magnitude or significance of the effect produced. Cosmetic products could have physiological effects, but that did not necessarily make them medicinal products; and the magnitude of any effect alone did not make the product a medicinal product.
RB UK believed that the product met the criteria for a cosmetic product in its formulation, mode of action, presentation and that the claim was one that was permissible to be made on the product under that classification.
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. We understood that meant that a product could be rendered medicinal by its functional effect on the body, or by presenting itself as having properties for treating or preventing disease. 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. 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, including the Cosmetics Regulation, the provisions of the Medicinal Products Directive applied.
The Cosmetics Regulation defined a cosmetic product as a product the primary purpose of which was to clean, perfume, change appearance, protect, keep in good condition, or correct body odour. 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 a 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 understood that it was possible for a "cosmetic product" (defined in the Cosmetics Regulation) to have a secondary purpose to maintain health without meeting 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. We considered that the issues under the Code were whether or not the claims in the ads amounted to: 1. medicinal claims; 2. secondary claims made for products squarely fitting within the Cosmetics Regulation definition of cosmetic products, which would need to be limited to preventive action and would need to make no claims to treat disease, including adverse conditions; or 3. non medicinal or medical claims but claims consistent with the products' status as cosmetic products.
We sought advice from the MHRA. They considered that acne was an adverse medical condition and that claims which stated or implied that a product could prevent or treat acne were medicinal claims. In their view, "spots" would most commonly be associated in public perception with acne, and therefore claims to prevent or treat them would also likely be seen as medicinal. However, they did not consider claims to prevent blackheads to be medicinal claims, as blackheads were not an adverse medical condition.
The MHRA noted that the definition of a cosmetic product encompassed products the primary purpose of which was to "change appearance". In their view "cosmetic" change was temporary and intended to improve the appearance of something without changing its basic structure. For spots this would normally be achieved by masking, disguising or covering.
We also referred to the Manual of the EC Working Group on Cosmetic Products (Sub-Group on Borderline Products) on the scope of the application of the Cosmetics Regulation (the Manual). While the most recent version of the Manual post-dated the ads as they were originally seen, we considered that it provided useful guidance on interpretation of the terms "spots" and "acne". The Manual stated "Acne is a state of the skin that is often characterised by the presence of persistent spots, excessive seborrhoea, infection, inflammation and skin damage. Therefore, products that are presented, either explicitly or implicitly, for use in the prevention or treatment of acne (e.g. Acne vulgaris) or other inflammatory lesions of the skin (such as papules and pustules) do not fulfil the definition of a cosmetic product and, as such should not be placed onto the EU market under the cosmetics regulatory framework". It also stated that "products that function to prevent the formation of spots or function to protect the face from spots through a cleansing action may fulfil the cosmetic definition depending on how the product is presented, the claims that are made about the product and the ingredients used in the product. Such products should not make explicit or implicit claims related to the prevention or treatment of acne. Claims made for products used for spots should comply with the functions expected of a cosmetic product such as to clean, protect or keep the skin in good condition by effectively removing clogged sebum duct (so-called "pores"), accumulated sebum and debris from the skin given that such effects are generally considered to only affect the appearance of primary comedones but do not prevent or treat acne".
We considered that consumers would likely understand "acne" to refer to the widespread, persistent occurrence of skin inflammations, commonly referred to individually as "spots", which we understood to be caused by clogged sebum ducts. We acknowledged that the term "spots" was commonly used by consumers to describe a range of skin issues, including those caused by normal teenage development or hormonal cycles, at lower levels and on a less frequent basis, which would not be considered as problematic as more severe or persistent outbreaks of skin blemishes. We therefore considered that consumers' understanding of "spots" would be highly dependent on the context of the claim. It could be acceptable for claims to help prevent spots to be made in relation to products that squarely met the requirements of the Cosmetics Regulation, provided that advertisers made clear that they were intended, as a secondary outcome of a function that was clearly presented as primarily cosmetic, to prevent the occurrence of occasional, individual spots or small numbers of spots, as opposed to acne (as it would likely be understood by consumers).
We understood that blackheads were non-inflamed, open pores blocked by oil or dirt, resulting in pigmentation. We considered that a product that was presented as having a physical effect to remove blackheads would likely be regarded by consumers as having a cosmetic, rather than a medicinal action.
We understood that the active ingredient in Clearasil Rapid Action Treatment Cream was 2% salicylic acid, which acted as an exfoliant and was authorised for use in cosmetic products. We considered that the product did not correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, and therefore it did not fall under the functional limb of the definition of a medicinal product as defined in the Medicines Directive. However, the product was named "Clearasil Rapid Action Treatment Cream" and the ad stated "When fighting breakouts, faster is better" and "Clearasil Rapid Action Treatment Cream is clinically proven to visibly reduce spot size and redness in as fast as 4 hours". We considered that consumers would understand that its primary purpose was to treat existing spots, and therefore it could not carry a secondary preventative claim. We considered that the claims amounted to medicinal claims.
We considered that the term "breakouts" did not inevitably bear the same meaning as acne. However, we considered that the term "breakouts" could be understood by consumers to refer to a variety of skin conditions, and in the absence of more specific information, consumers would likely interpret it to apply to occurrences of multiple spots, including more persistent and severe occurrences, and acne
We reviewed the survey RB UK had conducted on participants' understanding of spots and acne, but noted that respondents were not shown the ad in question. Therefore, respondents were not asked how they would interpret the specific claims, "When fighting breakouts, faster is better" and "Clearasil Rapid Action Treatment Cream is clinically proven to visibly reduce spot size and redness in as fast as 4 hours". We further noted the results showed that a significant proportion of respondents considered acne to have the same meaning as spots and breakouts, which indicated that consumers understanding of "spots" and "breakouts" would be highly dependent on the claim in question. As such, the survey did not alter our assessment that the claims in the ad were medicinal.
Because the ad made medicinal claims, when we understood that the cream was not a licensed medicine, we concluded the ad breached the CAP Code.
The ad breached CAP Code (Edition 12) rules
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. and 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. (Medicines, medical devices, health-related products and beauty products).
The ad must not appear again in its current form. We told RB UK Commercial Ltd not to make medicinal claims for unlicensed products, in particular claims that stated or implied that their products could prevent or treat acne, or treat spots. When making claims to prevent spots, we told them to ensure that the products and claims in question met the requirements for secondary preventive claims for cosmetic products.