A web page on the Dermalogica website www.dermalogica.co.uk, promoting the MediBac clearing product range, seen on 24 November 2017, stated “medibac clearing Clearer skin starts now: bring the four contributing factors of acne under control. The MediBac Clearing® system works to treat, clear and prevent adult acne while addressing the needs of adult skin. Most products and treatments for acne are designed for teenage skin, making them too harsh and irritating for adult acne sufferers. MediBac Clearing controls acne without compromising skin’s integrity, which means skin is clearer and healthier … how it works … Dermalogica’s MediBac Clearing system is formulated specifically to treat adult acne. Each product, with its unique acne-fighting and clearing ingredients, is designed to be layered upon the skin to provide around-the-clock, maximum control of the main factors that contribute to acne”.
Two complainants challenged whether the ad made medicinal claims for unlicensed products.
Dermalogica (UK) Ltd proposed to amend the claims by removing references to acne and replacing them with the terms “breakout” or “blemish”.
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 by virtue of either its function or its presentation. We understood that meant that a product could be rendered medicinal by its actual effect on the body, or by presenting itself as having properties for treating or preventing disease. A medicinal claim was one 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, 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 the 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, in order to comply with the CAP Code, would need to be backed by evidence, 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.
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 “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 products within the Medibac range were all cosmetic by nature. However, we considered that the claims “clearer skin starts now: bring the four contributing factors of acne under control” and “the MediBac Clearing system works to treat, clear and prevent adult acne while addressing the needs of adult skin” indicated that the product could treat acne, an adverse medical condition, and were therefore medicinal claims. Because the ad claimed to treat an adverse medical condition, it could not therefore be considered a secondary claim, regardless of whether or not the product was presented as having a primarily cosmetic function.
We acknowledged the advertiser’s proposal to amend the claims to refer to the treatment and prevention of blemishes or breakouts. However, we considered that in the context in which the claims were presented those changes would not be sufficient as they would still be understood by consumers, in the absence of supporting information, to mean that the product could prevent or treat occurrences of multiple spots, including more persistent and severe occurrences, and acne, and were accordingly medicinal claims.
We concluded that the ad made medicinal claims for an unlicensed product and therefore breached the 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 the form complained about. We told Dermalogica (UK) Ltd to remove the claims which referred to the treatment of acne and not to make medicinal claims for unlicensed products, in particular claims that stated or implied that their products could prevent or treat acne.