Two ads for Feelunique, an online beauty products retailer, seen in November 2017:
a. A paid-for Google ad stated "Acne Treatments".
b. A web page on www.feelunique.com stated, "Women's Skincare For Acne & Problem Skin". Further text stated "When it comes to problem skin treatments, we’ve assembled the world’s top products to help you keep your skin clear. Think Clinique, La Roche-Posay, Murad, Bioderma, ELEMIS and Vichy to name but a few. Acne can strike no matter what age you are and when it does, it can seriously dent your confidence. But today, there’s a host of incredibly powerful anti-blemish solutions out there to blast spots and keep breakouts at bay. We’ve combined a team of effective acne treatment kits, on the spot treatments, balancing cleansers, exfoliators, clarifying lotions and oil-free moisturisers to have your skin at its blemish-free best.”
The complainant challenged whether the ads made medicinal claims for unlicensed products.
Feelunique International Ltd said that there were many products widely available on the market that made claims to treat acne so it seemed strange as a retailer that they could not direct their customers to products that made this claim. Several other online retailers used similar wording and website categorisation. They said that the wording on their website did not claim that all the products listed were for the treatment of acne. They said “acne” was a term that was used in a broad context by consumers. While they had not carried out consumer research in this area, they thought it was unlikely that consumers thought of acne in the same way as they might a condition such as diabetes or appendicitis. Therefore it might not be right to define acne as a strict medical term in this context. They said that they were willing to make changes to their advertising if requested.
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 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 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 that 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.
Ad (a) stated “Acne Treatments”, above a link to www.feelunique.com. We considered that consumers would understand the claim to mean that Feelunique sold products that would treat acne. We noted that the website sold a range of cosmetic products, and did not sell licensed medicines. We therefore concluded that ad (a) made a medicinal claim in relation to unlicensed products and breached the Code.
Ad (b) was headed "Women's Skincare For Acne & Problem Skin", and listed a large number of products. We considered that consumers would understand that the descriptive text at the top of the page applied to at least some of the products listed beneath it. We understood that those products were all cosmetic by function. The text at the top of the page stated “problem skin treatments”, “help you keep your skin clear”, “anti-blemish solutions”, “blast spots”, “keep breakouts at bay”, “acne treatment kits”, “on the spot treatments” and “blemish-free”. It also stated “acne can strike at no matter what age you are and when it does, it can seriously dent your confidence”. We considered that consumers would understand the combination of claims, in the context of the page, to mean that the products listed could prevent and/or treat acne. We therefore concluded that the ad made medicinal claims for unlicensed products and breached the Code.
Ads (a) and (b) 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).
Ads (a) and (b) must not appear again in the forms complained about. We told Feelunique International 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.